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Content :
Research & Development Quality
For research and development activities, national and international health authority agencies monitor the compliance of development activities with Good Practice regulations in effect: - at our development sites
- at our subsidiaries' clinical research units;
- for our subcontractors (Contract Research Organizations, or CROs) and centers of clinical investigations.
Research & Development Quality| | Preclinical | Preclinical | Clinical |
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| Activity | Chemical and Pharmaceutical | Non-Clinical Safety Studies | Clinical and Pharmacovigilance |
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| Good Practices | Good Manufacturing Practices (G.M.P) | Good Laboratory Practices (G.L.P) | Good Clinical Practices (G.C.P) |
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| Practices monitored | - Chemical synthesis
- Analytical science
- Pharmaceutical science
- Products for clinical trials
| - Toxicology
- Safety pharmacology
- Metabolism and pharmacokinetics
- Analytical science
- Laboratory animal science and ethics
| - Clinical development
- Pharmacovigilance (pre- and post- marketing)
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| Inspections by authorities in 2006 | Total of 9 by local authorities:
- 3 by the AFSSAPS in France
- 3 by the German health authorities (1 in Germany, 2 in the United States)
- 1 by the M.H.R.A in the U.K;
- 1 by the Saudi Health Authority in Germany;
- 1 by the the Korean F.D.A, in Germany
| Total of 8
- 2 by the AFSSAPS in France;
- 1 by the Pharmaceuticals and Medical Devices Agency (P.M.D.A) in Japan
- 1 by the Medicines and Healthcare Products regulatory Agency (M.H.R.A) in the UK;
- 2 by the Hungarian authorities (NIP) in Hungary
- 1 by the F.D.A in the US
- 1 by the German authorities in Germany
| Total of 52
- 15 by the European authorities;
- 20 by the F.D.A (U.S.A)
- 9 by the P.M.D.A (Japan)
- 8 by other authorities
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