Communicating Policies & Procedures for the 21st Century Organization

Are your organization’s policies and procedures (P&P) out of date, unclear or inconsistent? Are you still reading and writing P&P in paragraphs with academic outlines accessible in dusty binders or in PDFs? This presentation introduces you to P&P communication as a body of knowledge, while exploring the latest trends and best practices for developing and managing P&P systems and information -- thus transforming performance for the 21st Century organization.

Led by a leading expert in P&P communication, this highly engaging presentation is filled with insights, anecdotes, resources and examples on and about policies and procedures.

Communicating Policies & Procedures for the 21st Century Organization is being presented by Raymond Urgo, Principal, with Urgo & Associates and airs on Wednesday, December 2, 2009. For more details or to register, please visit our site at www.fxconferences.com

Friday special - save 75% on "Hazard Analysis for Medical Devices Under IEC60601 and ISO14971"

If you have participated in hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an unmitigated hazard is high or low, or went off on a tangent evaluating very unlikely hazard scenarios, or wrestled with group members who consider hazard analysis meetings a waste of time.

This presentation looks at what is required under IEC60601 and ISO14971, and provides guidance on how to motivate groups to perform hazard analyses, structure meetings effectively and make them meaningful. It discusses documentation formats and hazard evaluation strategies, as well as presenting ideas on how to get the most benefit out of the risk management process.

But hurry! If you purchase Hazard Analysis for Medical Devices Under IEC60601 and ISO14971 by November 5, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.

Developing a Post-Approval Labeling Risk Management Strategy

Patient injured because of event described in black box warning: Company still liable, long established FDA approved warnings not sufficient...

Patient injured on generic drug: innovator company could be liable for inadequate warnings...

FDA-approved labeling is no longer a regulatory and liability safe zone. Companies face rapidly escalating FDA, product, reimbursement and patent liabilities tied to labeling management. Penalties, damages and fines are hitting billion-dollar-plus levels, with consideration of direct liability for executives being openly discussed. Traditional labeling development and management approaches that center on FDA approval and adverse event reporting are not up to the task of protecting companies and their executives. This audio conference explains what has happened over the last year and likely changes for the coming years and what to do now to position products for success and avoid liability or regulatory disaster.

Developing a Post-Approval Labeling Risk Management Strategy is being presented by Gary Gamerman, President, of Seraphim Life Sciences Consulting LLC and airs on Tuesday, December 1, 2009. For more details or to register, please visit our site at www.fxconferences.com

Maximizing Productivity Among Spanish-Speaking Employees

On occasion, even when material and instructions are translated well, employers do not get the response that they need from Spanish-speaking employees. This happens not because of a lack of desire to be a valuable employee, but because of Spanish speakers’ misconceptions about what it takes to be a valuable employee in the United States.

In this audio conference we will address common challenges for employers - apart from the language barrier - and will offer various strategies for improving morale and encouraging desired behavior like compliance with training and regulation and participation in benefit plans.

Maximizing Productivity Among Spanish-Speaking Employees was presented by Melissa Burkhardt, President, of Futuro Sólido and aired on 2008-02-13. For more details or to download this event, please visit www.fxconferences.com

To learn more about Spanish translations, please visit ForeignExchange Translations' web site.

The EU Perspective on Risk Management

Does your company market its products in Europe, or are you planning to enter the EU market? Have you taken the requisite steps to address risk management? Risk management must be an integral part of global product development and commercialization.

In this audio conference Dr. Blesse will provide a detailed overview of EMEA's Guideline on Risk Management Systems for Medicinal Products for Human Use and its legislative background. He will also provide examples of why this new regulation should not be perceived as another threat to industry, and how it offers strategic options.

The EU Perspective on Risk Management was presented by Dr. Stefan Blesse, with Granzer Regulatory Consulting and aired on 2007-07-19. To download this event, or for more details please visit our site at www.fxconferences.com

An Introduction to Analyzing Risk in Medical Devices

Medical device technology has become so advanced and diverse, it is extremely challenging to identify and anticipate all risks. Risk analysis is a regulatory requirement in which a medical device manufacturer is to identify a complete, unbiased picture of all possible hazards that could potentially be created by a device and design plans to avoid, mitigate, or control these hazards. The science of risk analysis and documentation of a risk management plan must incorporate the objective identification of defects or failures along with the subjective determinations of likelihood, severity, and acceptable risk limits during the entire life cycle of the medical device. This audio conference will provide an overview of risk analysis for medical devices, including information on the various international regulations with which manufacturers must comply.

