Registering Device Trials on ClinicalTrials.gov

It has been a full year since Title VIII of the Food and Drug Administration Amendments Act of 2007 expanded the scope of information that must be registered in ClinicalTrials.gov. Along with mandating the inclusion of medical device trials, additional requirements included increasing the amount of trial information, requiring results, and setting penalties for noncompliance.

One year later, the medical device community still has a lot of questions about requirements and responsibilities to comply with Title VIII, and the FDA is working to provide the answers and guidance.

In this audio conference, you will learn the latest information on registration of medical device trials and what you must do for compliance.

Registering Device Trials on ClinicalTrials.gov was presented by Amy Wise, Manager of Clinical Research, with PharmaNet and aired on 2008-11-13. For more details, or to download this event please visit our site at www.fxconferences.com

Managing Global Market Research for Consistency and Insight

Medical companies are increasingly sponsoring global research projects – but is this research effective? How can cultural and linguistic differences be managed to ensure the integrity of the result? Are differences between cultures just skin deep or do they extend to personality? How can we create research metrics that will have consistent meaning around the world? In this Webinar we will provide understanding of these issues and tools for managing global research projects.

Managing Global Market Research for Consistency and Insight was presented by Peter Simpson, President, of Segmedica and aired on 2008-11-12. For more details or to download this event, please visit our site at www.fxconferences.com

Industry Update: EU Labeling for Medical Devices

Many companies believe that by simply having the CE mark on their products they are in position do business in Europe. However, things are not always that straightforward. They tend to forget that the European Union is made up of 27 separate countries (Bulgaria and Romania being the newest members) and underestimate the complexity of dealing with national language requirements. Will Germany allow English labeling for devices used only by a professional? Does Belgium require Dutch, French or German -- or all three?

This audio conference discusses these issues and also cover the use of symbols in packaging, instructions for use (IFU) and device labels. In addition, the presentation covers proper language for the intended users in conjunction with risk management.

Industry Update: EU Labeling for Medical Devices was presented by Dr. Jaap Laufer, Vice President, Public & Regulatory Affairs, with Emergo Group and aired on 2009-03-12. For more details or to download this event, please visit our site at www.fxconferences.com

Device Design in the Current Regulatory Climate

The current regulatory environment is dominated by post-market issues. Recent high-profile drug recalls have caused physician groups, Congress, the press and FDA to take new interest in post-market issues. To survive and prosper in this environment, medical device designers must recognize and accept several key truths.

Unlike drug molecular design, device design is an evolving process, not a one-time event. Also, a medical device is not just hardware, as the product labeling determines its use and its regulatory status. The associated service and customer care can make the difference between success and failure. Therefore, each post-market event causes you to look back into your design process; how far back and in what detail to do so are the key process issues.

This presentation discusses the increase in post-market scrutiny, how it came about, and how device designers can best deal with it.

Device Design in the Current Regulatory Climate was presented by Robert J. Klepinski, with Fredrikson & Byron and is previously recorded. For more details, or to download this event please visit our site at www.fxconferences.com

Conducting Drug Trials in Central & Eastern Europe

Over the next several months, ForeignExchange will present a series of audio conferences featuring expert speakers from Covance discussing the key benefits and drawbacks of using non-traditional sites for conducting clinical research.

In this first first presentation, we focus on the opportunities present in Central and Eastern Europe. This presentation will highlight the current status of the health care system in this region, and how it creates a propitious environment for clinical research business development, boasting rapid recruitment and high quality data.

Conducting Drug Trials in Central & Eastern Europe was presented by Dr. Malgorzata Szerszeniewska, Director of Strategic Development, Central & Eastern Europe, with Covance and is previously recorded. To download this event, or for more details please visit our site at www.fxconferences.com

Design and Regulatory Considerations in Anti-Infective Drug Development

The current regulatory environment in anti-infective drug development is changing due to updates in submission requirements as well as the potential for risk mitigation strategies post-launch. Conversely, the need to develop drugs with acceptable risk/benefit profiles for emerging and re-emerging infectious diseases is certainly present considering the rising concerns of disease due to drug-resistant pathogens, biothreat agents and novel influenza strains.

In this conference our speakers review some of the basic principles surrounding anti-infective drug development in the framework of regulatory submissions. They also provide an update on some of the most important changes in recent years related to specific anti-infective indications.

