1. Prof. A. De Wever SAFETY, EFFICACY, QUALITY AND RISK/BENFIT RATIO Source : Marc Czarka

2. Prof. A. De Wever  Two regulatory bodies  one to regulate the public financing  one to regulate the safety, efficacy, quality and risk/benefit ratio Why laws and regulations ?

3. Prof. A. De Wever TIMELINES Pure Food and Drug Act 1906 Numerous health scandals 1938 Food, Drug and Cosmetic Act Sulfanilamide syrop scandal SAFETY 1927 FDA est. Why laws and regulations ?

4. Prof. A. De Wever TIMELINES Creation of nat’l regulatory bodies in Europe 1961 Thalidomide Nuremberg Code 1949 WWII “medical” experiments Kefauver- Harris Amendments 19621950’s Creation of Japanese regulatory body SAFETY AND EFFICACY PROTECTION OF HUMAN SUBJECTS Why laws and regulations ?

5. Prof. A. De Wever Why laws and regulations ? TIMELINES Towards some harmonisation within the EEC EEC directive 65/65/EC 19651964 Declaration of Helsinki ICH 1990 Towards more global harmonisation 1981 GCP/FDA PROTECTION OF HUMAN SUBJECTS

6. Prof. A. De Wever TIMELINES European directive 2002/… on clinical trials 2002 Towards more harmonisation within the EU What’s next? ?1995 Creation of the EMEA Towards more harmonisation within the EU PROTECTION OF HUMAN SUBJECTS Why laws and regulations ?

7. Prof. A. De Wever FDA's Mission Statement The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. Why laws and regulations ?

8. Prof. A. De Wever FDA's Mission Statement The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. http://www.fda.gov/opacom/morechoices/mission.html accessed on 18APR2004 http://www.fda.gov/opacom/morechoices/mission.html accessed on 18APR2004 Why laws and regulations ?

9. Prof. A. De Wever EMEA Mission Statement To contribute to the protection and promotion of public and animal health by :  Mobilising scientific resources from throughout the European Union to provide high quality evaluation of medicinal products, to advise on research and development programmes and to provide useful and clear information to users and health professionals. Why laws and regulations ?

10. Prof. A. De Wever EMEA Mission Statement  Developing efficient and transparent procedures to allow timely access by users to innovative medicines through a single European marketing authorisation.  Controlling the safety of medicines for humans and animals, in particular through a pharmacovigilance network and the establishment of safe limits for residues in food-producing animals. http://www.emea.eu.int/# accessed on 18APR2004 Why laws and regulations ?

11. The healthcare professionals magazine 6x/year - FR/NL 8.000 readers —————————— Hot topics seminars driven by reknown opinion leaders