An Introduction to Analyzing Risk in Medical Devices was presented by Amy Wise, Manager, Clinical Research, with PharmaNet and aired on 2008-07-31. For more details, or to download this conference please visit our site at www.fxconferences.com

Friday special - save 75% on "Pre-IDE Submissions and Meetings: Best Practices"

Companies that develop medical devices today have the option of informally meeting with the FDA staff in what is called a "pre-IDE meeting." This meeting will ultimately review their marking application in order to gain clarity about the agency’s expectations regarding the preclinical and clinical testing requirements for their device. In most cases, it is critical to take advantage of this opportunity.

This presentation describes how to optimize the pre-IDE submission of information to FDA, as well as the meeting that follows this submission, in order to maximize the information derived and facilitate your device development plan.

But hurry! If you purchase Pre-IDE Submissions and Meetings: Best Practices by October 29, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.

Best Practices for Back Translation as a QA Tool

Back translation is the translation of an already-translated text back into its original language. The use of back translation as a QA tool is becoming more prevalent in the life sciences industries, as often required by regulatory industries. These translated materials include product information, labels, informed consent forms, websites, software strings and a variety of other written content.

The issues presented by this growing trend in back translation are complex and often misunderstood by those removed from the localization process. Back translation as a QA tool can be successfully accomplished when these issues are fully understood and the process properly applied.

Best Practices for Back Translation as a QA Tool was presented by Hilary Davies, Senior Project Manager, with ForeignExchange Translations, and aired on 2008-08-06. For more details or to download this conference, please visit our site at www.fxconferences.com

Global Clinical Studies: Logistical Challenges from Supply to Assay

As the nature of clinical trials becomes more complex, the focus and expertise of personnel involved has become more specialized. To manage a successful study, awareness of all aspects in this process is critical.

In this audio conference, Ms. Oliver reveals all of the logistical challenges involved in clinical studies and effectively illustrates them through two scenarios: 1) drug distribution through delivery and 2) specimen transport from patient to assay.

The topics covered will include successful strategies for the transport of cold chain including regulatory and import considerations. Also discussed will be aspects of clinical sample logistics including site and lab selection, and customs.

Global Clinical Studies: Logistical Challenges from Supply to Assay was presented by Karen Oliver, Director Global Accounts, with World Courier and aired on 2008-10-08. For more details or to download this audio conference, please visit our site at www.fxconferences.com

Medical Device Clinical Evaluations: EU vs. US

In this presentation, Dr. Colquhoun explains the circumstances in which medical device manufacturers need to generate de novo clinical data. The audio conference also looks at the different types of clinical evaluations and the importance of conducting them in the EU (and USA).

The speaker presents an overview of the regulatory and quality controls of evaluations being conducted in the EU, and then highlights specific requirements in the four most popular European countries for medical device evaluations. These requirements are then compared and contrasted to those of the USA. Finally, the presentation also addresses general topics such as vigilance requirements, language and the operational process of conducting trials in the EU and USA.

Medical Device Clinical Evaluations: EU vs. US was presented by Helen Colquhoun, MD, CEO, with Pleiad Devices. For more details, or to download this event please visit our site at www.fxconferences.com

To learn more about German Translations, please visit ForeignExchange Translations website at www.fxtrans.com

Optimizing Preclinical Data for Medical Device Submissions to FDA

When preparing medical device submissions for FDA, it pays to get it right the first time. Not only are mistakes costly in terms of time and money, but they can leave a lasting and unfavorable impression on FDA. Fortunately, there are abundant resources available to help sponsors optimize their preclinical submissions.

In this audio conference, we look at the most common errors sponsors make when submitting preclinical data for medical devices to FDA, and how best to avoid them. Areas discussed include: using and justifying clinically relevant acceptance criteria, testing under appropriate conditions, optimizing study design, justifying protocol deviations, selecting appropriate test models, writing test reports with FDA in mind, providing adequately detailed descriptions, justifying sample sizes, including raw data, ensuring submission quality through proofreading, and clearly articulating intended use.

