Symposia1

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  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 Catherine Meyzonnier, Hospices Civils de Lyon, France

10h30 -11h00 coffee break

  11h00 – 11h30 Management of risk: a pharmaceutical company’s view Elisabeth Loupi, Aventis-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, MDS 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

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