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Titre

Drug Development: Regulatory Aspects and Clinical Trials (+CILS)

Dates

22.02.2019 room A04.2713; 14.03.2019 room A04.2713; 28.03.2019 room A04.2713; 11.04.2019 room B01.2426 (Renold); 09.05.2018 room A04.2713; 23.05.2019 room A04.2713; 13:00-16:45

Organisateur(s)/trice(s)
Intervenant-e-s

Dr Andrés Mc Allister, AMConsulting, Genève

Dre Aarti Naik, Triskel Intergrated Services, Genève;

Dre Sabine Latour, Genève

Description

 

Objectives:  

 

To give the students an introduction to drug development from drug discovery through to marketing, focusing on steps involved in the clinical evaluation of safety and efficacy of drug candidates, the approval and marketing of medicines, and post-marketing commitments of pharmaceutical companies. .

 

 

 

Course Outline:  

 

· 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 aspects of drug development and approval (Aarti Naik)

 

 · lesson 6 Products on the Borderline: Opportunity and Challenges (Aarti Naik / Melinda Friend)

 

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

 

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

 

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

 

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

 

 

Endpoints for single modules:

 

Pharmacovigilance /safety:

 

The students understand how the clinical safety profile of a drug is defined during premarketing and postmarketing periods

 

The students understand the aims and the methods of passive pharmacovigilance vs. proactive pharmacovigilance (pharmacoepidemiology).

 

Clinical study/organization:

 

The students know how a controlled clinical study is planned, performed and monitored

 

The roles of the different actors, including the hospital pharmacist, are discussed

 

The students know what is meant by Good Clinical Practice (GCP)

 

The students know what a patient consent form is (informed-consent documents)

Regulatory aspects of drug development and approval:

 

 Students will:

 

- understand the role of regulatory agencies in the development, approval and post-marketing lifecycle of medicines

 

- learn about fundamental European legislation governing the use of medicinal products in humans

 

- understand how medicines are approved in Europe and about different licensing procedures available in Europe

 

- learn about the content and format of a dossier ("marketing authorisation application") necessary for obtaining approval for medicines from regulatory agencies. Some illustrative examples will be presented in terms of roles or regulatory (and regulatory lawyer's) in guiding R&D and marketing teams during product development and marketing.

 

-learn about "borderline products", i.e. products which can be regulated as a drug (usually OTC) or medical device or biocide or dietary supplement or cosmetic, depending largely on claims and presentation. A comparison between regulatory product definitions will be presented along with their associated regulatory frameworks, designed (more or less) to control risks inherent with a particular type of product.

 

 

 

 

 

 

 

Lieu

Genève, CMU

Information
Places

20

Délai d'inscription 07.02.2019
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