Deadline 2013 – Implementing an Aggregate Spend Strategy

is being presented by Katherine Norris, Spectranetics & Kim Life, Life Compliance Solutions and airs on Tuesday, August 28th, 2012.  For more details or to register, please visit our site at www.fxconferences.com

The Affordable Care Act has survived Supreme Court scrutiny and the physician payment sunshine provisions are set for implementation beginning in January 2013. As the timeframe for implementation narrows and final regulations still await reporting companies, pharmaceutical, medical device and biotechnology firms are primed to implement or refine approaches to recording, tracking, and reporting aggregate payments.

While money spent, per physician, on gifts, honoraria, consulting fees, food, research, continuing medical education and clinical investigator payments will be made public at the federal level for the first time in 2014, many states have existing requirements that have provided testing grounds for methodologies over the last several years. This audio conference presentation focuses on the myriad challenges facing firms at all stages of implementation, including selecting a vendor for your reporting solution, preparing your systems and implementation, auditing and monitoring.

Implementing the FDA Guidance on Investigator Responsibility

is being presented by Lorry Witte, RN, BA, CCRC, CCRA, Clinical Research Consultant and airs on  Wednesday, August 22nd, 2012.  For more details or to register, please visit our site at http://www.fxconferences.com/Implementing-the-FDA-Guidance-on-Investigator-Responsibility-P1009.aspx

It's been some time since FDA released its guidance for industry on investigator responsibilities, but it remains important for investigators, study coordinators, and sponsor staff to regularly train on its content to ensure safe, high quality, efficient, and less costly clinical study conduct. With many studies, time is wasted on “cleaning up” study documentation. However, if all research staff members understand FDA’s current thinking on investigator responsibility, it becomes easier to collaborate in the subjects’ best interest and produce better study results.

This audio conference is intended help investigators and sponsors avoid FDA Form 483 findings and Warning Letters, highlighting what constitutes adequate investigator supervision, appropriate task delegation and adequate study training. Our speaker provides insight and guidance to assist investigators in developing or enhancing their plans for supervision and oversight of clinical trials. After attending the presentation, sponsor staff will be able to better identify robust investigator plans and understand sponsor responsibilities described in the guidance.
The presentation also reviews the protection of rights, safety and welfare of study subjects by providing reasonable medical care necessitated by clinical trial participation, reasonable access to medical care, and importance of avoiding protocol violations that present unreasonable risks for subjects.

Self-Assessment of Human Subjects Protection Programs

is being presented by Eric Allen, Director, Office of Research Compliance, with University of North Carolina at Greensboro and airs on Wednesday, June 13th, 2012. For more details or to register, please visit our site at www.fxconferences.com

Sometimes being your own worst critic is a good thing. In the case of human subjects protection programs, it can prevent your institution from devastating negative impacts if you can handle the truth. Self-assessment is one option that shows the federal government, institutional officials, and your research communities your dedication to ethics and excellence in human participant research. This dynamic presentation demonstrates how periodic self-assessment of your human research protection program can be monumentally less painful than inspections by the Office of Human Research Protection or the FDA. Our speaker addresses core components including the regulatory parameters, procedures, personnel, training, and implementation of change(s). The presentation covers practical and cost-efficient strategies to implement a self-assessment program, along with tactical approaches to avoid pitfalls.

Process Capability Indices in Medical Device Manufacturing

is being presented by Dan O’Leary, President, of Ombu Enterprises, LLC, and airs on Thursday, June 7th, 2012.  For more details, or to register please visit our site at www.fxconferences.com

Process capability analysis examines the inherent variability in a process, including the statistical distribution of the process output. When the measurement uses variables, data process variability is the “spread” of a process in statistical control. When the measurement involves attributes, process capability is often the proportion of nonconforming units. Often, process capability uses an index that relates process variability and process specifications.

This audio conference explains the underlying statistics of the most commonly used capability indices. In particular, the presentation shows how to use data from x-bar and R charts to calculate these process capability indices. With an understanding of process capability indices, the speaker then examines applications for medical devices. This immediately brings in the FDA QSR requirement to identify valid statistical techniques to control process capability and product characteristics. The audio conference illustrates applications of process capability indices in both FDA QSR and ISO 13485 systems using both examples and FDA Warning Letters to illustrate the issues.

Crisis Management for the FDA-Regulated Company

is being presented by Michael A. Swit, Esq., Special Counsel, FDA Practice, with Duane Morris LLP and airs on Tuesday, May 22nd, 2012. For more details, or to register please visit our site at www.fxconferences.com

At any moment, lightning can strike your FDA-regulated company. It may take the form of an unexpected serious adverse event such as a death attributed to your product, forcing you to consider a recall -- or an FDA inspection exposing severe quality issues – or a tampering incident such as J&J faced twice with Tylenol®. Regardless of how the crisis arises, it is vital that your company be prepared in advance to address the crisis immediately and responsibly.

This audio conference looks at key issues and FDA-regulated company might face during a crisis related to products or operations regulated by FDA, and how to respond to them. Drawing on a real-life case study that directly involved the speaker – the generic drug scandal that rocked FDA and industry during the late 1980s – the presentation reviews how to be prepared for a crisis and how to respond when one arises.
One never expects to be struck by lightning, and if you are not prepared in advance, it likely will be too late to react in the best manner to protect not only the public health, but also to responsibly mitigate the impact on your company and all its stakeholders from employees to shareholders.

Dollars and Sense – The Cost of Quality (COQ) Model and the Bottom Line

is being presented by Rene D. Massengale, President, of Global Food Quality Concepts, LLC and airs on Wednesday, May 16th, 2012.  For more details, or to register please visit our site at www.fxconferences.com

The food and beverage industry is faced with increasing pressure to improve the safety and quality of products for human consumption while still maintaining a profitable bottom line. Successful companies understand that quality management is vital to successfully meeting this challenge, but how does the cost of quality affect the bottom line?

Cost of Quality is defined as the cost associated with detecting and avoiding quality failures. It is the cost associated with monitoring, detecting, and correcting errors in manufacturing or personnel. A Cost of Quality model is a quality management tool that can be integrated into other quality management systems to better understand and track the cost of quality failure over time. It translates the language of quality into the language of dollars understood by senior management.

This audio conference presentation explores quality costs, the Cost of Quality (COQ) model, and how it can be used to measure the real benefit derived from quality management efforts. In addition, our speaker discusses how Cost of Quality can be used to track the impact of quality compliance and noncompliance on the organization’s revenues from a risk management perspective.

