FORUM INSTITUT
FORUM · Institut für Management GmbH
Vangerowstraße 18
69115 Heidelberg
Email: service@forum-institut.de
Phone: +49 6221 500-500
Fax: +49 6221 500-505
Course Regulatory Affairs Winter School
Regulatory Affairs
Winter School
2018-12-16 2019-01-18 Mercure Hotel & Residenz Frankfurt Messe Voltastr. 29 60486 Frankfurt h1204@accor.com +49 69 7926-0 +49 69 7926-1606

Regulatory Affairs Winter School

Focus on EU procedures, regulatory documents, submission duties and life cycle management

This three-day winter school provides a thorough update on EU procedures, regulatory documents, submission duties and life cycle management.
Topics
  • NCEs and NBEs - Regulatory strategy for the EU and US
  • Known substances - Repurposing and repositioning
  • Quality and CMC - Assuring regulatory compliance
  • Variations, line extensions and repeat use
  • eSubmission - eCTD and SPOR
  • Labelling, artwork and serialisation

Aims and objectives

This winter school provides a thorough update on EU procedures, regulatory documents, submission duties and life cycle management. It also addresses the interfaces with production, medical affairs and pharmacovigilance.

After having attended this winter school, you will be more comfortable defining your own regulatory strategy and setting your product on its way to marketing authorisation in the EU. You will know how to submit your documents and how to maximise your product life cycle. You will also be able to collaborate professionally with production, medical affairs and pharmacovigilance.

Who should attend
This winter school addresses the needs of regulatory affairs (RA) specialists and managers in the pharmaceutical industry, as well as service providers. Co-workers in neighbouring departments will also benefit from insights into RA activities. A basic understanding of RA is a prerequisite for this training.

Our introductory e-learning courses on procedures and regulatory documents would fulfil this requirement.
Your speakers
Your speakers day 1
Dr. Stefan Blesse
Granzer Regulatory Consulting & Services, Munich

Dr. Heike Busse
PharmaLex GmbH, Friedrichsdorf

Dr. Kirsten Plaßmann
Lawyer Stuttgart, Germany

Your speakers day 2
Mariela Becker, M.D.R.A.
Senior Expert in Regulatory Affairs, Bonn

Dr. Regina Heckenberger
Bayer AG, Wuppertal

Karl-Heinz Loebel
PharmaLex GmbH, Mannheim


Your speakers day 3
Christian Karle
KOZIANKA & WEIDNER Rechtsanwälte, Hamburg

Martina Ullrich
Fresenius Medical Care Deutschland GmbH, Bad Homburg


Go forward

International events

Our international course portfolio

Are you interested in our international continuous education programme? We provide a variety of specialised courses for the healthcare industry.

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Abbreviations, Glossary

List of abbreviations

Many abbreviations for processes, documents and authorities, amongst others, are used in all regulatory areas. We have compiled the most important ones for you.

Our list of abbreviations can be freely downloaded here.

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More on our quality criteria

Quality guaranteed!

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 10.2017 - 09.2018 produced a result of 1.6 (based on a school grading system of 1-6).

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