Software as a Device: What You Need to Know About the New MDD

The current landscape of device regulations, as directed by the MDD, has undergone some substantial changes. The directive, published in April 2007, becomes a requirement in March of 2010. MDD: 93/42/EEC defines new regulatory challenges for device manufacturers groups and notified bodies, specifically in post market surveillance and vigilance.

It is time to start planning for the new requirements of the new MDD. Classification rules have been modified with some former devices now falling into higher class ratings, essential requirements have been changed, stricter definitions relating to medical devise, and more controls on software are jut some of the major changes.

Software as a Device: What You Need to Know About the New MDD is presented by Eric Henning, Sr. Project Manager, of KEMA. For more details on this audio conference, please visit our site 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.

This event is presented by Melissa Burkhardt of Futuro Sólido. To learn more, please visit www.fxconferences.com.

Writing & Designing for an International Audience

Are you responsible for generating content for global markets? Are you worried that the meaning in your message might be lost or altered because of cultural differences? Culture, translation, writing, and design interweave in curious ways when preparing content for an international audience. These elements require important skills for creating global content, especially given the increasing pressure to standardize and comply with various international and internal standards.

This presentation will highlight some key contradictions inherent in writing and designing for a multicultural and multilingual audience and discuss proven strategies for their resolution.

This event is presented by Nancy Hoft of Nancy Hoft Consulting. To learn more, please visit www.fxconferences.com.

Meeting the Challenges of Global Oncology Trials

Successful global oncology trials require careful planning, starting with looking at the strategic elements that span people, process and technology. Challenges in clinical research in oncology today include multiple new agents for multiple new targets combined with an increase in the number of patients needed to demonstrate that a therapy provides a significant benefit for patients. There is also a need to minimize the time it takes to go from basic science discoveries into clinical studies. The risk posed by delays in study start-up and patient recruitment can be mitigated by proactively planning for the study.

Planning needs to reflect the traditional and nontraditional considerations of feasibility and study design and incorporate trends and best practices. Patient recruitment is a key strategic consideration, along with epidemiological and genetic factors. Facilities, expertise and other resources along with technology play a key role in global trial planning.

Area-specific regulatory requirements vary in terms of standards of care, and differences among healthcare systems influence trial planning, as do local and cultural considerations.

This presentation will focus on the central challenges in global oncology trials today and make recommendations about how they might be addressed to mitigate risks in terms of timelines and costs.

This event is presented by Ute Berger of PRA International. To learn more, please visit www.fxconferences.com.

Medical Device and IVD Registration in China

China represents an attractive market for many mutinational companies due to two key elements: the dense population and huge consumer base; and the country's rapid economic growth. Due to the government policy of economic regeneration and the urbanization reshaping most regions, Chinese people are gradually becoming more affluent. As a result, there has been exponential growth in the medical device and IVD market in recent years. This phenomenon is similar to the drug industry in the early 90's.

The market potential for these two sectors is simply tremendous. Although there are different predictions and calculations from various experts regarding the market size of the medical device industry, a conservative estimate is over five billion US dollars. China is already the number two player in the Asia market and is just behind Japan in terms of volume. But while the potential is attractive, the registration process for medical devices and IVDs in China is quite lengthy, and the regulatory hurdles significant.

This presentation will provide an introduction to the regulatory environment in China, and the requirements and process for registering medical device and IVD products.

Medical Device and IVD Registration in China is presented by Janice Ma, Operations Director & Co-founder, of ChinaGate Ltd. For more details on this conference, please visit our site www.fxconferences.com

Predicting and Preventing Protocol Violations

Often, a large percentage of sponsor clinical trial budgets are allocated to remediation, focused towards fixing problems after they occur, rather than towards proactive activities which could help predict and prevent errors.