Industry Update – Europe's New Pharmacovigilance Regulations

is being presented by Dr. Ulrich Granzer, President, Granzer Regulatory Consulting & Services and airs on Tuesday, May 15th, 2012.  For more details, or to register please visit our site at www.fxconferences.com

The EU parliament and the EU Council have issued a new pharmacovigilance regulation, which will come into force in July. The legislation defines new and additional tasks and responsibilities for the Coordination Group, defines a new “urgent union procedure” for pharmacovigilance, and also provides a definition for post authorization safety and efficacy studies and how these new tasks are to be performed. For this particular set of tasks a new body is being established, called PRAC, which will perform safety evaluations. Opinions of the PRAC will then be adopted by the EMA or, in the case of older or national registrations, the Coordination Group for the Decentralized and the Mutual recognition procedure, the CMDh. This new system will be in charge of all critical pharmacovigilance items and issues.
In this audio conference presentation, our speaker discusses these new changes to the EU pharmacovigilance rules, as well as potential critical issues arising from the EU’s complexity and decision-making process.

HFE Usability Testing: Medical Device Industry Panel

is being presented by Maria Shepherd & Kathleen Whanger, President & Senior Quality Engineer, with Data Decision Group & Boston Scientific and airs on Thursday, May 10th, 2012.  For more details or to register, please visit our site at www.fxconferences.com

The Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design was released by the FDA in June, 2011. It states that, as part of design control, manufacturers must conduct a risk analysis to assess/mitigate risks associated with device use. In addition, the FDA expects the manufacturer will perform human factors engineering and usability testing as a part of the product development process.

FDA takes these human factors requirements seriously, requiring a systematic assessment that incorporates usability testing to determine how the device will be used, the environment in which it will be used, and existing use-related hazards. Under these circumstances, manufacturers should provide FDA with a report that summarizes the human factors processes, evaluations, and results of validation testing as part of their pre-market applications or submission.

Meeting the Linguistic Requirements for EMA Submissions

is being presented by Anabel Pérez, Senior Project Manager, with ForeignExchange Translations and airs on Wednesday, May 9th, 2012. For more details or to register, please visit our site at www.fxconferences.com

Translating product information documents in preparation for an EMA submission can be a frustrating, complex and lengthy process for both pharmaceutical companies and their translation providers. However, by establishing and maintaining communication from the start of the project, and by working together to establish realistic timelines and achievable milestones, many of the common headaches can be avoided.

In this audio conference presentation, our speaker outlines the pain points often encountered when translating for an EMA submission, and proposes solutions, innovations and best practices that will allow client and supplier to work together collaboratively to meet all the EMA requirements, and make for a smoother submission.

From Site to Sample: Considerations for Effective Minimal Risk Diagnostic Research

is being presented by Kathleen Mandziuk & Cathy Michael, Scientific Affairs Director & Senior Director of Comprehensive Solutions, with PRA & BioStorage Technologies and airs on Thursday, May 3rd, 2012. For more details or to register, please visit our site at www.fxconferences.com

*PRA is sponsoring this event, making it complimentary for all registered attendees. Please register for this event, and submit complete attendee information once you've registered, so we can assure you a space in the webinar. Incomplete registrations will not be honored. Please register each line for your group separately.*

Webinar highlights

The exponential increase of discovery, validation and commercialization of diagnostic and companion biomarkers has lead to a greater need for effective, efficient and proven research methods. Many industry experts focus on processing biological samples – however, what happens beforehand to ensure high-quality samples and data is collected?.

This educational webinar will focus on the evolving space of biomarker research and established techniques for cost-effective high-quality execution strategies. The speaker will cover a wide variety of topics from various industry perspectives.

What's New with Investigational Device Exemptions (IDE)?

is being presented by Cheryl Hill, Regulatory Manager, with Pleiad Inc. and airs on Wednesday, May 2nd, 2012. For more details or to register, please visit our site at www.fxconferences.com

Is the IDE program changing? Over the past 12 months FDA has released several proposed rules, final rules, draft guidances and final guidance documents. Some of these documents have an immediate impact on the IDE program, such as the final rule regarding Informed Consent Elements. This rule mandates that for all applicable device (or drug/biologic) clinical trials, informed consent documents and processes include a specific statement that the clinical trial information will be entered into a databank – with a compliance date of March 2012. Other documents, such as the draft guidance FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations, which explains all possible decision outcomes of an IDE submission, provide insight into the IDE program and Agency expectations.

This audio conference presentation provides an overview of these documents, as our speaker explains their impact on IDE regulations and offers suggestions for compliance.

FSMA and Traceability – Complying With FDA's New Requirements

is being presented by Pamela Sweeten, Principal, of P. Sweeten Consulting and airs on Tuesday, May 1st, 2012. For more details or to register, please visit our site at www.fxconferences.com

Under the traceability provisions of the Food Safety Modernization Act, food producers, manufacturers and distributors must be able to provide FDA with all of the data necessary data to facilitate a product recall with as little as four hours notice. So what does this mean in practical terms? How should your company go about capturing and storing all that data?

This timely audio conference presentation looks at what FDA will require from growers, packers, processors and shippers to accurately track processes, and what specific issues are likely to arise based on these new rules in a real-world context. Our speaker provides attendees with valuable insight into which changes should be of most concern, what they can expect in the coming months, and how best to prepare.

Managing Legal and PR Risks in Social Media

is being presented by Allison Fitzpatrick & Laura J. Protzmann, Partner & Counsel, of Davis & Gilbert LLP & The Dannon Company, Inc. and airs on Thursday, April 26th, 2012. For more details or to register, please visit our site at www.fxconferences.com

With the explosion of social media has come a significant increase in the level of regulatory scrutiny, making it imperative to put in place policies and practices compliant with applicable laws. This audio conference presentation discusses the rules that apply to social media, and what you need to do to comply with the law, including the FTC endorsement guides.

Our speakers also address the legal and PR issues that arise when marketers, their employees, bloggers, affiliates and spokespersons fail to comply with FTC endorsement guides. The presentation explains why it is so important to have a social media policy, and what should be included in that policy. Lastly, the speakers also discuss what rules apply when conducting a promotion using social media, including Facebook and Twitter.

