New CfPIE Training Courses Detail EU Compliance Strategies
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|Thursday, 08 August 2013 15:00 (UTC + 2)|
For European media only
Agendas focus on strengthening regulatory awareness for pharmaceutical and biotechnology professionals in Europe
Malvern, PA, USA, August 8, 2013 / B3C newswire / - The Center for Professional Innovation and Education (CfPIE) has announced two new EU regulations training courses for life science professionals. The new courses – to be presented in early December at the Berlin Hilton in Berlin, Germany, expands upon the thirty other CfPIE courses presented in Europe each year.
The course, “European Union Regulatory Issues - New Product Development”, outlines current regulatory strategy concerns, scientific advice, orphan medicines and paediatric development plans. Those involved in new product development as well as those seeking to update their knowledge of European Medicines Agency (EMA) regulatory changes will benefit from the course.
A second course, “Filing Variations in the European Union”, focuses on the rules and procedures for filing variations and extensions. It addresses those issues from a comprehensive perspective as well as in relation to new regulations for national marketing authorisations and work sharing, which went into effect on 4 August 2013.
Course director, Adriaan Fruijtier, will provide insights and share best practices from his Regulatory Affairs experience at Bayer AG, Bayer Corporation, the European Medicines Agency, Micromet AG, Novartis AG, and Ciba-Geigy. Adriaan states “I am very excited to deliver these new courses. With my extensive industry experience, I can provide a comprehensive overview of the expectations regulatory authorities have. Both courses are very timely, as regulations regarding the development of new medicinal products are ever changing, and new regulations regarding the variations have just come into effect.”