FORUM INSTITUT

FORUM · Institut für Management GmbH
Vangerowstraße 18
69115 Heidelberg
E-Mail: service@forum-institut.de
Telefon: +49 6221 500-500
Fax: +49 6221 500-505
teaser

Regulatory Leaders FORUM

Regulatory Intelligence &
Regulatory Information Management

2017-09-29 2017-09-29 NH Collection Berlin Friedrichstrasse Friedrichstr. 96 10117 Berlin nhfriedrichstrasse@nh-hotels.com +49 30 206266-0 +49 30 206266933

Regulatory Leaders FORUM

Regulatory Intelligence and Regulatory Information Management

For all who carry responsibility in regulatory affairs with hands-on expertise, including practical examples and projects

Topics

  • Regulatory pathways in the context of unmet medical needs
  • Real World Evidence in the authority's approval
  • From national to international: collaboration of authorities 2020
  • Digital product information - Project GI 4.0
  • eCTD and eSubmission - always and everywhere?
  • SPOR areas and regulatory information management

Aims and objectives

Do you have years of regulatory affairs experience and carry great responsibility in regulatory affairs? Then, you should not miss the Regulatory Leaders FORUM, where regulatory affairs experts from the industry and from European authorities will provide you with insights into their daily affairs, including practical case studies.

You will leave the conference with new ideas on how to successfully deal with upcoming challenges such as early access schemes, the inclusion of RWE data in marketing authorisations, digital product information and eSubmission requirements.

Since the requirements for eSubmission and IDMP in the SPOR areas are especially challenging, day two will be completely dedicated to these issues. If these issues are not personal priorities, it is possible to attend only day one.

I look forward to meeting you at the conference.

Yours faithfully
Dr Henriette Wolf-Klein
Department Manager Healthcare

Who should attend?

This conference addresses the needs of people working in the pharmaceutical industry who carry responsibility in a regulatory position. The meeting will mainly focus on EU regulatory challenges, but will also include global regulatory issues.

Day two focuses on eCTD, eSubmission, IDMP and the SPOR areas, and can be booked separately.

Your speakers

Chairs
Dr. Maren von Fritschen
AddOn Pharma GmbH, Berlin, GERMANY - Chair, day one -

Dr. Klaus Menges
Senior Expert in Regulatory Affairs, Bonn, GERMANY - Chair, day two -

Speakers, day one
Dr. Peter Bachmann
Senior Expert Regulatory Affairs, Bonn, GERMANY

Dr. Gesine Bejeuhr
German Association of Research-based Pharmaceutical Companies (vfa e.V.), Berlin, GERMANY

Dr. Ulrich Granzer
Granzer Regulatory Consulting & Services, Munich, GERMANY

Anne Lenihan
Pfizer Pharmaceuticals, London, GREAT BRITAIN

Dr. Isabelle Stöckert
Bayer AG, Wuppertal, GERMANY

Martine Zimmermann
Alexion Pharma GmbH, Zürich, SWITZERLAND


Speakers, day two
Dr. Rüdiger Faust
Grünenthal GmbH, Aachen, GERMANY

Mickel Hedemand
Danish Medicines Agency Medicines Licensing & Availability, Workflow, Copenhagen, DENMARK

Georg Neuwirther
AGES Austrian Medicines and Medical Devices Agency, Vienna, AUSTRIA


Go forward

Our international course portfolio

Are you interested in our international continuous education programme?

We provide a variety of specialised courses for the healthcare industry.

Details

Testimonials

Hear from our past delegates and sponsors and learn more about the events.

Details

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 10.2015 - 09.2016 produced a result of 1.7 (based on a school grading system of 1-6).

Details