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Seminar Pharma - CMC Writing and Submission
How to tell the
reviewer a 'good story'
2019-10-11 2019-10-11 Hotel Stadtpalais Deutz-Kalker-Str. 52 50679 Köln hotel@hotelstadtpalais.de +49 221 8 80 42-0 +49 221 8 80 42-44 44

CMC Documents: Scientific Writing for Regulatory Submission

Update your CMC English writing skills - with many practical exercises!

How to write the Module 3 for Regulatory Submission.
Topics
  • CMC Writing: key elements and mandatory requirements
  • Structure and presentation of Module 3 and the Quality Overall Summary
  • English writing skills
  • Avoiding common language pitfalls
  • Cross-checking and avoiding questions from Health Authorities

This distinguishes our event

100%
Overall impression: 100 % of the participants feedback was very good or good (October 2018)
100%
Seminar content: 100 % of the participants feedback was very good or good (October 2018)
100%
Practical benfits: 100 % of the participants feedback was very good or good (October 2018)

Aims and objectives

Our seminar will provide you with practical tools to help you become more comfortable writing the CTD's CMC documents.
After a short update on grammar, English standards and style, you will be better equipped to write Module 3 and the Quality Overall Summary: you will be able to present data clearly and in compliance with the regulations, and you will be able to sew a "golden thread" through your CMC documents.
In addition, English writing skills will be a part of your repertoire, enabling you to deal with the difficulties posed by the English language to both native and non-native speakers. Having applied your writing skills to practical exercises, you will be able to write the drug substance as well as the drug product sections using sophisticated English.
Last but not least you will learn to cross-check the CMC documents prior to submission and to avoid questions from Health Authorities.
Who should attend
This seminar addresses the needs of those working in the pharmaceutical industry. It will particularly benefit those:
  • writing and reviewing international CMC documents; and
  • wanting to optimise their English writing skills.
Participants should have prior knowledge of the content and structure of Module 3 and the Quality Overall Summary.
Your speakers
Birgit Heilmann
Bayer AG, Leverkusen

Dr. Silvia M. Rogers
MediWrite GmbH, Basel


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

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