This presentation will discuss clinical trial protocol violations as a consequence of stressed "environmental" conditions at investigative sites, the potential risk for patient safety and the overall impact on the success of clinical trials. The speaker will examine why protocol violations are so pervasive, as well as conventional measures to handle them and their inability to adequately detect and address them. The presentation will look at Failure Mode and Effect Analysis (FMEA) as a proactive approach to predict and prevent protocol deviations/violations. The presentation will also discuss how clinical trial protocol violations are preventable within a risk management paradigm, and will outline a process for addressing protocol violations using the FMEA approach.

Finally, the presentation will address the implications to the sponsor's clinical trial budget of the proactive, predictive, prevention approach embodied by FMEA and how additional investment up-front can lead to improved clinical trial performance.

This event is presented by Brett Bishop of Covance. To learn more, please visit www.fxconferences.com.

Risk Management Strategies: US vs. EU

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 commericalization.

In this audio conference, our speakers will compare and contrast the FDA and European Medicines Agency approaches to risk management. Dr. Stemhagen will focus on the US approache, while Dr. Blesse will provide an overview of EMEA's Guideline on Risk Management Systems for Medicinal Products for Human Use. We will also explore the epidemiological methods for post-authorization safety studies, and ways to reduce risk.

This event is co-presented by Annette Stemhagen of United BioSource Corporation and Stefan Blesse of Granzer Regulatory Consulting. To learn more, please visit www.fxconferences.com.

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.

This event is presented by Hilary Davies of ForeignExchange Translations. To learn more, please visit www.fxconferences.com.

The ABCs of FDA: Regulatory, Fraud and Abuse Issues

More and more companies are venturing into medical devices, drugs or biologics in an effort to diversify or to promote new biotechnologies. At the same time, the United States government is taking a more active role in regulating the manufacturers, providers and payers in the healthcare industry. The collision of these two trends – increased interest in marketing healthcare products along with increased government involvement in regulation and enforcement – require companies to attain FDA regulatory compliance and prevent fraud and abuse violations in order to be successful in this industry and avoid multi-million dollar fines and penalties.

In this audio conference, the speaker will address the basic things that people and companies need to know about dealing with the FDA and succeeding in the life sciences industry.

This event is presented by Bethany Gilbert of Hodgson Russ. To learn more, please visit www.fxconferences.com.

IEC 60601-1 3rd Edition: Setting the Standard for Electromedical Devices

The third edition of IEC 60601-1 is now a year old; however, this standard is so different from the second edition that manufacturers and certifiers alike have yet to get their act together. One of the major reasons for this is the explicit introduction of risk management as a part of IEC 60601-1.

Risk management is inextricably woven into the fabric of this standard. Not only is there a general requirement for manufacturers to establish a risk management process that conforms to ISO 14971 (clause 4.2), but there are also more than one hundred times where the standard directs manufacturers to determine risk acceptability in applying a particular clause.

This audio conference will examine how risk management is used in the third edition, as well as the implication both for manufacturers and for third party certifiers.

This event is presented by Harvey Rudolph of Underwriters Laboratories. To learn more, please visit www.fxconferences.com.

Handle With Care: Clinical Data Cleaning

Clinical trials are becoming more challenging, time-consuming and resource intensive. In addition to the pressure for timeliness which face the sites at the front lines of clinical trials, today's standard data cleaning methods cater to approaches that are at high risk of inadvertently introducing bias into the data, thus skewing the trial results.


This presentation explores the premise that the very process of data cleaning has the potential to in fact do more harm than good in more detail. The presentation also introduces predictive, proactive, and preventative real-life measures that can be deployed to manage the level of errors and the need for data cleaning, thus improving the overall data quality.

Handle With Care: Clinical Data Cleaning is presented by Elaine Job, Executive Director, Data Management Late Stage Development Services, of Covance, Inc. For more information on this audio conference, please visit our site www.fxconferences.com

How to Respond to FDA 483s and Warning Letters

Dealing with the FDA is never easy, but two of the most disconcerting times for medical device companies are when an FDA investigator issues a List of Observations (the FDA483) at the conclusion of an inspection, and when you receive a letter from the FDA by certified mail that has "Warning Letter" written at the top.

