3 Steps to Successful Translation Management

Translators have been around since the time of the Babylonians, yet the US translation industry is still relatively new. Yellow Pages translation bureaus are a dime a dozen, but pharmaceutical, device and diagnostics companies need a true partner that can help them effectively manage the translation process.

This audio conference will give you the skills to evaluate different vendors, service delivery methods and quality. It will also enable you to put in place a process to document, measure, audit and improve your overall translation activities.

3 Steps to Successful Translation Management is presented by Andres Heuberger, President, ForeignExchange Translations, Inc. This audio conference was previously recorded on 2008-01-30 and is now available for download at www.fxconferences.com

Adapting Patient Recruitment to Global Cultures

Patient recruitment is often mistakenly equated with advertising, when in actuality it is a considered collection of practices in response to a problem or a set of risks. The discipline is still new to many world regions outside of North America, presenting challenges both in acceptance and in practice among study professionals globally.

This audio conference will focus on overcoming those challenges in order to successfully conduct patient recruitment globally using the most appropriate, effective, and ethically acceptable tactics. In addition, it will also illustrate methods for culturally adapting patient recruitment practices - particularly creating patient communications (including advertising) - to resonate with target populations in each country.

Adapting Patient Recruitment to Global Cultures is presented by Rob Laurens, Leader, Creative Services & Matt Stumm, Senior Art Director, of BBK Healthcare. This audio conference was previously recorded on 2008-01-23 and is now available for download at www.fxconferences.com.

Protecting Data Under Current EU Pharma Legslation

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.

This event is presented by Ulrich Granzer, owner of Granzer Regulatory Consulting & Services. To learn more, please visit 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 addresses general topics such as vigilance requirements, language and the operational process of conducting trials in the EU and USA.

This event is presented by Dr. Helen Colquohoun of Pleiad Devices. To learn more, please visit www.fxconferences.com.

The FDA & Risk Management for Biopharm Sponsors

What is required of biopharmaceutical sponsors by the FDA when it comes to managing risk? What are the best strategies for implementation?

The first part of this presentation focuses on the status of the FDA Guidance Documents on Risk Management back in 2005, including a description of what the FDA has termed the "toolbox" for Risk Minimization Action Plans (RiskMAP). The second part discusses the conduct of these unique programs through large simple trials, registries, and other approaches.

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

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 new IVD Directive. With only four business quarters left before the December 2003 deadline, IVD companies were realizing that translation is critical to earning the CE mark.

Manufacturers without 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 diagnostics manufacturers who were dealing with non-English texts for the first time.

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

The Foreign Corrupt Practices Act: Compliance Strategies

The Foreign Corrupt Practices Act (FCPA) is a U.S. anti-corruption law jointly enforced by the Department of Justice and the Securities and Exchange Commission. Its main provisions deal with improper payments to foreign offficials and questionable accounting practices to cover up these sorts of transactions. Violating FCPA requirements can result in criminal and civil penalties, and the law has had a major impact on the way companies conduct business abroad. The requirements of the FCPA are complex and apply to both companies in the U.S. and foreign-based companies subject to U.S. securities laws. Past enforcement actions have crossed industry boundaries and included the oil industry, telecommunications and pharmaceuticals. Recently, an increase in FCPA enforcement activity in the medical device industry has caught the attention of CEOs, CFOs, and Marketing and Sales executives.

In this audio conference, our speakers will combine their experience with real-world case studies to provide a clear background on the FCPA requirements and enforcement trends, along with practical compliance strategies to avoid prosecution.

The Foreign Corrupt Practices Act: Compliance Strategies is presented by Bethany Gilbert & Michelle Merola, of Hodgson Russ LLP. For more details please visit our site www.fxconferences.com

Implementing GMP for Combination Products: What Applies When?

For 10 years now FDA has been progressively developing its regulation of the complex product area known as combination products, with very few formal guidance documents for industry. Combination product manufacturers are faced with the challenge of deciding how to implement a quality system that is compliant with applicable Good Manufacturing Practices and Quality System Requirements.

In this audio conference, our speaker will discuss the applicable guidance and current thinking on meeting FDA expectations for combination products, sharing specific examples of accepted practices and how FDA regulations and guidance are currently being applied. The presentation will also examine the recent history of combination product approvals in the US, as well as important trends and issues for the future.

