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BENEFIT/RISK MANAGEMENT IN PHARMACOVIGILANCE
Session Chair(s)
Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP
Director
Drug Safety Research Unit, United Kingdom
Post-Authorisation Studies for RMPs: Challenges and approaches
Learning Objective : To provide awareness of the new requirements for RM, PASS and PAES in the new EU legislation. To provide insight on not only to comply but benefit from these. Awareness of both scientific thought and practical applications.
Speaker(s)
The Risk Management Plan as a Post-Authorisation Drug Dossier- the good, the bad and the ugly
Helene Plein, PhD, MSc, RPh
Irish Medicines Board, Ireland
Human Products Vigilance assessor
Post-Authorisation Studies for RMPs: Challenges and approaches
Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP
Drug Safety Research Unit, United Kingdom
Director
Failure modes, effects and criticality analysis techniques (FMECA) to optimise risk-benefit management in Novo Nordisk A/S
Samuel Ramsden, MSc
Boehringer Ingelheim International Gmbh, Germany
Head of Risk Management Office
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