Optimizing Preclinical Data for Medical Device Submissions to FDA is being presented by Dr. Elisa Harvey, Senior Regulatory Consultant, with CardioMed Device Consultants and airs on Thursday, November 19, 2009. For more details or to register, please visit our site at www.fxconferences.com

Preparing to Translate: Tips for Faster, Easier, Cheaper Localization

We live in the era of globalization, when people are accustomed to dealing with colleagues and companies all over the world. and yet language barriers are still creating obstacles and challenges. In the life sciences and other industries where accuracy of information is paramount, getting your content to cross language boundaries flawlessly is still a difficult and often costly endeavor. Language will always have a human dimension, and communicating from one country or culture to the next requires planning, preparation and forethought. However, a little preparation can go a long way towards helping your company achieve substantial cost savings in the global market.

In this conference our speaker, veteran translation industry expert Sandra La Brasca, gives advice on how to prepare your materials for translation. She also illustrates how writing for translation ultimately results in cheaper, faster, more accurate global products.

Preparing to Translate: Tips for Faster, Easier, Cheaper Localization is being presented by Sandra La Brasca, Solutions Development Director, with ForeignExchange Translations, Inc. and airs on Tuesday, November 24, 2009. For more details or to register, please visit our site at www.fxconferences.com

Maximizing the Performance & ROI of Patient Recruitment Materials

It goes without saying that being able to communicate effectively with subjects is paramount in the world of patient recruitment. It is critical to have the necessary tools to ensure you are getting the most out of your global patient recruitment communication materials. This session reviews the established methodologies for accurately measuring the reading level of materials and addresses the impact of design and font elements on readability. Key cultural considerations are also discussed.

In this audio conference, our speaker examines the latest patient insights and presents principles for optimizing clinical trial communication pieces. Utilizing real-life examples, she also provides best practices for ensuring that recruitment materials retain their ability to convey compelling messages as they pass through the regulatory review process.

Maximizing the Performance & ROI of Patient Recruitment Materials is being presented by Mary Schwarz, Vice President, Core Services & Operations, with MMG and airs onWednesday, November 11, 2009. For more details or to register, please visit our site at www.fxconferences.com

Friday special - save 75% on "Risk-Based Software Validation for Medical Devices"

It isn't glamorous, and sometimes it isn't even considered a core competency necessary for our business. But in the medical device industry, software validation often consumes a huge portion of the budget for new software products, even when that wasn't the original intent. Unfortunately, software testing methods haven't kept pace with innovations on the product development side. Just as we look to new and improved ways to complete software development, medical device companies also need to be looking for new and improved ways to validate that software.

This audio conference examines the various approaches to software validation, and discusses how and why to consider risk as part of the validation process. The presentation also looks at ANSI/AAMI/IEC 62304:2006 Medical Device Software - Software Lifecycle Processes, and how it uses risk to drive software verification and validation.

But hurry! If you purchase Risk-Based Software Validation for Medical Devices by October 22, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.

Bridging the Linguistic Quality Gap: How to Measurably Improve Translation Quality

A cornerstone of the translation industry is the quality of the linguistic work completed, yet linguistic quality remains nebulous for many end clients and translation suppliers. Linguistic quality means different things to different organizations and for different types of projects. With lack of measurable quality systems comes the need to add steps to the process to “ensure” quality. This perceived increase in quality (more people looking at the text) results in slower time-to-market and increased costs.

This audio conference looks at how to move from an uncertain quality outcome to measurable, predictable quality, while presenting an approach to defining, measuring and improving linguistic quality within an organization. The speaker also discusses how to utilize these measurements to meet the organization’s business objectives on a broader scale, spanning improvements in cost and time-to-market.