Now what do you do? The 483 never says you must reply either verbally or in writing, but the warning letter states that you must respond to FDA concerns in writing within 15 days. How do you respond to the 483 and/or the warning letter? Does it make a difference in how you make your response? Who reads your response and what effect does a good response have on the FDA's next regulatory step? Join us as device consultant and former FDA supervisor Alan Schwartz provides the answers.

How to Respond to FDA 483s and Warning Letters is presented by Alan Schwartz, Executive Vice President, of mdi Consultants, Inc. For more information on this audio conference, please visit our site www.fxconferences.com

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

One of the key items that need to be resolved before a project can go through a complete translation for a medical device is to know the marking and labeling requirements of the devices, the user manuals, the screen prompts, and the packaging. One key aspect of marking and labeling requirements comes from IEC 60601-1, the standard for medical electrical devices. IEC 60601-1 has gone through a major paradigm change in the way medical electrical devices are evaluated.

Along with the change in paradigm are some new and modified requirements and test methods for the marking and labeling of these devices. This audio conference will highlight changes to marking and labeling requirements from the second to the third edition.

How to Mark & Label Devices Under IEC60601-1 3rd Edition is presented by Leo Eisner, Product Safety & Regulatory Consultant, of Eisner Safety Consultants. For more details on this audio conference, please visit our site www.fxconferences.com

EN 15038:2006 - A Tool for Assessing Translation Providers

Do you wish there were objective criteria for assessing your current or prospective translation providers? With so many agencies vying for your business, wouldn't it be nice if you had a checklist you could use for your RFP process or annual vendor reviews? Well, there is help: European standard EN 15038:2006, "Translation Services - Service Requirements." Forget the dry title. This is exciting news to those in the life sciences industry, where metrics and standards are vital. The European Committee for Standardization has done the hard work of creating a way for companies to objectively rate their translation providers.

EN 15038 provides guidance on such topics as human resources, linguist competency, technical resources, project management, client relationships and quality management. In short, it covers all the important areas that will determine the level of service and quality you can expect from your translation provider.

EN 15038:2006 - A Tool for Assessing Translation Providers is presented by Jason Heaton, Marketing Manager, with ForeignExchange Translations, Inc. For more details on this presentation please visit our site www.fxconferences.com

FAS 141(R) and IFRS 3: Important Changes in Accounting for Business Combinations

Companies involved in either side of an acquisition need to pay close attention to the rules governing the accounting for such a transaction. Several months ago, the US-based Financial Accounting Standards Board (FASB) and UK-based International Accounting Standards Board (IASB) each issued new proclamations making meaningful changes to those rules.

This audio conference will review highlights of those changes. It will give any management team considering a purchase or a sale an updated awareness of particular aspects of a potential transaction that might need to be re-thought because of those changes. The changes take effect for transactions that close after July 1, 2008 (IASB) or December 31, 2008 (FASB). Thus, managers need to consider the changes now for any transaction that is not already well underway and scheduled to close before those dates.

This audio conference is presented by Michael A. Martorelli, CFA, Director, of Fairmount Partners. To learn more details, please visit our site www.fxconferences.com

Asian Clinical Trials: What to Know Before You Go

Thinking of conducting clinical trials in Asia?

Certainly more and more pharmaceutical companies are, and with good reason. The predominantly secondary healthcare environment, treatment-naïve patients and large population can mean less time to recruit and faster clinical development. Data quality is high, there are fewer competing studies, and the presence of large hospitals means more patients per site and dramatically reduced trial costs. But jumping on the Asian bandwagon without the proper forethought and knowledge could turn your trial into a tribulation

This audio conference is presented by Anthony Bishop, Quintiles East Asia. For more details, please visit our site www.fxconferences.com

Good Reprint Practices: What the FDA Says Now

After years of arguing about the legality of distributing medical journal articles concerning unapproved uses for approved drugs and devices, the FDA has finally released a draft guidance recognizing such distribution as a normal activity. The guidance on Good Reprint Practices outlines the type of articles suitable for dissemination to healthcare professionals, the types of articles which should not be disseminated, and acceptable methods of distribution. However, in some ways this new guidance may be even more rigorous than past programs. It could even be argued that some of the provisions are unconstitutional.

