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FRIDAY JULY 6th


22nd FRENCH MEETING OF PHARMACOVIGILANCE

  9h15 – 9h30 Welcome address:
Jean-Pierre Blayac (President of the French Association of Regional Pharmacovigilance Centres)
RISK AND PHARMACOVIGILANCE (9h30 – 12h30)
  9h30 – 10h00 Sociological aspects of risk
Michel Setbon Ecole Normale Supérieure, Cachan, France
  10h00 – 10h30 Risk management and quality: the viewpoint of a general hospital administration
Michel Setbon Ecole Normale Supérieure, Cachan, France
  10h30 – 11h00
Coffee break
  11h00 – 11h30 Management of a risk: a pharmaceutical company’s view
Elisabeth Loupi Adventis-Pasteur, Lyon, France
  11h30 – 12h00 Pharmacovigilance and the precautionary principle
Philippe Duneton AFSSAPS, Saint-Denis, France
  12h00 – 12h30 Perception of risk and drugs
Bernard Bégaud Université de Bordeaux II, France
DRUGS IN PREGNANCY: RISK ASSESSMENT AND MANAGEMENT (14h00 – 17h30)
  14h00 – 14h30 Preclinical testing for teratogenicity and developmental toxicity: methods and limitations
Paul Barrow MSD, Pharma Services, L’Arbresle, France
  14h30 – 15h00 Assessment of risks related to drug exposure during pregnancy: advantages, limitations and interpretation of results drawn from new epidemiological study designs
Elisabeth Robert Institut Européen des Génomutations, Lyon, France
  15h00 – 15h30 Long-term psychiatric and behavioural consequences of prenatal exposure to drugs
Hélène Verdoux Université de Bordeaux II, France
  15h30 – 16h00
Coffee break
  16h00 – 16h30 Randomized clinical trials during pregnancy
Gérard Bréart INSERM, U149, Paris, France
  16h30 – 17h00 Legal aspects of Pharmacovigilance Officer’s communication to the health care professionals – Consequences in the field of teratology
Jean-Paul Demarez Institut de Recherche Pierre-Fabre, Boulogne, France
  17h00 – 17h30 From risk classification to labelling of the pregnancy section in the SPC. The French experience
Elisabeth Elefant Centre de Renseignement sur les Agents Tératogènes, Faculté de Médecine Saint-Antoine, Paris, France, France

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