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
CMC Documentation & Variations
Here you'll get an in-depth
quality regulatory update!
2018-12-01 2019-07-02 Welcome Hotel Frankfurt Leonardo-Da-Vinci-Allee 2 60486 Frankfurt info.fra@welcome-hotels.com +49 69 770670-0 +49 69 770670-444

Annual CMC Conference

Regulatory Update, practical aspects and current challenges in 2019

This conference addresses quality-related questions from the CTD compilation to quality changes/variations.
Topics
  • QbD elements in manufacturing
  • Impurities in active substances - Lessons learned from Valsartan
  • Revisions of CEPs
  • ICH Q12 - less burden due to quality related changes?
  • Comparative assessment of quality attributes - Statistical opportunities
  • Workshop: Quality related changes
  • Quality requirements of medicinal products containing a device component

This distinguishes our event

100%
Overall impression: 100 % of the participants' feedback was very good or good (March 2017)
100%
Course content: 100 % of the participants' feedback was very good or good (March 2017)

Aims and objectives

Do you work in regulatory affairs/CMC or quality assurance?
Then you shouldn’t miss out on this event. This conference will address very practical questions and provide strategic information on future CMC trends.

Join the in-depth discussion on new developments, including:
  • QbD elements
  • CEP
  • ICH Q12
  • Statistical opportunities
  • and much more.

I very much look forward to seeing you at the conference!

Kind regards,
Laura Vogelmann
Conference Manager Pharma & Healthcare

Who should attend
This conference will be of interest to anyone working in the pharmaceutical industry and dealing with CMC issues. Those working in the following departments will particularly benefit from this event:

  • Marketing authorisation/regulatory affairs/CMC
  • Quality assurance/quality control/analytics
  • Production
Your speakers
Chairs:
Dr. Cornelia Nopitsch-Mai
Expert for pharmaceutical quality and regulatory affairs, Bonn, GERMANY

Your speakers on Day 1:
Dr. Sandra Hürtgen
HWI ANALYTIK GmbH, Rülzheim

Dr. Lorenz Liesum
Novartis Pharma AG, Werk Rosental, Basel

Dr Andrew McMath
European Directorate for the Quality of Medicines & Healthcare - (EDQM - Council of Europe), Strasbourg, FRANCE

Susanne Weber
Merck KGaA, Darmstadt, GERMANY


Your speakers on Day 2:
Dr. Jean-Louis Robert
Laboratoire National de Santé

Dr. Christian Schübel
i.DRAS GmbH, Planegg/Martinsried


Go forward

Our international course portfolio

Our international course portfolio

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

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

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