NEW in Brussels!
The event will offer you the opportunity to network with your peers, key industry regulators and expert lawyers, whilst learning about the most recent and significant industry developments to keep you up-to-date and competitive!
Gain Practical Insights on…:
•Interpreting the Pharmacovigilance rules and the impact on reporting obligations
•The inclusion of environmental aspects into the EU legislation on Good Manufacturing Practice (GMP)
•Obtaining and maintaining an effective pricing and reimbursement structure
•The interaction between competition law and pharma regulatory requirements
•The do’s and don’ts in multi-jurisdiction clinical trials: where are we and where are we going?
•Adopting an effective product labelling model to combat anti-counterfeitinG
•The rise in social media: balancing information to patients and advertising to ensure compliance
•The approach to labelling negotiations and product liability litigation in Europe and the US
•The current US approval process in light of recent regulatory and legislative developments
•Successfully obtaining SPCs and extensions of Regulatory Data Protection: Extending your market exclusivity
Our outstanding speaker faculty includes:
•Dr. Joachim Schwerin, Head of Competition Team, DG Enterprise and Industry, European Commission (Belgium)
•Dr. Janice Soreth, Deputy Director, Europe Office, US Food & Drug Administration (UK) (provisionally confirmed)
•Dr. Alexander Natz, Head of Brussels Office, Federation of Pharmaceutical Industry (Belgium)
•Charlotte Unger, Scientific Director Environment, Medical Products Agency (Sweden)
•Ilaria Passarani, Senior Health Policy Officer, The European Consumers' Organisation (Belgium)
•John Chave, Secretary General, Pharmaceutical Group of the European Union (Germany)
Visit us online at http://www.c5-