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EU Regulatory Affairs Introductory Training Course

19.11.2018 - 21.11.2018

Marketing authorisation in Europe for beginners

Do you need essential European regulatory affairs knowledge? This course gives you a compact overview about all important issues. Each day may be booked separately according to your needs!

EU Regulatory Affairs Introduction Course

  • Day 1: Marketing Authorisation Procedures in Europe
  • Legal basis, Mutual recognition, decentralised and centralised procedure in detail
  • Day 2: Marketing Authorisation Documents
  • Data for the dossier, key elements and structure of the SmPC and the package leaflet
  • Day 3: Regulatory Life Cycle Management
  • Variations, Renewals, eCTD and electronic submission

This distinguishes our event

Overall impression: 100% of the participants’ feedback was very good or good. (November 2017)

Course content: 100% of the participants’ feedback was very good or good. (November 2017)

Practical benefit: 100% of the participants’ feedback was very good or good. (November 2017)

100% of the participants say that the course met their expectations. (November 2017)

EU Regulatory Affairs Introduction Course

This introductory training course will inform you about all the important obligations and challenges in regulatory affairs. You will learn about the different procedures in Europe and about the data and documents required for successful marketing authorisations. Moreover, you will gain practical knowledge about the regulatory life cycle management for a product and the structure and submission of an electronic dossier.

Who should attend

This seminar will be of benefit to all those working in regulatory affairs or in related departments that need essential European regulatory affairs expertise. Basic pharmaceutical knowledge is recommended but not prerequisite.

Veranstaltungsort

Amsterdam Marriott Hotel
Stadhouderskade 12
NL 1054 Amsterdam

Veranstalter

FORUM Institut für Management GmbH

Sträter Rechtsanwälte
Kronprinzenstraße 20
D-53173 Bonn

Fon +49 (0) 228 93454-0
Fax +49 (0) 228 93454-54

mail(at)straeterlawyers.de

Referent

Dr. Christian Moers

Rechtsanwalt Dr. Moers ist seit 2013 Mitglied der Kanzlei und berät pharmazeutische Unternehmen im Bereich der Zulassung und des Vertriebs von Arzneimitteln, Pharmakovigilanz, Großhandel mit Arzneimitteln und Arzneimittelherstellung.

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