Drug Development: Regulatory Aspects and Clinical Trials

Session 1&2: AMcA, Feb.25th; Session 3&4: AMcA, March 11th; Session 5&6: SL, March 25th; Session 7&8: AN, April 15th; Session 9&10: SL, May 27th; Wrap-up Session: AMcA, June 10 From 13:30-17:30

Dr Andrés Mc Allister, BioInvent.com

Dr Aarti Naik, ADC Therapeutics, Lausanne

Dr Sabine Latour, OFSP, cellule de crise COVID-19

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. Endpoints for single modules

Structure of the course

lesson 1 Introduction Andrès Mc Allister

lesson 2 Pharmacovigilance /safety Andrès Mc Allister

lesson 3 Clinical protocols 1 Andrès Mc Allister

lesson 4 Clinical protocols 2 Andrès Mc Allister

lesson 5 Regulatory affairs and Quality control Aarti Naik (AN)

lesson 6 Regulatory affairs and Quality control Aarti Naik (AN)

lesson 7 Clinical study/organization 1 Sabine Latour (SL)

lesson 8 Clinical study/organization 2 Sabine Latour (SL)

lesson 9 Clinical study/organization 3 Sabine Latour (SL)

lesson 10 Clinical study/organization 4 Sabine Latour (SL)

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 (pharmacoepidemiol

Zoom session /UNIGE if possible

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