Implementing GMP for Combination Products: What Applies When? is presented by Linda Alexander, CEO & Co-Founder, Alquest, Inc. For more details, please visit our site www.fxconferences.com

A Practical Guide to Stress Management

"There cannot be a stressful crisis next week. My schedule is already full." - Henry Kissinger

Stress. It is a part of life. It cannot be avoided. For many, stress is perfectly manageable and taken in stride. Indeed, some even thrive on stressful situations, while for others it can become debilitating, impacting relationships, job performance and health. Book stores have entire sections devoted to stress and stress management, and the phone book is crowded with professionals who make a very good living trying to help people deal with stress. The fact is, most of us know what stresses us out, and we have a pretty good idea of how to reduce that stress. But knowing it and taking action are two very different things. This audio conference will present a layman's view of stress and stress management, identifying sources of stress and discussing the ways in which we can reduce the impact stress has on our everyday lives.

A Practical Guide to Stress Management is presented by Lindsay Gregory of ForeignExchange Translations. For more details on this audio conference, please visit our site www.fxconferences.com

Bulletproofing Personnel Policies Against Litigation

Are you concerned that your HR policies and processes might be leaving you vulnerable to lawsuits? No one sets out to create policy risks and personnel litigation. Yet every year a new crop of employee lawsuits are spawned by claims of inattention, inconsistency or unfairness in applying organization policies.

Learn how to avoid the costly loopholes in personnel policy and you could potentially save your company. This informative seminar helps you learn the basis of good policy and the importance of enforcing it consistently. There are basic rules you must know about workplace grievances and disciplinary issues to limit or avoid negative action altogether, especially litigation.

Grandma was right, you know. An ounce of prevention is worth a pound of cure.

Bulletproofing Personnel Policies Against Litigation is presented by Jay Rush, Director of Contracts & Legal Compliance, of Policy Technologies International. For more details please visit our web site www.fxconferences.com

Alternative Sites for Clinical Trials: Latin America

This is the third in a series of audio conferences featuring speakers from Covance discussing the benefits and pitfalls of using non-traditional sites for clinical research.

Conducting business in Latin America has proven beneficial to pharmaceutical companies by providing expanded patient access, including medically naive patients. This region also provides access to unique clinical indications. Business in the region continues to grow in spite of the many challenges that still exist and the regulations that continue to impact access to specimens in the different countries. In this audio conference, Conchita Delgado addresses these challenges and present solutions to overcome them.

Alternative Sites for Clinical Trials: Latin America is presented by Conchita Delgado, Manager, Latin America, of Covance Central Laboratories. For more details on this audio conference, please visit our web site www.fxconferences.com

Alternative Site Selection: China

This will be the second of two Covance audio conferences dealing with alternative site selection, and will focus on opportunities for the conduct of clinical research in China. This presentation will provide an overview of the current clinical research environment in China and explore reasons why China should be considered as part of global drug development strategies.

Alternative Site Selection: China is presented by Dr. Brett Bishop, Executive Director Operational Strategy & Planning, of Covance. For more details please visit our site www.fxconferences.com

Monitoring Essentials for International Medical Device Trials

The FDA publishes warning letters on its website, and these are increasingly concerned with the monitoring of medical device clinical studies. It is clear that some device manufacturers are finding it difficult to comply with the FDA's current guidance and regulations governing the monitoring of medical device clinical trials. In Europe, monitoring standards are similar but there is often a lack of clarity of what is expected because the audience for the clinical trial application (the competent authorities) and the CE marking dossier (the notified bodies) is different.

In this presentation, Dr. Helen Colquhoun will summarize the regulations and official guidance governing the monitoring of medical device clinical trials in the USA and EU. She will also provide the audience with the essentials necessary to ensure compliance with these regulations, including giving practical examples of what monitors need to do at site. Dr. Colquhoun will also cover how to deal with difficult investigators and sites that are unwilling to comply with regulatory standards. A discussion will follow on the consequences of non-compliance, as well as how to prepare for a monitoring audit by the FDA. Dr. Colquhoun will also discuss how clinical research departments need to be resourced to deal adequately with monitoring demands. The presentation will be illustrated by real-life examples.

Monitoring Essentials for International Medical Device Trials is presented by Helen Colquhoun, MD, CEO, Pleiad Devices. For more details on this presentation, please visit our web site www.fxconferences.com