In this audio conference, our speaker will discuss the scope of the draft guidance on Good Reprint Practices and provide expert advice on implementing a program to ensure compliance for drug and device companies.

Good Reprint Practices: What the FDA Says Now is presented by Robert J. Klepinski, FDA Compliance Attorney, of Fredrikson & Byron. For more details, please visit our site www.fxconferences.com

Optimizing Country Selection for Clinical Research

A number of elements can influence decision-making when developing a global footprint within the clinical research environment. These elements include: knowledge of the regulatory framework and timelines, suitability of the healthcare setting, compatibility of standard of care, interest within the physician community, internal resource availability to train sites and monitor high quality data, and the competitive landscape.

In this presentation, Dr. Stansfield will discuss these elements, with a primary focus on the ways that patient access can influence the successful outcome of clinical research for a new product. She will also highlight the pros and cons of different approaches.

The audio conference is presented by Susan Stansfield, PhD, Executive Vice President Product Registration Europe, Africa & Asia Pacific, of PRA International. For more details, please visit our site www.fxconferences.com

Managing the Shift to Electronic Submissions

The electronic common technical document (eCTD) presents many challenges to a Sponsor organization, but may also yield significant benefits through increased efficiencies and improved reviews by regulatory agencies. Sponsor organizations that have decided to adopt the eCTD now have the challenging task of managing and implementing the paradigm shift from paper to electronic regulatory submissions.


The first of many challenges is to evaluate and modify existing document preparation processes to accommodate differences between paper and eCTD. Once these changes have been identified, the next step is to convince upper management the changes are necessary to move the organization forward to preparing electronic submissions. Another challenge is working with vendors to receive electronically-compliant documents. The eCTD will require sponsor organizations to rethink their business and those with whom they do business.

This audio conference is presented by Gina Ross, Director, Managing Consultant, Regulatory Publishing Services, of Beckloff Associates a Cardinal Health Company. To learn more details please visit our site www.fxconferences.com

Data Management for Medical Device Trials: Best Practices

There are no regulations in the USA or EU that specifically govern case report form development or data management practices. There are some guidelines produced by professional bodies of data managers. This presentation will cover the range of data management tasks from CRF design to data entry to raising and resolving queries to tracking all aspects of data management.

There will be a short discussion of importation of data as well as safety management as it pertains to data management. Throughout the presentation, general guidance on best practice will be given.

This audio conference is presented Helen Colquhoun, MD, CEO of Pleiad Devices. For more information of Data Management for Medical Device Trials: Best Practices, please visit our site www.fxconferences.com

An Overview of EMEA & Centralized Procedure

European legislation governing pharmaceutical regulations has undergone a major revision in recent years. It began with an initiative of the EU Commission in 1999, and culminated in the implementation of a new regulation concerning the structure and the name of the EMEA, the European Medicines Agency.

These sweeping changes also affected the centralised procedure, with major revisions regarding fast track, conditional approval and approval under exceptional circumstances. Furthermore, the basic EU pharma legislation, Directive 2001/83, has been changed to adapt to the needs of the enlarged European Union including 25 full members plus Iceland, Norway, and Liechtenstein.

In this audio conference, Dr. Granzer will discuss the changes impacting pharmaceuticals in the EU, and how best to navigate the maze in getting your products to market.

This audio conference is presented by Dr. Ulrich Granzer, of Granzer Regulatory Consulting. For more details, please visit our site www.fxconferences.com

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.