The Foreign Supplier Verification Program and What It Means for the Food Industry

is being presented by Marc C. Sanchez, Regulatory Counsel, with Contract In-House Counsel and Consultants, LLC and airs on Wednesday, April 25th, 2012. For more details or to register, please visit our site at www.fxconferences.com

The Foreign Supplier Verification Program (FSVP) automatically takes effect in 2013 under the terms of the Food Safety Modernization Act. Congress had set a one-year deadline of January 4, 2012 for the FDA to publish details on how it will regulate imported foods. This includes verifying foreign suppliers, a definition of high-risk foods, and a certification process. While the FDA missed that deadline, it has promised a rule and guidelines soon.

In the meantime, the FSMA makes it clear that the foreign supplier verification program will become mandatory in 2013, whether a rule is in place or not. In this audio conference presentation, our speaker provides an overview of the FSVP, looks at the likely FDA definition of high-risk foods, and what is likely to be the certification process. The presentation also provides advice on how to cope with compliance when the FDA lags behind in rulemaking.

Medical Device Reimbursement in China

is being presented by Seth J. Goldenberg, President, of Asia Pacific Bio Intelligence and airs on Tuesday, April 24th, 2012. For more details, or to register please visit our site at www.fxconferences.com

Medical device and pharmaceutical manufacturers have been facing increasing downward pressure on their products because of pricing regulations in China. It has become increasingly important to not only understand how to get your product through the regulatory approval process in China, but also how to get the price you want in China's rapidly evolving healthcare landscape.

This audio conference presentation provides attendees with an overview of the healthcare system in China, and how imported medical devices are viewed and treated under the Chinese insurance system. Our speaker discusses device reimbursement policies at the local and national levels, and reviews some recent developments in that regard.

Agile Software Development in the Medical Device Industry

is being presented by Janet Balk, Principal, with Agile FDA and airs on Thursday, April 19th, 2012. For more details, or to register please visit our site at www.fxconferences.com

Decreasing development timelines and getting products to market faster benefits both patients and health care providers and is obviously a priority for any company. However, when a medical device company embraces agile software development to accomplish this goal, there are common pitfalls that can be counter-productive and might actually delay getting your product out the door. What's more, introducing agile methodology can create tension between those working in quality, regulatory affairs and R&D. This audio conference presentation demonstrates how to avoid the most common pitfalls, how to ensure compliance with agile development, and how to strengthen the agile process and make it a win-win for departments with differing priorities.

Developing a Sampling Plan for Quality Audits

is being presented by Dan O’Leary, President, of Ombu Enterprises, LLC and airs on Thursday, April 19th, 2012. For more details or to register, please visit our site at www.fxconferences.com

Quality audits typically involve sampling of records and other documents. When the auditor does this a lot of questions come up, such as how many records to sample and how many nonconforming records are too many. In fact, there is a more fundamental question about nonconforming records. If a record has, say, three errors does the auditor count it three times – once for each error – or just once, as a nonconforming record? Some auditors determine the sample size without using statistical techniques. Is this ever acceptable? Sampling records in an audit is not the same as sampling at incoming inspection; the underlying assumptions are different, so the methods need to change.

This audio conference examines the issues in audit sampling and provides the answers you need to plan your audit. Participants learn the difference between counting nonconformities and counting nonconformances and which techniques to apply in a quality audit. An audit may need to determine the error rate in a process, or least show that it is not too great. Attendees learn some standard sampling plans as well the reason they work. As an example, participants will analyze the sampling plans the FDA uses as part of the Quality System Technique (QSIT)

Investigator Brochures for Medical Devices

is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, April 18th, 2012. For more details, or to register please visit our site at www.fxconferences.com

An investigator's brochure (IB) is required for compliance with the EU Medical Device Directives (e.g. 2.7.2) and also with ISO 14155: Clinical Investigations of Medical Devices in Human Subjects – Good Clinical Practices. The development of an IB for medical devices should reflect the engineering features of the device, in much the same way that an IB for pharmaceutical agents reflects the chemical features of the drug. As a dynamic document, the IB must be carefully constructed and, ideally, it should accurately represent the current state of all knowledge about the investigational product – including information about AEs, SAEs, and important manufacturing details as well as nonclinical and clinical study results.

This audio conference presentation provides an overview and best practices for the medical device IB, looking at some of the related issues specific to devices and discussing how the brochure is likely to evolve over time.

Best Practices for Conducting Clinical Trials in Emerging Countries

is being presented by Dr. Nermeen Varawalla, CEO, of ECCRO and airs on Tuesday, April 17th, 2012. For more details or to register, please visit our site at www.fxconferences.com

The value of emerging countries in delivering cost-effective patient recruitment is well documented. However concerns remain about data quality, GCP compliance, extrapolation of trial outcomes and regulatory hurdles. These concerns often can be addressed by combining an understanding of international clinical trial requirements and local expertise.

Our speaker for this event is Dr. Nermeen Varawalla, a reknowned expert on the conduct of clinical studies in emerging markets in general, and India in particular. In this presentation she discusses how to take things one step further by customizing industry best practices for the emerging clinical trial environment. These include the formation of select investigator networks, integrated site management and data-driven, hybrid monitoring. In this presentation, Dr. Varawalla shares case studies highlighting her work in India to illustrate the effectiveness of these practices in overcoming typical concerns about conducting clinical research in emerging countries.

FDA Update – Responding to Unsolicited Requests for Off-Label Information

is being presented by Marian J. Lee & Beverly H. Lorell, Partner & Senior Advisor, with King & Spalding LLP and airs on Thursday, April 12th, 2012. For more details, or to register please visit our site at www.fxconferences.com

FDA recently released a significant draft guidance on how manufacturers and distributors of drugs and medical devices may respond to unsolicited requests for information about off-label uses of their products. This audio conference presentation analyzes the far-reaching implications of that new guidance for company practices and procedures regarding these scientific communications, and also what it means for the use of off-label promotion as the basis for enforcement action by FDA and other federal authorities. Our speakers examine the impact of the agency's newly defined distinctions between solicited and unsolicited requests for information, and non-public and public information requests, including those requests arising in emerging electronic media. The presentation focuses on providing practical tips and pitfalls to avoid in implementing this new draft guidance.

Sample Size for Design Verification and Validation

is being presented by Steven Walfish, Statistician, with GE Healthcare and airs on Wednesday, April 4th, 2012. For more details or to register, please visit our site at www.fxconferences.com

Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process for medical devices to ensure that the completed design that is transferred to production is appropriate for its intended use. The goal of this presentation is to understand the requirements and statistical techniques involved in the design controls process.

This audio conference looks at the types of requirements that lend themselves to statistics in verification and validation. Our speaker also covers the relationship between risk and sample size. Participants gain a fundamental knowledge for determining sample size in statistical testing, while understanding how variance in the population can impact the sample size necessary to establish objective evidence.

