On Friday, November 23th 2012 BeAPP and pharma.be organises an information session titled ?Be (pharmaco) vigilant! Important changes in the PV- legislation?. Programme 13h-13h10: Introduction. L. Neels GOVERNANCE IN POST-MARKETING PHARMACOVIGILANCE ? Speakers introduction and chairman: S. Vancayzeele 13h10-13h30: Does a safe legal environment guaranty safety? An industry perspective. Impact on ?SME?s? M. Sangeleer B. De Greef ? K. Vandeweyer 13h30-13h45: Before and after 1235. Legislation review. Th. Roisin 13h45-14h00: How to smoothen the transition period? EU and Belgian bridging measures. S. Goethals 14h00-14h30: How to qualify for quality in the near future and be audit ready ? N. Matthijs 14h30-14h45: The Belgian consensus on Risk Minimisation Activities. New process. ML . Bouffioux 14h45-15h05: Questions and Answers. BREAK till 15h30 GOVERNANCE IN INVESTIGATIONAL PRODUCTS SAFETY ? Speakers introduction and chairman: S. Vancayzeele 15h30-15h45: Does CT3 provide more operational transparency? An industry perspective. J. Van Rampelbergh 15h45-16h: The Belgian implementation of CT3 (circ. 586 & DSURs). K. Bonnarens 16h 16h15: How to qualify for quality in IMP safety in the near future? S. T?Kindt 16h15-16h30: Questions and answers. 16h30-16h45: Priorities of the DGs in the near future and take away messages. V. Biname ?G. Musch-J. Van der Elst 16h45-16h50: Conclusions L. Neels WALKING COCKTAIL till 17h30