Safety & Regulation in Early Clinical Drug Development, 02-Dec-2016


The BAPU (Belgian Association of Phase I Units) board is pleased to invite you to the BAPU Symposium: “Safety & Regulation in Early Clinical Drug Development”, which will take place on Friday December 2, 2016 at the Marriot Hotel in Gent.

Please find enclosed the programme, registration information and address. Last registration date is Friday, November 11.

Friday, December 2nd, 2016

  • 12:30 Registration and Coffee
  • 13:30 Introduction by the BAPU Chairman Delphine Malisse

Part I: Safety Aspects in Early Clinical Development

Chair: Jan de Hoon, Annick Van Riel

  • 13:40 What makes FAAH so attractive as a CNS target? From bench to clinic. Mark Schmidt, Johnson & Johnson
  • 14:20 The BIAL 10-2474 Accident: Investigator Site Perspective. Alain Patat, Biotrial, France
  • 15:00 Safety Aspects in Phase I Clinical Research: Regulator’s perspective and Recommendations. Walter Janssens, FAHMP
  • 15:30 Panel discussion. Walter Janssens, Mark Schmidt, Alain Patat, Jan De Hoon
  • 16:00 Coffee Break

Part II: EU Regulation – most recent updates

Chair: Sylvie Rottey

  • 16:30 EU Regulation: Considerations on Implementation and effects on Early Clinical Research. Diane Kleinermans, Ministry of Health
  • 17:15 Discussion. Diane Kleinermans, Sylvie Rottey
  • 17:30 Goodbye and Reception

Programme and registration information

See also the BAPU Web site.


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