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SAFETY, EFFICACY, QUALITY AND RISK/BENFIT RATIO

SAFETY, EFFICACY, QUALITY AND RISK/BENFIT RATIO Source : Marc Czarka. Why laws and regulations ?. f Two regulatory bodies w one to regulate the public financing

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SAFETY, EFFICACY, QUALITY AND RISK/BENFIT RATIO

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  1. SAFETY, EFFICACY, QUALITY AND RISK/BENFIT RATIO Source : Marc Czarka

  2. Why laws and regulations ? f Two regulatory bodies • wone to regulate the public financing • wone to regulate the safety, efficacy, quality and risk/benefit ratio

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

  4. 1949 1950’s 1961 1962 Nuremberg Code Creation of Japanese regulatory body Creation of nat’l regulatory bodies in Europe Kefauver-Harris Amendments WWII “medical” experiments Thalidomide SAFETY AND EFFICACY Why laws and regulations ? TIMELINES PROTECTION OF HUMAN SUBJECTS

  5. 1964 1981 1965 1990 Declaration of Helsinki GCP/FDA EEC directive 65/65/EC ICH Towards some harmonisation within the EEC Towards more global harmonisation PROTECTION OF HUMAN SUBJECTS Why laws and regulations ? TIMELINES

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

  7. Why laws and regulations ? 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.

  8. Why laws and regulations ? 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

  9. Why laws and regulations ? EMEA Mission Statement To contribute to the protection and promotion of public and animal health by : f 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.

  10. Why laws and regulations ? EMEA Mission Statement f Developing efficient and transparent procedures to allow timely access by users to innovative medicines through a single European marketing authorisation. f 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

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

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