Avoiding and Responding to FDA Import Alerts

is being presented by Lisa Capote, Partner, with Arrastia & Capote LLP and airs on Tuesday, April 3rd, 2012. For more details, or to register please visit our site at www.fxconferences.com

When companies, products or geographical regions are added to import alerts, also known as detention without physical examination, you can rest assured you are not getting through the US border without some additional effort on your part. At the point in time one of your products is listed on an import alert the product is automatically detained by FDA with assistance of Customs and Border Protection and it is your obligation to convince FDA that your product complies with the regulations. If the evidence you provide FDA is insufficient to merit release, the product will be refused entry. The process of having the product detained while you plead with FDA for a release can result in increased costs to the importer.

This audio conference presentation provides detail on FDA’s import alert process, and looks at the factors that result in facilities or their products being placed on import alert. Our speaker shares insight on proactive steps you can take to avoid this “blacklist” as well as some best practices to follow to be removed from import alert.

Human Subject Protection Programs - Analyzing the New Proposed Regulations

is being presented by Eric Allen, Director, Office of Research Compliance, with University of North Carolina at Greensboro and airs on Thursday, March 29th, 2012. For more details, or to register please visit our site at www.fxconferences.com

For the first time in more than 20 years, the Office of Human Research Protections is reviewing the federal regulations governing protection of human subjects. It will be the first substantive change to these regulations since 1991, and the potential impact will affect all individuals who are currently involved in human subject research and those who plan to be in the future.

Overall, this is a much-needed document for the human subject research community. There are a few areas in particular that will be improved by this new legislation, such as regularly updated expedited review categories and improved accountability for research as a whole. However, the majority of the changes provide great concern for investigators, IRBs, institutional officials, potential research subjects, and regulatory compliance administrators, as the revisions will drastically alter the way research is conducted, reviewed, and perceived by the general public.

In this audio conference presentation, our speaker analyzes the newly proposed human subject regulations in the context of their current state, highlighting significant changes and pointing out critical concerns and areas that need further clarification.

eLabeling Medical Devices for the EU Market

is being presented by Salma Michor, CEO and Principal Consultant, of Michor Consulting EU and airs on Wednesday, March 28th, 2012. For more details or to register, please visit our site at www.fxconferences.com

Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.

In order to set up an e-labeling system, companies must develop and implement internal controls and procedures that promote adherence to regulatory requirements including applicable statutes, laws, regulations and directives. e-labelling provides several advantages in managing regulatory compliance but also poses some challenges. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling to gain competitive advantage.

Establishing Effective and FDA-Compliant Good Clinical Practices (GCP)

is being presented by Dr. David Lim, Founder, of Regulatory Doctor and airs on Tuesday, March 27th, 2012. For more details, or to register please visit our site at www.fxconferences.com

In the United States, scientific studies designed to develop evidence to support the safety and effectiveness of investigational drugs, biological products and medical devices (including in vitro diagnostic devices) are regulated by the Food and Drug Administration (FDA). Those conducting these clinical studies – such as clinical investigators, sponsors, monitors, and CROs – must comply with the applicable statutes and regulations governing good clinical practice (GCP).

This audio conference presentation is intended to provide attendees with a detailed review and understanding of the FDA regulations applicable for clinical trials or studies, and requirements for compliance. Our speaker drawns upon extensive industry experience and shares insight on the various aspects of GCP, empowering attendees with the key information they need regarding FDA regulations and requirements.

New Paradigm – Drug Development Partnerships and Their Impact on Quality

is being presented by Dr Pete Harpum, Harpum Consulting and airs on Thursday, March 22nd, 2012. For more details or to register, please visit our site at www.fxconferences.com

The focus of work in the drug development industry is inexorably moving away from vertically integrated pharmaceutical and biotechnology companies – the ‘sponsors’ – to contract research organizations (CROs) and other third-party suppliers of services. Approximately 350,000 people have left employment in pharmaceutical and biotechnology companies – but they did not leave the industry. Many of these people moved from the sponsor/client side to the CRO/seller side. Drug development work is now increasingly done by third parties: the challenge facing industry is how to maintain and improve quality of service?

Partnering is a valuable strategy for clients and sellers to work together. In this presentation our speaker draws upon the lessons of other industries in which the majority of work is carried out by third parties in partnership with buyers, and looks at how partnering can facilitate high quality service provision by CROs.

Monitoring Essentials for Medical Device Trials

is being presented by Helen Colquhoun, CEO, Pleiad Inc. and airs on Wednesday, March 21st, 2012. For more details, or to register please visit our site at www.fxconferences.com

Within the past few months, both FDA and ISO have issued updated regulatory guidance relevant to the monitoring of medical device trials. The FDA issued its draft guidance in August 2011, recommending a risk-based approach to monitoring. Meantime, the latest version of the ISO 14155 standard was also issued in 2011. It describes Good Clinical Practice for medical device trials, and it is an international standard, accepted in most countries. It includes guidance on monitoring and, ironically, leans towards a high proportion of on-site monitoring visits to assure data quality.

In this presentation, Dr. Helen Colquhoun provides an overview of the two guidance documents, and shares best practices for monitoring medical device trials. The presentation includes examples of citations in FDA warning letters for failure to monitor medical device studies correctly, in order to identify some common pitfalls during monitoring.

The Revised RoHS Directive and What It Means for Device Manufacturers

is being presented by Dr. Joachim Wilke, Director, Regulatory Affairs & Policy, Europe, with Medtronic and airs on Thursday, March 15th, 2012. For more details or to register, please visit our site at www.fxconferences.com

In July 2011 the EU Commission published the recast Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU which will replace the original RoHS Directive 2002/95/EC. The new Directive has to be transposed into the national laws of EU Member States by January 2, 2013. In contrast to the original version, its scope will include Medical Devices effective July 22, 2014, and therefore RoHS compliance will become one of the major quality and regulatory activities of medical device manufacturers during the upcoming months.

This audio conference presentation summarizes the requirements of Directive 2011/65/EU with particular attention to its scope and exemptions. Our speaker also explains the responsibilities of manufacturers and distributors. According to the Directive, RoHS compliance must be demonstrated by a Declaration of Conformity and by affixing a CE mark to the device. As a matter of fact, the Medical Device Directive 93/42/EEC CE mark, which includes the Notified Body identification number, will cover RoHS compliance in the future as well. Accordingly, this presentation covers questions related to Notified Body Quality Management auditing including Technical File and Declaration of Conformity review.

