Regulatory Experts Meet in Mannheim

At the beginning of March, members of the Working Group on Regulatory Matters met in Mannheim to discuss the group’s future strategic direction. However, the first item on the agenda was a welcome to Edgar Fenzl, the new co-chairman of the group, by Markus Hofbauer. Fenzl takes over from Peter Buckel, who recently retired.

The experts discussed the status of the topics it addressed in 2012 and 2013 and compared the work of the past years with the topics listed as priorities in the 2011 member survey. In 2014, the working group will follow the implementation of the new EU Clinical Trials Directive (on medicinal products for human use). It also plans to provide BIO Deutschland members with an overview of the major changes and help in switching to the new system. In addition, the working group will deal with the following topics:

• Medicinal products for innovative therapies
• Contracts for principal investigators
• Personalised medicine
• Regulatory requirements in the e-health sector

The working group has already scheduled its meetings for 2014. The next meeting will take place in Munich in the second week of June, while a third meeting is planned for the first day of BioEurope in Frankfurt on Main.