Design and Regulatory Considerations in Anti-Infective Drug Development is being presented by Dr. John Powers, George Washington University School of Medicine & Dr. Carl Kraus, PRA International and airs on Wednesday, December 16, 2009. For more details or to register, please visit our site at www.fxconferences.com

Friday special - save 75% on "Considering Human Factors in Designing Medical Device Trials"

Increasingly, FDA is requiring that clinical evaluations take into account human factors and their effects on device design. It is becoming more important to address how these affect the safety, performance and reliability of medical device use to ensure appropriate device design.

Evaluating the human interface in the user environment produces critical data for pre-market applications to FDA. However, medical device trials intending to collect these unique data must be carefully designed to bring the most valuable data to light.

In this audio conference the speaker looks at various human factors which must be taken into consideration when designing a medical device clinical trial, and uses a series of real-life examples to illustrate how best to incorporate them into the design process. In addition, all attendees will receive a copy of Pleiad's Human Factors Considerations checklist.

But hurry! If you purchase Considering Human Factors in Designing Medical Device Trials by November 26, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.

Clinical Investigations in Asia

Managing clinical studies in Asia can be both rewarding and challenging, as researchers face such issues as language, regulatory requirements and logistics. However, delays and frustrations can also arise if local practices -- such as standard treatments, insurance and reimbursement, indemnification of sites and investigators, and administration of study grants -- are not considered and anticipated. In addition to a well-structured feasibility study which provides meaningful information and data, the unique considerations of "locality" and corresponding solutions would be of value.

Whether or not a sponsor engages a CRO for Asian studies, it is important that they thoroughly understand the differences, the uniqueness (what and why things are done the way they are in Asia), and the latest on the local regulatory fronts, in order to assemble a solid and achievable clinical management plan.

Focused on China, Taiwan, Hong Kong, South Korea, Japan, Thailand and Singapore, this presentation draws on the benefits and challenges of managing clinical trials in Asia, based on recent experiences. The speaker also addresses critical points to ensure successful project start-up and conduct.

Clinical Investigations in Asia was presented by Edward C. Ian, Director of Operations in Asia, with PRA International and is previously recorded. For more details or to download this event, please visit our site at www.fxconferences.com

ForeignExchange Translations provides specialized Korean, Japanese, and Chinese translation services to medical device and pharmaceutical companies.

Building Better Business Relationships

Relationships are fundamentally critical to business success. However, most individuals and organizations lack the number, quality and level of relationships to achieve their goals and have no effective way to address this critical problem. With the right mindset, process, skills and best practices, individuals and organizations can dramatically improve the productivity and speed at which they build business relationships and achieve critical business outcomes. In this high-energy session, you learn to apply proven techniques that will help you rapidly develop, deepen and manage the relationships that are most important to your success.

Building Better Business Relationships was presented by Dr. Jeff Kaplan, Director of Leadership Development & Training, with Ferrazzi Greenlight and aired on 2009-04-02. For more details or to download this event, please visit our site at www.fxconferences.com

Adaptive Clinical Trials: How Advanced Adaptive Methods Can Improve Your Next Study

Adaptive methods are increasingly used for statistical issues in research, but this limited use overlooks the most powerful and sustained advantages: application of the same adaptive principles to how a study is run. This approach focuses on continuous measurement and refinement of key study metrics that include rapid enrollment, reduced waste, lowering monitoring costs, and quick study conclusion and database lock. Compared to traditional approaches, adaptive methods typically enable 20% faster enrollment, 20-80% lower study query rates, 20-60% lower monitoring costs, and 50% faster database locks.

This audio conference will discuss the tools and processes essential to this approach, along with design and planning issues and net financial impact on Net Present Value and Internal Rate of Return.

Adaptive Clinical Trials: How Advanced Adaptive Methods Can Improve Your Next Study was presented by Michael Rosenberg, M.D., Ph. D., CEO, with Health Decisions and aired on 2009-02-18. For more details or to download this event, please visit our site at www.fxconferences.com

FDA's New Enforcement Strategy: The Growing Perils of Inadequate Compliance

On August 6th, FDA Commissioner Margaret Hamburg outlined the agency’s new enforcement strategy and her plan for creating “a strong FDA.” With greater scrutiny and a more streamlined enforcement process, it is critical that firms be prepared to respond and take corrective action quickly upon receiving a warning letter. This audio conference is designed to help senior life science executives understand what the new strategy means to them, how to maximize the chances that an FDA inspection will not trigger additional agency enforcement action and, if it does, how to respond.

FDA's New Enforcement Strategy: The Growing Perils of Inadequate Compliance is being presented by Matthew Weinberg & Michael Swit, CEO & Vice President, with The Weinberg Group and airs on Wednesday, December 9, 2009. For more details or to register, please visit our site at www.fxconferences.com

Friday special - save 75% on "Device e-Labeling & Regulatory Compliance in the EU"

Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. Currently, most Instructions for Use are provided in paper format, which can be very lengthy.