Improving Study Feasibility- Why Sites Fail and How to Avoid It

is being presented by Nikki Christison, President, of Clinical Resolutions and airs on Wednesday, March 14th, 2012. For more details or to register, please visit our site at www.fxconferences.com

Only 7% of selected sites meet their enrollment targets. Millions of dollars are spent rescuing studies through amendments, adding more sites, and increasing advertising funds. The simple fix would be to select the “right” sites; however, if it was that easy everyone would be doing it.

Site selection should be viewed as a two-way street, with both sponsors and sites taking ownership for the process. Sponsors often provide limited information to sites during the selection process, and then establish unrealistic expectations once the sites agree to do the study. Meantime, sites are eager to get studies to support their patients, reputations and budgets, but are also afraid to say “no” in case they miss out on a future opportunity.

This audio conference presentation looks at the root causes of feasibility assessment failures, discussing the responsibilities of sites and sponsors during the feasibility process, and providing recommendations for “fixing” the feasibility assessment process for both the sponsor and site.

Industry Update – China's Evolving Medical Device Regulations

is being presented by Seth J. Goldenberg, President, of Asia Pacific Bio Intelligence and airs on Tuesday, March 13th, 2012. For more details, or to register please visit our site at www.fxconferences.com

China is constantly improving its regulatory statutes and bringing them in line with other international regulatory bodies, and 2011 was a banner year for regulatory updates from China’s State Food and Drug Administration (SFDA). Significantly, the SFDA started its scheduled enforcement of medical device good manufacturing practices (GMP) regulations, and it also issued new rules that increase oversight of medical device adverse events and recalls. The device approval process was also modified to ease registration by not requiring clinical trial data from companies domestically producing Class II devices, which is very similar to the U.S. FDA 510k process. These changes will have broad implications in the short and long term for domestic Chinese firms and multinational firms already in or considering entry into China.

This audio conference presentation provides an update on various aspects of China's medical device regulations, focusing on recent changes and exploring what they mean for device manufacturers.

Post-market Design Changes – What FDA is Saying Now

is being presented by David Rothkopf, President, of MEDIcept and airs on Tuesday, March 13th, 2012. For more details or to register, please visit our site at www.fxconferences.com

Many companies make subtle changes to their devices over time. However, those subtle changes can add up to the point where the current design no longer matches the product deemed safe and effective by the FDA. Whether you just received clearance for your product or it was last cleared in the last century, the FDA has stepped up enforcement on modifications to devices without notification. During site investigations, the FDA is looking at design changes and reviewing all the changes between now and when you last received a 510(k) clearance.

In July 2011 the FDA released a draft guidance document on 510(k) device modification and when to submit a new 510(k) for an existing device. This document reflects the current thinking of the FDA, and will replace the present guidance released in 1997. Are you ready? Do you know the configuration of your product when it was last cleared? Those “letter to file” changes might no longer be acceptable. This audio conference presentation reviews the new guidance document, looks at how to perform a design gap analysis on a device, and discusses what to do when you realize you probably should submit a new 510(k).

FDA Update – Responding to Unsolicited Requests for Off-Label Information

is being presented by Marian J. Lee & Dr. Beverly H. Lorell, Partner & Senior Medical and Policy Advisor, with King & Spalding LLP and airs on Thursday, March 8th, 2012. For more details, or to register please visit our site at www.fxconferences.com

FDA recently released a significant draft guidance on how manufacturers and distributors of drugs and medical devices may respond to unsolicited requests for information about off-label uses of their products. This audio conference presentation analyzes the far-reaching implications of that new guidance for company practices and procedures regarding these scientific communications, and also what it means for the use of off-label promotion as the basis for enforcement action by FDA and other federal authorities. Our speakers examine the impact of the agency's newly defined distinctions between solicited and unsolicited requests for information, and non-public and public information requests, including those requests arising in emerging electronic media. The presentation focuses on providing practical tips and pitfalls to avoid in implementing this new draft guidance.

Writing Web Content That Works

is being presented by Janice Redish, President, of Redish & Associates, Inc and airs on Wednesday, March 7th, 2012. For more details or to register, please visit our site at www.fxconferences.com

People come to websites for the content. They come to fulfill a need, to do a task, to get the answer to a question. Clear navigation, good design, and search engines that work are all critical, of course, but they are all there to support the content. Are you paying enough attention to the content on your website – both to what your messages are and to how you are presenting those messages? In this audio conference presentation, reknowned speaker and author Ginny Redish teaches attendees to think about web content and web writing in new ways. Starting from the premise that every visit to your website is a conversation started by the site visitor, the presentation demonstrates for attendees why people skim and scan, provides a better understanding of when people do read online and when they don't, and reviews a few basic best practices on how to write for the busy people who come to your website.

Conducting Medical Device Studies in the UK

is being presented by Janette Benaddi, CEO, of Medvance and airs on Tuesday, March 6th, 2012. For more details, or to register please visit our site at www.fxconferences.com

The MHRA has been making a concentrated effort to streamline its approval process, and thereby to encourage medical device research in the UK. Among the recent changes, Research Ethics Committees (REC) now have special medical device committees, and the guidance governing submission of device applications to REC is being updated. A new Health Research Authority hs been established. The MHRA and RECs have integrated their application systems, and it will soon move to a new, unified portal. The list of changes is lengthy, and it should add up to a regulatory environment more conducive to device research. However, there are still key points to consider, and things you can do to make the regulatory journey as painless as possible.

This audio conference presentation provides attendees with the information they need to conduct successful studies in the UK, reviewing recent changes in the regulatory landscape and examining what they mean for device companies. Our speaker draws upon extensive experience, and shares tips for navigating through the approval processes quickly and efficiently, ensuring a timely start to studies in the UK.

Early Development Considerations for Inhalation Drug Products

is being presented by Dr. Nahed Mohsen, Biomedical Engineering Consultant and airs on Thursday, March 1st, 2012. For more details, or to register please visit our site at www.fxconferences.com

Inhalation drug products are delivered via the lungs by aerosol delivery devices, and are used to deliver therapies to treat local and systemic diseases. The advantages of these products are ease of use and the small doses required to achieve the desired treatment. However, the required dose and efficacy of delivery is highly dependent on various developmental design factors which may not be readily apparent. These include drug formulation, aerosol delivery system, interaction between the formulation and the delivery system, packaging of formulation and delivery system as well as human maneuvering with the delivery system – known as hand-lung coordination. Although an inhalation drug product may be comprised of an approved drug and an approved device, new scientific and technical issues may emerge when the drug and device are combined, packaged or used together.

