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.