The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. This is especially the case with IVDs, since these are usually used by healthcare professionals in a clinical environment, with relatively common access to computers and Internet facilities.

However, the latest revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce an amendment to an annex of the directives that will be pivotal for e-labeling, and also for Class IIb and Class III devices. 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.

But hurry! If you purchase Device e-Labeling & Regulatory Compliance in the EU" by November 19, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.

How to Mark & Label Devices Under IEC60601-1 3rd Edition

Get up to speed on the latest requirements incorporated into the 3rd Edition of IEC 60601-1 and take the guesswork out of marking and labeling your medical devices!

Marking and labeling is just one area to tackle in the complicated development of medical devices, but it is a critical one to understand. How do you make sense of all those regulations? It’s challenging enough preparing and testing the device; then you have to worry about the user manuals, screen prompts and packaging too.

In this audio conference, Leo Eisner guides you through each new, added or modified regulation incorporated into the most recent revision of IEC 60601-1. The third edition of this cornerstone standard for medical electrical devices sees major changes from the second edition, changes you need to know about for successful compliance. Ease your marking and labeling stress with detailed guidance from a leading expert.

How to Mark & Label Devices Under IEC60601-1 3rd Edition is being presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and airs on Wednesday, November 18, 2009. For more details or to register, please visit our site at www.fxconferences.com

The Art and Science of Drug Product Regulatory Submissions

Collectively, pharmaceutical drug products include a surprisingly wide variety of possible dosage forms and functions. No matter the dosage form, there are requirements that must be met in manufacturing and testing. A high-quality, organized CMC submission should be organized based on the CTD format, and contain information that will aid in a positive review and a quality drug product for patients. Fortunately, there are many similarities across this wide variety of dosage forms, including general product development principles which can be utilized throughout the life of any drug product.

This session provides an overview of the similarities -- and some unique differences -- of manufacturing, analysis and regulatory expectations. Our speaker explains how these similarities can fit together to produce a high-quality submission to the FDA for marketing approval, as well as regulatory maintenance after approval.

The Art and Science of Drug Product Regulatory Submissions is being presented by Dr. Andrew Trammel, Director, Executive Consultant, with Beckloff Associates and airs on Tuesday, December 8, 2009. For more details or to register, please visit our site at www.fxconferences.com

Stay in the Game: Leading Pharma and Biotech Teams in Tough Times

What do you want others to say of your leadership during these challenging times? When the going gets tough, thanks to conditions such as dropping revenues and profits, mergers and acquisitions, re-organizations or shrinking pipelines, there is an opportunity for leaders to step up and stand out. It is also a time to step back for a little self-reflection on just what are the leadership requirements for this “new normal” of organizational life.

Based on over 20 years of experience working with such companies as Pfizer, Sanofi-Aventis, Biogen Idec and Boehringer Ingelheim, in both research and commercial divisions around the world, Lynda McDermott provides attendees with “best practice” leadership learnings and tools to help you and your people “stay in the game."

Stay in the Game: Leading Pharma and Biotech Teams in Tough Times is being presented by Lynda McDermott, President, of EquiPro International and airs on Thursday, December 17, 2009. For more details or to register, please visit our site at www.fxconferences.com

Cost & Effectiveness: Healthcare Reform and its Implications for Pharma & Devices

With health care reform on the horizon, the business case for quality and efficiency in health care has never been clearer. The new system will encourage payers to reimburse only for consistent and efficient care. Increasing transparency will make it easier for patients, who will in turn demand care that meets their needs. Preparing for the future of health care is therefore critical to the survival of many organizations. This changing health care landscape will have implications for medical providers and suppliers alike.

This session provides an overview of health care reform by understanding Massachusetts reform as a likely model. Dr. John Freedman outlines how such changes are likely to impact clinicians, as well as medical suppliers. This includes outlining key macro trends related to performance measurement, improvement, efficiency and cost containment.

Cost & Effectiveness: Healthcare Reform and its Implications for Pharma & Devices is being presented by Dr. John Freedman, Principal, of Freedman HealthCare, LLC and airs on Thursday, December 3, 2009. For more details or to register, please visit our site at www.fxconferences.com

Friday special - save 75% on "GCP for Medical Device Trials: Upcoming Revisions to ISO 14155"

An important standard for conducting medical device research is changing. How will it affect you?

Conducting global clinical trials in accordance with recognized standards provides improved assurance that clinical trial data will be accepted to support global marketing authorization applications. ISO 14155 (clinical investigation of medical devices for human subjects - Parts 1 and 2) is currently under revision.

