28 March 2013 - The Sources of the Pharmaceutical Law

Location: De Montil, Affligem

Language for this session: English (slides, presentations & Q&A)

13:30 Welcome to participants and introduction of the session
           Hugues Haesebroek, BRAS Education Group

13:35 European sources of pharmaceutical law (Regulation, Directives, Guidelines,
           Case law, etc.) 
           Olivier Mignolet, Simmons & Simmons LLP

14:05 Belgian sources of pharmaceutical law - part I: types of national legislations,
           legislation process and characteristics of laws and royal decrees
           Bernard Couvreur, Culture in vivo ASBL/VZW

14:35 Belgian sources of pharmaceutical law- part II: other national sources of  
           rules ; study of the structure of laws, identification of important provisions 
           and rules of interpretation
           Olivier Mignolet, Simmons & Simmons LLP

15:00 Coffee Break

15:30 Soft law: code of ethics of the industry associations, guidelines, etc.  
            Annabelle Bruyndonckx, Simmons & Simmons LLP

15:50 Practical example : the pharmacovigilance legislation
           Annabelle Bruyndonckx, Simmons & Simmons LLP

16:15 Exercises and Questions & Answers 
           Bernard Couvreur, Culture in vivo ASBL/VZW
           + All speakers for Q&A

17:00 Closing of the session
 

It is understood, to be admitted to the session, that the fees have been pre-paid. In case of cancellation after 18 March 2013, the fees are due and will be invoiced.