In this audio conference presentation, our speaker draws upon a case study involving a dry powder drug product to address the scientific and technical challenges raised by inhalation drug product packaging, including selection of the component of the primary packaging and how it affects product performance, safety, effectiveness, and quality of the combination product.

An Overview of Recent Risk-based Monitoring Guidance from the FDA

is being presented by Dr. Joy Frestedt, Frestedt Incorporated and airs on Wednesday, February 29th, 2012. For more details, or to register please visit our site at www.fxconferences.com

We have been waiting for an update on the FDA guidance on monitoring since 1988, and that update is finally here! This presentation reviews three FDA recent guidance documents about monitoring. Our speaker discusses the information provided in the 'Compliance Program Guidance Manual' for BIMO inspectors 'CHAPTER 48 – Bioresearch Monitoring' (CPGM 7348.810 for sponsors, CROs and monitors and CPGM 7348.811 for clinical investigators and sponsor-investigators) for foods, biologics, drugs and devices, which was implemented in March of 2011. The presentation also reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data.

These documents are designed to clearly articulate alternative practices for a “modern, risk-based approach” to monitoring, and attendees of this audio conference gain valuable insight on the changes, and the resulting opportunity to change the way monitoring is done in efforts to improve attention to human subject protection and high quality data.

Measuring and Improving the Readability of Medical Device User Information

is being presented by Cynthia M. Shalers, Writing, Editing & Design Consultant and airs on Tuesday, February 28th, 2012. For more details or to register, please visit our site at www.fxconferences.com

A concise, clearly written, readable user guide can mean the difference between a successful, happy customer and a frustrated, angry, or even endangered one. This audio conference approaches readability in medical-device documentation from two directions. First, our speaker explains how to achieve the reading level required by the FDA, providing attendees with the tools for measuring the reading level and adjusting it editorially. Second, she offers a variety of methods for increasing conciseness and simplicity in medical writing, which can be applied to any level of complexity to improve readability. The presentation also reviews graphical aspects that improve readability, such as the proper use of white space, leading, lists, and sidebars. Throughout the conference, the speaker uses specific examples from her own work and cites the relevant FDA guidance documents.

Food Industry Update – Responding to an FDA Form 483

is being presented by Lisa Capote, Partner, with Arrastia & Capote LLP and airs on Thursday, February 23rd, 2012. For more details or to register, please visit our site at www.fxconferences.com

On January 4, 2011 President Obama signed into law the FDA Food Safety Modernization Act (FSMA). As part of the new regulation, FDA will provide oversight, ensure compliance with requirements and respond effectively when problems emerge. The FSMA mandates inspection frequency based on risk for food facilities, and requires the frequency of inspections to increase immediately. The law directs FDA to inspect at least 600 foreign food facilities within one year of enactment, and double those inspections every year for the next five years. Odds are, that will in turn lead to the issuance of a great deal of additional Form 483s to companies that have never before seen one, let alone had to respond to one.

This audio conference presentation provides detail on the FDA's plans for increased facility inspections, and looks at the most likely areas of scrutiny for inspectors in the coming months. Our speaker shares insight on the steps you can take to ensure a successful inspection, and, in the event your company receives a Form 483, how best to respond so as to avoid a re-inspection.

Monitoring Device Trials: Findings, Recommendations, Corrective Action Plans

is being presented by JoAnn Tyson, CEO & Senior Clinical and Regulatory Affairs Director, with J. Tyson & Associates and airs on Wednesday, February 22nd, 2012. For more details or to register, please visit our site at www.fxconferences.com

Monitoring for a medical device trial can present unique challenges related to the complexity of the protocol, data capture tools, site personnel selection and limited oversight of subjects/data or procedures inconsistent with good clinical practices (GCP). However, proper monitoring can allow the sponsor/CRO to identify risks more readily and more clearly.

This audio conference presentation focuses on best practices for monitoring medical device trials, from the essential areas of focus during interim site visits to the proper training of monitors and other clinical personnel to ensure trial objectives are achieved. Our speaker also discusses compliance requirements and corrective action plans, and reviews the necessary steps in preparing for a successful regulatory body inspection.

Meeting the Linguistic Requirements for EMA Submissions

is being presented by Anabel Pérez, Senior Project Manager, with ForeignExchange Translations and airs on Tuesday, February 21st, 2012. For more details, or to register please visit our site at www.fxconferences.com

Translating product information documents in preparation for an EMA submission can be a frustrating, complex and lengthy process for both pharmaceutical companies and their translation providers. However, by establishing and maintaining communication from the start of the project, and by working together to establish realistic timelines and achievable milestones, many of the common headaches can be avoided.

In this audio conference presentation, our speaker outlines the pain points often encountered when translating for an EMA submission, and proposes solutions, innovations and best practices that will allow client and supplier to work together collaboratively to meet all the EMA requirements, and make for a smoother submission.

Turning Technical Experts into Great Leaders

is being presented by Leigh Bailey, Founder & CEO, of The Bailey Group and airs on Thursday, February 16th, 2012. For more details or to register, please visit our site at www.fxconferences.com

Technical leaders can be defined as those who are experts in a particular specialty (e.g. engineering, nursing, medicine, finance, law, or accounting), and whose career paths have changed from a technical/individual contributor track to a management track. In many cases, they are promoted to management because of their success as individual contributors – partly as a reward for their history of good work and partly because it is assumed they will teach their direct reports to be as gifted as they are at their technical specialty.

In such situations, it does not take long for problems to arise with newly appointed managers. Direct reports often claim that the new manager is a “micro manager” and they cannot do their work well enough to earn his or her praise. Peers may complain that the new manager is condescending, doesn’t listen, or jumps to false conclusions. Most damaging is when the new manager does not think anything is wrong and dismisses the feedback from his or her colleagues. Left unchecked, these situations often lead to the boss deciding that the “collateral damage” created by these new managers is too great and they are returned to their individual contributor role, ego and reputation badly damaged.

These kinds of situations are entirely avoidable, and this presentation looks at how to identify good candidates for technical leadership, how to spot individuals who are less likely to succeed, and how to work with existing technical leaders to maximize their chances for success.

The De Novo Petition – Is There Hope at FDA for Lower Risk, Innovative Devices?

is being presented by Michael A. Swit, Principal, with Law Offices of Michael A. Swit and airs on Wednesday, February 15th, 2012. For more details, or to register please visit our site at www.fxconferences.com

The 'de novo' 510(k) petition process presents a unique opportunity for medical device companies to bring products to the market without having to go through the more lengthy and expensive route of a Premarket Approval Application (PMA).