Analyzing Risk in Medical Devices will be presented by Amy Wise, Manager, Clinical Research of PharmaNet. For more information please visit our site www.fxconferences.com.

An Introduction to Regulatory Writing: Creating an Effective Message

Did you ever wonder what reviewers look for in your regulatory submissions? This audio conference combines the results of two in-depth interviews regarding effective writing in regulatory submissions and with known effective writing techniques and practices. The interviews were with a previous FDA reviewer and a current reviewer for a large Notified Body. Both interviewees shared their reactions to the quality and effectiveness of the writing in the hundreds of submissions they have each reviewed.

Topics include: analyzing the audience, identifying topics, organizing the topics in a logical way, applying document design principles, establishing document management conventions, writing, and assessing the effectiveness of your writing.

This conference is presented by Nancy Hoft of Nancy Hoft Consulting. For more details please visit our site www.fxconferences.com

Leveraging Clinical Development Opportunities in India

India presents a compelling environment for global clinical trials because of its access to investigators, large patient populations with diseases of the industrialized and developing world, a cost-effective, English-speaking graduate workforce, and progressive regulatory environment. These benefits are now well recognized by the global pharmaceutical industry. Moreover, because of India's pristine FDA audits, continued streamlining of regulatory approvals and demonstrated intent to uphold international intellectual property standards, the country has become even more attractive as an important locale for clinical development.

As a result, multinational pharmaceutical companies are striving to build clinical development capabilities within their local operating companies in India, and the country's nascent CRO industry is enjoying an annual growth of about 40%. This, however, poses resourcing constraints and unresolved ethical issues about the robustness of patient consent. Hence, it is becoming increasingly important for sponsors to select investigators, sites and resources that will be able to deliver data of the quality and integrity that they seek. This presentation will draw on recent experiences and case studies related to the benefits and challenges of conducting clinical trials as well as data management in India.

This audio conference is presented by Nermeen Varawalla of PRA International. To learn more, please visit www.fxconferences.com.

CE Marking: Pitfalls and Best Practices for IVD Directive Language Requirements

Back in 2002, the $9 billion U.S. in vitro diagnostics (IVD) industry was ill prepared to meet the strict new regulations contained in the European Union's IVD Directive. IVD manufacturers were realizing that translation is critical to earning the CE mark.

Manufacturers that lacked effective plans for complying with the language requirements of the directive risked losing revenue and market share. Translation quality control, global labeling strategies and in-country reviews presented new challenges for the majority of in vitro diagnostics manufacturers who were dealing with non-English texts for the first time.

This audio conference is presented by Andres Heuberger of ForeignExchange Translations. To learn more, visit www.fxconferences.com.

How to Profit From Your Translation Memory

Translation memory (TM) technology is a widely accepted facet of the translation industry today. In its early stages, translation buyers were often co-beneficiaries of the TM savings. Today, they have taken a far more proactive approach by controlling the TM data and its use. With growing amounts of data and a new sophistication in the employment of technology, translation processes are increasingly streamlined, with a resulting rise in both quality and cost-efficiency.

The next logical step, use of industry-wide data pools or the trading of TM data, has typically been dismissed as undoable. TM data is often viewed as a proprietary asset that can be neither shared nor traded. This conference will outline how TM data can be shared safely and successfully, why these concepts will take hold in the mid-term future, and the effect this may have on the language industry.

This audio conference is presented by Jost Zetzsche of TM Marketplace. The learn more, visit www.fxconferences.com.

SPL & Beyond: XML in the Life Sciences

As Structured Product Labeling (SPL) continues to evolve and become adopted throughout the FDA, organizations must ensure their original approach to SPL compliance is the best strategic fit for the enterprise. Initially, the goal for most organizations was focused solely on implementing systems and/or processes to achieve SPL compliance. Depending on your approach, SPL compliance can either result in additional time and cost to the overall submission process, or provide long-term value across the enterprise.

