Drug development: regulatory aspects and clinical trials (+CILS)

Dernière session (remplacement de la session du 10.04) JYLC: 18.05 de 13:30 à 16:30

Leonardo Scapozza, PO, sciences pharmaceutiques, UNIGE

Dr Andrés Mc Allister, AMConsulting; Dr Jean-Yves Le Cotonnec, 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.

Structure of the course

lesson 1 Introduction Andrés Mc Allister

lesson 2 Pharmacovigilance /safety Andrés Mc Allister

lesson 3 Clinical protocols 1 Andrés Mc Allister

lesson 4 Clinical protocols 2 Andrés Mc Allister

lesson 5 Regulatory affairs and Quality control Jean-Yves Le Cotonnec (J-YleC)

lesson 6 Regulatory affairs and Quality control Jean-Yves Le Cotonnec (J-YleC)

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/organizatio 4 Sabine Latour (SL)

Endpoints for single modules

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)

CMU A04.3011 for 21.02 and 28.03 sessions, room B04.1522 for 09.03, room A04.2906 for 22.03 session, 10.04 : room A04.3011

12