This audio conference focuses on the status of revisions to ISO 14155, anticipated changes to the standard, and acceptance of the standard by regulatory authorities. This presentation reviews the required clinical investigation elements presented under ISO 14155 and provide tools for integrating the standard into your clinical research quality system.

Participants also receive a medical device clinical research map comparing requirements of ISO 14155 (2003) Parts 1 and 2, the draft revised ISO 14155, and FDA 21CFR 820. The speaker also provides attendees with an essential clinical investigation document checklist.

But hurry! If you purchase GCP for Medical Device Trials: Upcoming Revisions to ISO 14155 by November 12, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.

Protecting Data Under Current EU Pharma Legislation

European pharma legislation has seen several major changes come into effect over the past several years. Amongst others, the data protection rules have changed substantially. The data protection period for new approvals is now 8+2+1 years. The orphan protection, a full market exclusivity period, is 10+2 years. And the very recently introduced legislation on paediatric drugs (PUMA and PIP) plays an important role as well. The concept of the "Global Marketing Authorisation" needs consideration for the planning of the effective data protection period.

This presentation helps attendees understand current EU data protection rules and how best to operate within the regulatory framework.

Protecting Data Under Current EU Pharma Legislation was presented by Dr. Ulrich Granzer, with Granzer Regulatory Consulting & Services and aired on 2006-12-14. For more details or to download this event, please visit our site at www.fxconferences.com

Comparative Effectiveness Research: Threat or Opportunity?

Comparative effectiveness research (CER), a prominent component of legislative and regulatory efforts to rationalize the use of health care resources, improve outcomes and constrain the explosive growth of health care spending, is widely perceived as a financial threat by medical technology and pharmaceutical companies. During the current healthcare reform debate, industry has supported stringent limits on payers’ use of CER results in an effort to minimize its impact. But CER also has the potential to define new market opportunities for existing technologies and to open new pathways for the introduction of innovative diagnostics and therapeutics. Opposition to CER initiatives may foreclose significant growth potential for industry.

This presentation explores how CER is likely to be implemented, analyzes the nature of the threat posed by CER to the commercial status quo, and evaluates the opportunities that a robust implementation of a CER program would create.

Comparative Effectiveness Research: Threat or Opportunity? is being presented by Dr. Edward E. Berger, Principal and Founder, Larchmont Strategic Advisors and airs on Thursday, December 3, 2009. For more details or to register, please visit our site at www.fxconferences.com

Clinical Trial Success in Latin America

Latin America has proved to be a solidly performing region for clinical trials, catching the interest of global pharmaceutical and biotech companies. GCP (Good Clinical Practice) has been adopted as local regulatory requirement in most Latin American countries over the last decade. Since then, industry-funded clinical research has grown rapidly, and Latin America is routinely considered for global drug development programs. The reasons for this growth are simple: a large patient population, solid investigators with experience in clinical research, well-equipped qualified study institutions, strengthened clinical research infrastructure (laboratories, drug depot services and logistics), and internationally recognized standard treatments.

This audio conference reviews the major factors that have made Latin America a successful region for global clinical research studies. Drawing on recent experiences, the speaker outlines the benefits and challenges to managing Latin American clinical trials, while sharing practical advice on critical points to take into account when conducting trials in Latin America.

Clinical Trial Success in Latin America is being presented by Dr. Frederico Lerner, Senior Director of Operations, with PRA International and airs on Friday, November 13, 2009. For more details or to register, please visit our site at www.fxconferences.com

EDC Front to Back: Integrating Clinical Trial Data for Operational Benefit

Successfully implementing EDC depends on having processes in place that take advantage of the technology. Although it is generally possible to use EDC with processes that were designed for paper case report forms, there are many ways EDC can be integrated into the clinical trial process to make it more efficient, and depending on the goals for EDC, there are many metrics that can be captured to help establish benefits. Among these are cycle time for resolving queries, use of standards, quality of data, cost per form or datapoint, time between last patient visit and database lock.

This conference explores how processes related to EDC can be integrated into clinical trial processes for creating and deploying case report forms, as well as monitoring and managing trials. Our speaker shares insights on how to use lean concepts to look at the processes you have, identify opportunities for improvement and show measurable progress.

EDC Front to Back: Integrating Clinical Trial Data for Operational Benefit is being presented by Ross Rothmeier, Senior Director, EDC Portfolio, Clinical Development Services, with Covance and airs on Tuesday, November 17, 2009. For more details or to register, please visit our site at www.fxconferences.com