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Regulatory Affairs

Testimonials

"The Regulatory Affairs course is very well structured, with detailed information about the Swiss and international regulatory fields. The gained knowledge is highly useful and applicable to the daily work."

Dr. Sandrine Beier, Manager Regulatory Affairs, TRB Chemedica International SA


Dr
Dr. Sandrine Beier



Scope

This course provides an integrated view of drug regulation in the US, Europe and Switzerland. The goal is to offer an introduction to regulatory affairs in order to understand the legal basis and its implications for drug development and production.

In particular, the following topics will be covered: organization of European and Swiss authorities and their main regulations, the implications of drug regulation for pharmaceutical and clinical development, marketing authorization procedures and post-marketing procedures. Furthermore the course will teach particularities of drug regulation in Switzerland and the respective adaptation of regulatory documents.

Regulatory aspects of special medicinal products such as generics, biosimilars, orphan and herbal medicinal products will also be highlighted.

The speakers include experts from industry, consulting and the health authorities.

Audience

The course addresses individuals with a degree in pharmacy, medicine or natural sciences who work in the pharmaceutical or a related industry or for a service provider in this field. In particular:

Topics and speakers 2013

Opening lecture:

Regulatory aspects of drug development

Dr. L. Ham, F. Hoffmann-La Roche
European and US regulations for medicinal products, ICH, Marketing authorisation Dr. F. Wierckx, PFC
FDA regulations
G. Maitra, AC Immune
Pharmacovigilance K. Hartmann, Crucell
Clinical trial directives and application procedures
Dr. B. Happ
Health economics and outcomes research
Dr. M. Olson, Novartis
Swiss authorities and regulations C. Landgraf, Swissmedic
Helvetisation of regulatory documents
Dr. B. Zimmerli Matter, PCR
Special regulations: Biologics
Dr. L. Ham, F. Hoffmann-La Roche
Special regulations: Generics
Dr. D. Heer, Armeeapotheke
Special regulations: Biosimilars
Dr. U. Gosslar, Sandoz
Special regulations: Orphan Drugs
Dr. B. Happ
Special regulations: Paediatrics S. Capo Chichi, Roche
Special regulations: Herbal Medicinal Products Dr. C. Halbsguth, Max Zeller Söhne AG
Variations and change control
Dr. D. Brandt, Acino Pharma
Electronic submission
Dr. M. Braun, Exalon GmbH
Life Cycle Management
Dr. K.-H. Loebel, Pharmalex
   
Workshop :

How to search the web for regulatory information

Dr. D. Heer, Armeeapotheke

Course language

English

Dates

planned for 2015 (5 days)

from 9 am to 5 pm

Course location

Pharmacy museum, Totengässlein, Basel, University of Basel

Course fee

CHF 2500.-
reduced price for PhD students

Application

Application Form »»

 

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© 2014 ETH Zurich | Imprint | Disclaimer | 25 June 2013
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