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2012225 Seminar Webcast Series: Legal Issues in Regulatory Affairs
Webcast Series: Legal Issues in Regulatory Affairs
2020-01-26 2020-01-26 Online Online

Webcast Series: Legal Issues in Regulatory Affairs

Essential legal expertise for your marketing authorisation and product maintenance duties

These recorded six webcasts enable you to deal with the legal challenges in marketing authorisation and life cycle management.
  • Legal basis for marketing authorisations
  • Dealing with deadlines, conditions, etc.
  • Orphan drugs and paediatric development
  • Preparing for referrals
  • Contracts in regulatory affairs
  • IP and generics development

Aims and objectives

This recorded webcast series focuses on the main legal challenges in regulatory affairs. Participants will get a thorough understanding of the legal impact of processes in the marketing authorisation phase as well as throughout the life cycle.
Who should attend
This recorded webcast series is intended for regulatory affairs professionals in pharmaceutical companies. It will also benefit legal affairs staff, familiarising them with legal challenges in regulatory affairs.
Your speakers
Prof. Dr. Kerstin Brixius
Professor for administrative, european and constitutional law, University of Applied Sciences for Public Administration and Management of North Rhine-Westphalia, Germany

Christian Karle
KOZIANKA & WEIDNER Lawyers, Hamburg, Germany

Dr. Christian M. Moers
Sträter Lawyers, Bonn, Germany

Dr. Alexander Natz, LL.M.
EUCOPE - European Confederation of Pharmaceutical Entrepreneurs, Brussels, Belgium

Sita Schubert
COMM-OP Europe GmbH & Co. KG, Dusseldorf

Prof. Burkhard Sträter
Sträter Lawyers, Bonn, Germany

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More on our quality criteria

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IMI (Innovative Medicines Initiative) defined quality criteria for professional training and education. We follow these criteria and, as a signatory, we are an active partner in further developing and optimising the quality standards.

An aggregate evaluation of participants' feedback on all FORUM's healthcare training courses (evaluation period from 01.2019 - 12.2019) produced a result of 1.6 (where 1 is the highest grade and 6 the lowest).