POSTPONED DUE TO CORONAVIRUS Drug Development: Regulatory Aspects and Clinical Trials (+CILS) - See below for modified time schedule (Zoom sessions)

Wed 01.04.2020 (Zoom SL); ; Fri 17.04.2020 + Q&A sessions during the next week (recorded .mp4 + Zoom AN); Thu 23.04.2020 (Zoom AMcA) Thu 30.04.2020 (Zoom SL) Thu 07.05.2020 (Zoom AMcA), from 13:30-17:30 - Thu 14.05.2020 (Zoom AMcA), from 13:30 - 17:30

Dr Andrés Mc Allister, AMConsulting Dr Aarti Naik, Triskel Intergrated Services, Genève; Dr Sabine Latour, Genève

To give the students an introduction on the main topics linked to setting up the clinical evaluation of a drug and preparing a dossier to be submitted to regulatory agency for approval. Introduction: Present the subject Regulatory affairs and Quality control: The students know the prerequisites for administrating a putative drug to human and thus starting clinical trials. The students know who gives the authorization to start clinical trials (ETHICS committee) and the prerequisites for obtaining such an authorization. The students know what is a patient consent form (informed-consent documents). The students know the strategy to be pursued for depositing a dossier to the regulatory bodies (internal strategy for development versus strategy guided by the regulatory guidelines). The students know what is GCP and is practical aspects Clinical study/organization: The student know how a controlled clinical study is practically planned and analyzed. The roles of the different actors, including the hospital pharmacist, are discussed Pharmacovigilance /safety: The students understand how the clinical safety profile of a drug is defined during premarketing andpostmarketing periods. The students understand the aims and the methods of passive pharmacovigilance vs. proactivepharmacovigilance (pharmacoepidemiology

UNIGE, CMU, room B02.2526 (auditoire Reverdin)

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