In 1997, recognizing that many innovative devices put into Class III presented lower risks, Congress revised the medical device laws to create the de novo petition. It allows a company to petition FDA to move a device that has been automatically classified into Class III to Class II or even Class I. While designed to relieve the regulatory burden on industry, the de novo petition process has presented many challenges. Less than 70 devices have successfully undergone the de novo process. And, the process is not easy. Before pursuing a petition, a firm must first file a 510(k) and have FDA deny the submission as not substantially equivalent.

In late 2011, FDA issued a new draft guidance on the de novo process, and legislation is pending that would streamline the system. This audio conference explores how to take advantage of the de novo process, challenges linked to the process and how to best position your petition for success.

The Food Safety Modernization Act – What It Really Means (And What It Doesn't)

is being presented by Benjamin L England, Founder and CEO, of FDAImports.com and airs on Wednesday, February 15th, 2012. For more details or to register, please visit our site at www.fxconferences.com

Since its introduction, the Food Safety Modernization Act has been discussed, written about and portrayed ad infinitum, often out of any sensible context to the actual realities of importing and manufacturing. Hyperbole aside, what does it really mean for you and your company?

With this timely audio conference presentation, former FDA veteran Benjamin England brings a much-needed reality check to the FSMA conversation. The presentation looks at what FSMA implementation this year will likely consist of, and what specific issues are likely to arise based on these new rules in a real-world context. For manufacturers, companies and distributors this means valuable insight into which changes should be of concern, what can safely be ignored, what they can expect in the coming months, and how best to prepare. Mr. England devotes special attention to the implementation dates for 2012, and provides attendees with an opportunity to ask questions specific to their situation.

Who Owns What? Patent Ownership Issues with the Exchange of Biotechnology

is being presented by Kattina V. Barsik, Esq. Intellectual Property and Registered Patent Attorney and airs on Tuesday, February 14th, 2012. For more details, or to register please visit our site at www.fxconferences.com

Institutions involved in the exchange of unique materials – including federal laboratories, industrial research laboratories, and laboratories in universities, hospitals, or independent research institutes – often have specific expectations regarding compensation for the help they provide. It may range from acknowledgment in a publication to ownership of inventions made with the aid of the provided material.

Industry defends its commercial interests vigorously, and seeks to offset risk by acquiring and protecting exclusivity in the marketplace through patent law or by use of trade secrets. In contrast, the federal government and its academic grantees look to preserve the flow of ideas for public benefit, primarily through timely publication, and to serve as the public's steward of inventions by preserving the potential for new knowledge to generate a product from which the public may benefit. The exchange of materials between universities and industrial laboratories is often difficult, and unlikely to be standardized in the near future.

This audio conference presentation discusses how to deal with these competing priorities, and craft terms which avoid conflict and allow all parties to benefit.

The UK Bribery Act– Upping the Ante on Anti-Corruption/Anti-Bribery Enforcement

is being presented by Jamie L. Kendall, Esq., Senior Director, with Compliance Implementation Services and airs on Thursday, February 9th, 2012. For more details or to register, please visit our site at www.fxconferences.com

Since 1977, international pharmaceutical manufacturers have had to ensure their local affiliates abide by the Foreign Corrupt Practices Act (FCPA) when interacting with government officials. Just this past April, Johnson & Johnson came to settlement terms with the SEC for FCPA charges to the tune of $48.6 million stemming from allegations of bribing and providing kickbacks to public doctors in Europe and Iraq.

In 2010, the United Kingdom threw its hat into the anti-corruption/anti-bribery ring by enacting the UK Bribery Act, which went into effect July 1, 2011. In an interview with the Daily Telegraph the day it went into effect, the director of the UK Serious Fraud Office emphasized the intention to use the UK Bribery Act to go after non-UK corporations. While most companies may be familiar with best practices to avoid criminal investigations and civil penalties under the FCPA, the UK Bribery Act creates an additional layer of scope and raises the floor of compliance by including parties and actions not contemplated by the FCPA.

Pharmaceutical companies with UK connections will no longer be able to rely on anti-corruption policies and procedures that were predicated solely on FCPA compliance. Indeed, such policies and procedures must now account for the wider net that the UK Bribery Act casts. The enactment of the UK Bribery Act increases fraud and abuse risk exposure and an understanding of its provisions and how it differs from the FCPA is essential for creating a comprehensive compliance policy.

This presentation provides attendees with an overview of the differences between the UK Bribery Act and the FCPA and emphasizes the wider scope the UK Bribery Act represents in the anti-corruption/anti-bribery regulatory and legal framework.

Patient Recruitment: How It's Broken and Five Ways to Fix It

is being presented by Sherry Reuter, President, of Sherry Reuter & Associates and airs on Wednesday, February 8th, 2012. For more details, or to register please visit our site at www.fxconferences.com

The numbers don't lie: clinical trial enrollment rates have dropped from 75% in 2000 to 59% in 2006 and retention rates have fallen from 69% to 48% during same period; delays in patient recruitment for clinical trials account for an average of 4.6 months lost per trial – an annual cumulative loss of 26 years, on average, for each company; 80% of total trials are delayed at least one month because of unfulfilled enrollment.

The bottom line? Patient recruitment as we know it just isn't working.

This audio conference presentation looks at the efforts currently used to reach recruitment goals, why they are ineffective, and why new approaches must be implemented. Our speaker shares specific strategies that can be easily implemented, and helps attendees understand the patient's perspective and how to use that awareness to make recruitment plans more effective.

Medical Device Software – Regulatory Requirements and Issues

is being presented by Neil R. Armstrong, CEO, of MeddiQuest and airs on Tuesday, February 7th, 2012. For more details, or to register please visit our site at www.fxconferences.com

Healthcare is being revolutionized through the synergistic development of information technology and medical devices, and regulators are starting to realize that healthcare software cannot be ignored or adequately regulated by analogy to hardware alone. However, there is little consistency in the extent or content of new regulations being introduced.

This audio conference presentation is targeted at those involved in developing medical devices with software, or software to be used in a healthcare environment, who want a high-level overview of the regulatory landscape and a better understanding of current issues. Our speaker discusses the evolution of medical device software regulations, summarizing the current regulatory requirements in major markets. We also explore some forthcoming issues, and how current product development can be “future-proofed” against new regulations.

