Effective Translation Process for Japan Regulatory Submissions

is being presented by Jason Heaton, Compliance Specialist, with ForeignExchange Translations, and airs on Wednesday, November 3rd, 2010. For more details or to register, please visit our site at www.fxconferences.com

Many companies doing business in Japan rely on their Japanese affiliates to handle the creation of regulatory documentation, due to language and cultural considerations and the complexities of Japanese regulations. A problem with this approach is that often the US-based companies then don't know exactly what was submitted to the government, which can have serious implications.

The Japan submission dossier preparation and translation process requires a unique approach. Cooperation among submission authors, the translators and the Japanese affiliate is essential to make it work. When it does, a company can be assured that its English and Japanese submissions stay consistent, and there are no questions about what is submitted. It has the side benefit of building cross-cultural teams, where both parties focus on their core competencies.

This audio conference discusses how regulatory documentation gets translated, looks at specific approaches companies take for their Japan dossier creation, identifies the problems with the usual approaches, and then presents best practices for creating consistent, accurate and timely submissions.

EMEA & Risk Management: What You Need to Know

It is vitally important that pharmaceutical and biotech companies marketing their products in Europe familiarize themselves with what the European Medicines Agency (EMEA) has to say on the subject of risk management. Do you need a risk management plan if you are using centralized procedure? How about decentralized procedure or mutual recognition? Where does risk management go in the dossier? And what sort of risk minimization will be expected?

In this audio conference, EU regulatory expert Dr. Stefan Blesse answers these and more questions about EMEA's Guideline on Risk Management Systems for Medicinal Products for Human Use, offering insight and examples as to why it should be considered a strategic opportunity, and not a threat to industry.

EMEA & Risk Management: What You Need to Know is being presented by Dr. Stefan Blesse, Principal Consultant, with Granzer Regulatory Consulting & Services and airs on Thursday, June 4, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com