Bridging the Linguistic Quality Gap: How to Measurably Improve Translation Quality is being presented by Sonia Monahan, Executive Vice President, Quality Systems, with ForeignExchange Translations, and airs on Tuesday, November 10, 2009. For more details or to register, please visit our website at www.fxconferences.com

FDA End-of-Phase 2 IND Meeting: Finalizing the IND Clinical Plan

The End-of-Phase 2 FDA meeting is the optimum time to obtain FDA input at a single Type B meeting on the remaining pharmacology and toxicology studies, chemistry manufacturing and controls (CMC) of the clinical formulation, and the overall IND clinical plan to support an NDA submission for market approval. Therefore, it is essential to give proper forethought and attention to the all-important steps in preparing for the EOP-2 FDA meeting.

In this conference our speaker, veteran industry expert Dr. Larry Hofmann, gives expert guidance on the optimum background and makeup of your EOP-2 FDA meeting team. He also discusses strategic planning for and preparation of the FDA meeting information package, which must include available pharmacology and toxicology, Phase 1 and Phase 2 study summaries, as well as a summary of CMC data on the previous IND clinical formulations and proposed Phase 3 formulation to support the proposed Phase 3 and remaining Phase 1 study protocols.

FDA End-of-Phase 2 IND Meeting: Finalizing the IND Clinical Plan is being presented by Dr. Larry Hofmann, President, of LMH Associates, Inc. and airs on Tuesday, November 3, 2009. For more information, or to register for this event please visit our site at www.fxconferences.com

Clinical Trial Supply Challenges in China, Russia, Brazil & the Ukraine

In the ever-expanding market of clinical trial supply, the challenges are becoming more and more complex. This is particularly true of the increasingly popular, but still developing, emerging market countries. This session focuses on four emerging market locations -- China, Brazil, Russia and the Ukraine -- that can pose many obstacles for logistics professionals. Our speakers share insights into country regulations, potential pitfalls during the importation process, and the potential effects on the cold chain that these mistakes may cause.

In this audio conference, our speakers also identify the most common denominators that can impede clinical supply chain distribution, while sharing their experiences and the actions taken to find solutions in this complex arena.

Clinical Trial Supply Challenges in China, Russia, Brazil & the Ukraine is being presented by Karen Oliver & Tracci Gilchrist, Director, Global Accounts & Manager, International Issue Resolution, with World Courier and airs on Thursday, November 12, 2009. For more details or to register, please visit our site at www.fxconferences.com

To learn more about Brazilian Portuguese translations, please visit ForeignExchange Translations website by clicking here

A Systematic Approach to Japanese Medical Device Submissions

Planning to take your products to Japan? Japan represents an 18-billion-dollar market for medical device manufacturers, and 40% of that is imports. However, entering the Japanese marketplace requires careful forethought and planning.

In this audio conference we provide an overview of the regulatory process in Japan including detailed timelines, cost estimates, and common mistakes made during market entry. The first part of the presentation will focus on the time and cost associated with a Japanese device submission, as well as outlining the steps needed to prepare for a submission. In the second part, our speaker discusses the initial steps of any Japanese submission and explains the difference in device classifications and approval categories. From there, we move on to common pitfalls and shortcomings of most foreign device submissions. This will include a detailed look at the different data and analysis needed, as well as a cultural section on dealing with Japanese reviewers, market authorization holders (MAH) and distributors.

A Systematic Approach to Japanese Medical Device Submissions is being presented by Michael Halper, President, of Small World Medical and airs on Tuesday, November 10, 2009. For more details or to register for this event, please visit our website at www.fxconferences.com

To learn more about Japanese Translations, please visit ForeignExchange Translations website at www.fxtrans.com

Achieving Compliance and Beyond with Simplified Technical English

Even the best product is only as good as its documentation and technical data, which allow the customer to use it safely and effectively. Simplified Technical English (STE) can help you meet documentation compliance requirements, and can also increase the efficiency and productivity of your employees. Formerly known as AECMA Simplified English, STE is an international standard (ASD-STE100) that helps to make technical documentation easy to understand and easier to translate for global customers. Simplified Technical English standardizes vocabulary, grammar and style, while letting users control their specific terminology.

In this session, Dr. Frans Wijma highlights some of the key benefits and rules of STE that can help to address 99% of the main challenges behind documentation processes, such as high cost, ease of translation, damage to product, delayed time-to-market and inadequate customer support.