Improving Compliance and Patient Safety with Plain Language Authoring

is being presented by Kristina E. Anderson, EasyRead Writing LLC and airs on Wednesday, February 1st, 2012. For more details, or to register please visit our site at www.fxconferences.com

The Plain Writing Act of 2010 is the latest government effort to make complicated regulations easier to read and understand. "Plain language" refers to a method of authoring documentation in a straightforward, sensible, engaging and culturally appropriate manner. It makes the complicated easier to grasp. It tells readers what they need to know and nothing else. When done correctly, it ensures understanding and compliance and improves patient safety – and now it's the law! What plain language is not, is the "dumbing down" of information.

Authoring your documentation using plain language can result in a savings of both time and money by reducing mistakes and misunderstandings. However, successful implementation requires buy-in on an organization-wide level, and there can be some resistance to change. This audio conference presentation is designed to provide attendees with an understanding of what plain language is, how and why to start using it, and what the Plain Writing Act of 2010 means for your company. It also provides regulatory writers with the compelling information they need to convince managers that plain language authoring is a valid and necessary development in health care.

7 Critical FDA Expectations of Senior Management

is being presented by John Avellanet, Managing Director & Principal, with Cerulean Associates LLC and airs on Tuesday, January 31st, 2012. For more details or to register, please visit our site at www.fxconferences.com

The FDA is cracking down on corporate executives, using the Park Doctrine and the FDAAA to impose civil penalties, jail time and industry bans.

This audio conference presentation focuses on the things your management team needs to be doing on a regular, consistent basis to 'ensure the suitability and effectiveness' of your company's quality system. Our speaker, who is president of an independent review organization (IRO) for a current consent decree, provides insight on what FDA investigators and district officers expect to see from your management team. Attendees discover the crucial difference in the eyes of FDA between responsibility and accountability, and how it affects delegating work to staff and suppliers. The presentation also discusses how to ensure your management team is effectively and appropriately engaged, and what proof you need to provide the agency investigators.

Preparing for 2012: Regulatory Update for Device & Diagnostic Companies

is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Tuesday, January 31st, 2012. For more details, or to register please visit our site at www.fxconferences.com

2011 was quite a year for publishing proposed major changes to the regulatory framework for medical device and diagnostics manufacturers. It is likely that more certainty will be introduced during 2012 as to what the changes will be and how they will affect MD&D companies. The major topics include the 510K process in the US, the planned recast of the Medical Device Directives in the EU, potential changes to the informed consent process for sample collection in the US, planned changes to the monitoring guidance in the US, and the changes to the ISO 14155 standard issued in 2011.

In this audio conference, our speaker reviews the changes or proposed changes to the regulatory framework, discusses the implications for MD&D companies, and describe how best to plan for future changes. The presentation also provides pointers on when the changes currently in draft form are likely to be implemented. This audio conference is intended to summarize the 2011 regulatory landscape for MD&D companies, and help them prepare for 2012 and beyond.

Food Defense – Regulatory Requirements and New Developments

is being presented by William L Ramsey, Director of Security, with McCormick & Company and airs on Thursday, January 26th, 2012. For more details or to register, please visit our site at www.fxconferences.com

The safety and security of the food supply has come under intense scrutiny in the wake of 9/11. In the intervening years "food defense" has become an industry catchphrase. But what exactly does it mean? What do regulators want to see?

This audio conference presentation reviews the use of physical security practices in the food industry since the events of September 11, 2001 and the advent of the term “food defense”. Our speaker discusses current food defense expectations from both the USDA and FDA, and takes a look at some possible regulatory developments associated with the Food Safety Modernization Act of 2010.

The presentation provides key information on the use of threat assessments, vulnerability assessments and risk assessments, as well as the use of a “goal based” security model in the development of security and food defense plans for food manufacturing facilities. Attendees also learn about supply chain responsibilities, and ways to utilize national and international supply chain programs such as C-TPAT, AEO and PIP to enhance food defense measures.

An Overview of Recent Risk-based Monitoring Guidance from the FDA

is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, January 25th, 2012. For more details, or to register please visit our site at www.fxconferences.com

We have been waiting for an update on the FDA guidance on monitoring since 1988, and that update is finally here! This presentation reviews three FDA recent guidance documents about monitoring. Our speaker discusses the information provided in the 'Compliance Program Guidance Manual' for BIMO inspectors 'CHAPTER 48 – Bioresearch Monitoring' (CPGM 7348.810 for sponsors, CROs and monitors and CPGM 7348.811 for clinical investigators and sponsor-investigators) for foods, biologics, drugs and devices, which was implemented in March of 2011. The presentation also reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data.

These documents are designed to clearly articulate alternative practices for a “modern, risk-based approach” to monitoring, and attendees of this audio conference gain valuable insight on the changes, and the resulting opportunity to change the way monitoring is done in efforts to improve attention to human subject protection and high quality data.

Collecting Post-Market Device Data Without Running Afoul of FDA

is being presented by Robert J. Klepinski, Regulatory Attorney, with Fredrikson & Byron and airs on Thursday, January 19th, 2012. For more details, or to register please visit our site at www.fxconferences.com

Most medical device companies today wish to gather data on product use and performance without being entangled in expensive IDE negotiations. However, recent FDA enforcement actions have brought new scrutiny to post-market studies. FDA has combined accusations of off-label promotion with enforcement against studies collecting data on usage deemed to be outside cleared labeling. So what are device manufacturers to do? Is there still a path available for collecting this important information? This audio conference explores the regulations involved, recent enforcement actions by FDA, the difficulties in ascertaining the scope of indications today, and ways to gather information within the current enforcement environment.

Voice of the Customer: The First Step in Human Factors Engineering

is being presented by Maria Shepherd, Principal, with Data Decision Group and airs on Tuesday, January 17th, 2012. For more details, or to register please visit our site at www.fxconferences.com

The medical device industry faces a unique challenge; R&D professionals develop products but rarely get a chance to use them, while quality departments lack the data to translate customer needs and marketing specifications into technical requirements and metrics. To compound the issue, FDA will soon have its final HFE Guidance in place, and all device products and companies will have to comply.

Voice of the Customer (VOC) allows device manufacturers to immerse product design teams in the customer’s culture and environment, and this audio conference presentation looks at how to use the VOC process to collect and analyze customer data and integrate it into the design process. Attendees learn how to develop market surveys and other tools to assess the needs of customers, and how to define and categorize customer issues with products. Our speaker discusses the relationship between VOC and HFE principles, and shares critical techniques for new product and product improvement initiatives.