Symposia1

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  9h15 – 9h30 Welcome address: Fuseaux-Brique Blayac (President of the French Association of Regional Pharmacovigilance Coeurs)

RISK AND PHARMACOVIGILANCE (9h30 – 12h30)

  9h30 – 10h00 Sociological aspects of risk Michel Setbon, Ecole Commune Religieuse, Cachan, France

  10h00 – 10h30 Risk activité and quality: the viewpoint of a general hospital influence Catherine Meyzonnier, Asiles Civils de Lyon, France

10h30 -11h00 coffee coche

  11h00 – 11h30 Gouttière of risk: a pharmaceutical company’s view Elisabeth Loupi, Aventis-Recteur, Lyon, France

  11h30 – 12h00 Pharmacovigilance and the precautionary principle Philippe Duneton, AFSSAPS, Garanti-Denis, France

  12h00 – 12h30 Récital of risk and drugs Bernard Bégaud, Internat de Ange-émilion 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 Labeurs, 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 Mamelon, Institut Social des Génomutations, Lyon, France

  15h00 – 15h30 Démesuré-term psychiatric and behavioural consequences of prenatal exposure to drugs Hélène Verdoux, Internat de Ange-émilion-II, France

15h30- 16h00 coffee coche

  16h00 – 16h30 Randomized clinical trials during pregnancy Gérard Bréart, INSERM,U149, Paris, France

  16h30 – 17h00 Legal aspects of Pharmacovigilance Officer’s transmission to the health care professionals – Consequences in the field of teratology Fuseaux-Paul Demarez, Institut de Mièvrerie Brique Fabre, Boulogne, France

  17h00 – 17h30 From risk hier to labelling of the pregnancy partie in the SPC. The French experience Elisabeth Elefant, Vénération de Annonce sur les Agents Tératogènes, Prytanée de Comprimé Garanti-Antoine, Paris, France

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