With additional XML-based standards under development, and the ability for structured content to drive efficiencies throughout an enterprise, it is prudent to review your overall approach to structured content authoring and publishing. This presentation will look at how XML can be used to manage content for SPL submissions to the FDA, Product Information Management (PIM) submissions to EMEA, as well as other uses such as standard response letters for customer contact centers.

This audio conference is co-presented by Don Bridges of Data Conversion Laboratory and Joe Jenkins of RWD Technologies. To learn more, visit www.fxconferences.com.

IVD Directive Compliance: Understanding Labeling and Language Requirements

With the introduction of the In Vitro Diagnostic Directive (IVDD) in Europe in 2003, multilingual labels and instructions are required for the diagnostics industry to comply with E.U. regulations.

Companies are faced with the dilemma of providing the appropriate and required information in a multilingual format while making the information readable on a variety of label sizes. The use of internationally recognized symbols as a substitute for text has been actively promoted to provide users with a uniform method of obtaining product information. Yet many diagnostics companies are struggling with the issues that surround multilingual label design and international symbology.

This audio conference is co-presented by John Webster of Medical Device Consultants and Andres Heuberger of ForeignExchange Translations. To learn more, visit www.fxconferences.com.

Understanding the Principles and Pitfalls of 510k Submissions

Obtaining premarket clearance for medical devices can be a challenging task. However, it is somewhat less daunting when you start out with a solid understanding of what is expected by the FDA and how the review process works.

This audio conference provides an understanding of the technical requirements of 510k submissions, provide practical advice on preparation of the documents and give an overview of the options and strategies associated with obtaining premarket clearance for medical devices. The speaker also draws on her extensive experience to provide valuable insights for minimizing the pitfalls and common mistakes associated with these types of FDA submissions.

This audio conference is presented by Rebecca Pine of Eisner Safety Consultants. To learn more, visit www.fxconferences.com.

Best Practices for Implementing ISO14971:2007

Implementing risk management into the medical device development process has become a regulatory necessity. However manufacturers still struggle to not only fulfill the requirements of ISO 14971, but also to find ways to implement risk management into the overall operating framework in a meaningful way.

This audio conference discusses the elements of risk management, the regulatory requirements and current interpretations, as well as implementation of a compliant risk management process. Additionally, the presentation will provide practical tips to optimize the benefits of implementing risk management into the development process while at the same time minimizing the administrative burden imposed by the additional process.

This audio conference is presented by Markus Weber of System Safety Inc. To learn more, visit www.fxconferences.com.

Overcoming Cultural Barriers to Global Marketing

Jean Monnet, the founder of the European Community, once declared, "If I were again facing the challenge to integrate Europe, I would probably start with culture." Culture is the context in which things happen. Whether you develop, market, sell or purchase products for a global audience or interact with people from around the world -- even if they work in the next cubicle -- you must address the issues of culture to be effective.

How and why do the needs of people from one country differ from those in a different country? How do you assess this? In this presentation we will examine definitions of culture and consider how cultural differences are expressed. We will then explore the use of tools called cultural models, review the variables that define these models of culture, and weigh their usefulness. We will also discuss how to develop a customized model of culture for your particular context.

This audio conference is presented by Nancy Hoft of Nancy Hoft Consulting. To learn more, visit www.fxconferences.com.

Best Practices for Building Global eLearning Programs

To reach a global audience, e-Learning programs need to be localized. This can be an expensive undertaking, but the cost can be minimized through the application of good program design. In this audio conference, we will explore how to maximize the value of your e-Learning content by following best practice in designing and building your programs. Choosing a localization partner is key to maximizing quality and minimizing costs.

This audio conference will address the following:

• Best practice in e-learning


• Internationalizing your e-learning program


• Cultural issues that can affect the localization process


• Applying design rules to minimize localization costs


• How to choose the right localization partner

This audio conference is presented by Eoghan O'Maolain of Rendition Digital. To learn more, visit www.fxconferences.com.