Achieving Compliance and Beyond with Simplified Technical English is being presented by Dr. Frans Wijma, Managing Director, with Shufra and airs on Tuesday, November 3, 2009. For more details, or to register please visit our site at www.fxconferences.com

Studies in Special Patient Populations: More than Just a Regulatory Requirement

In global drug development, supportive trials -- such as those in special patient populations -- are required to complement the regulatory submission package. Studies in hepatically or renally impaired patient populations are therefore often performed in parallel to Phase III trials in order to have them completed when the NDA is filed. However, in aging populations with reduced organ function, these studies can provide valuable information on interpretation of clinical data generated in Phases II and III.

In this audio conference, the speaker discusses the strategic and organizational aspects of these trials, while providing a deeper understanding of their value in special patient populations.

Studies in Special Patient Populations: More than Just a Regulatory Requirement is being presented by Dr. Christian Reh, Vice President, Clinical Affairs, Early Development Services, with PRA International and airs on Thursday, October 29, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Navigating State Sales & Marketing Laws for Drugs & Medical Devices

Marketing your pharmaceutical product or medical device while adhering to ever-changing state and federal laws can pose a signifcant challenge. For example, on March 11, 2009 the Massachusetts Department of Public Health issued requirements similar to those of other states, imposing restrictions on pharmaceutical and medical device manufacturers’ sales and marketing activities. This session looks at current state laws regulating the sales and marketing practices of pharmaceutical, biotech and medical device companies, with a particular emphasis on the new requirements in Massachusetts and Vermont.

In this conference, our speaker examines the federal legislation that regulates pharmaceutical and medical device sales and marketing, while also providing insight into how companies can develop compliance plans to take into account the "patchwork" of state laws, applicable federal laws and industry guidance.

Navigating State Sales & Marketing Laws for Drugs & Medical Devices is being presented by Maria D. Buckley, with Nutter McClennen & Fish LLP and airs on Wednesday, November 4, 2009. For more details or to register to attend this event, please visit our site at www.fxconferences.com

Achieving Benefits Plan Buy-In from Spanish-Speaking Employees

Even when employee benefits material is well translated and presented in Spanish, many companies find that Spanish speakers are still reluctant to participate and instead opt out of very valuable opportunities for health coverage, retirement plans, etc. This tendency is frustrating to HR professionals, brokers and benefits providers who have invested putting together a Spanish presentation.

This discussion addresses misconceptions Spanish speakers commonly hold about insurance and finance in this country and present practical and cost-effective strategies for conducting effective enrollment meetings and maximizing participation among Spanish speakers in benefit plans.

Achieving Benefits Plan Buy-In from Spanish-Speaking Employees was presented by Melissa Burkhardt, President, of Futuro Sólido and aired on 2008-05-28. For more details on this conference, or to download it please visit our site at www.fxconferences.com

Adaptive Trial Design: Streamlining the Clinical Supply Process

Adaptive trial design has generated intense press coverage and industry excitement as it represents a significant change from traditional study design. This type of trial uses real-time patient information to make critical trial decisions as the study is ongoing. While this design offers the pharmaceutical industry the opportunity to speed up the drug approval process, mid-trial changes to treatment arms and patient populations has a significant impact on drug supply management.

From a clinical supply perspective, the inventory implications of an adaptive trial design must be carefully analyzed. Cost vs. benefit analysis is paramount as well as identifying inventory strategies for all possible scenarios well before first patient in (FPI).

Adaptive Trial Design: Streamlining the Clinical Supply Process was presented by Geert Langendries, with Covance IVRS Project Management Group and aired on 2007-12-05. For more details or to download this audio conference, please visit our site at www.fxconferences.com

Designing Web Sites for International Users

When it comes to building and maintaining international Web sites, many companies suffer from an English-centric world view. Neglecting global markets with your site, means you risk alienating potential customers and forgoing revenue opportunities. Whether your company is international "from the ground up" or selling products into select markets, it can benefit from a well-implemented global Web strategy.

This audio conference helps you successfully manage the daunting task of designing and maintaining a high-quality international Web presence.

Designing Web Sites for International Users was previously recorded and presented by Andres Heuberger, President, of ForeignExchange Translations. For more details, or to download this conference please visit our site at www.fxconferences.com