CMC Documents: Scientific Writing for Regulatory Submission
Update your CMC English writing skills - with many practical exercises!
- 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
Aims and objectivesOur 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.
- writing and reviewing international CMC documents; and
- wanting to optimise their English writing skills.
- CMC writing: individual freedom of writing vs mandatory and formal requirements
- Generation and presentation of data
- Roles and responsibilities
- "Good Document Practice"
- Use of GMP documents for submission
10:00 Coffee break
- Key elements of good CMC writing
- Word order (syntax) and subject-verb agreement
- Correct use of verb tenses
- Active versus passive writing
- Abbreviations and acronyms
- Using capital letters
- Consistent spelling (American versus British)
- Expressing numbers
- Best practice
- Avoiding common misconceptions, jargon and redundancies
- Writing ethics
- For native English speakers
- For non-native English speakers
14:30 Coffee break
- Studies and exercises
- Consistent and compliant CMC documents
- Cross-checking Module 3: essentials and fine-tuning within and across CMC documents
- Avoiding questions from Health Authorities
- Do's and don'ts
- Examples of critical sections
17:00 End of seminar
Head of Product Documentation Pharmaceuticals Division - Quality
Nähere Informationen finden Sie hier.
Pharmacologist; Extensive R&D experience as a project manager. Today owner of MediWrite, Medical and Scientific Writing in Basel, and lecturer at the University of Basel. Before forming MediWrite in 1994, Dr Silvia Rogers gained extensive experience in pharmaceutical research, including project management in a major pharmaceutical company. She lectures on medical writing at Basel University and has provided extensive training in various aspects of medical and scientific writing and presentation. She has written many expert reports, regulatory documents, scientific publications as well as study reports and is author of two text books on medical and scientific writing.
Nähere Informationen finden Sie hier.
Phone: +49 221 8 80 42-0
Fax: +49 221 8 80 42-44 44
Dieses Seminar kann als Wahlmodul im Rahmen unseres Qualifikationslehrgangs zum CMC-Specialist in Regulatory Affairs belegt werden. Das Lehrgangskonzept: - Sie besuchen unseren Basiskurs "Der CMC-Manager in Regulatory Affairs" - Danach nehmen Sie an 3 weiteren Seminar-Modulen (= 3 Seminartagen) teil, die Sie sich individuell aus dem Lehrgangscurriculum zusammenstellen - Sie erhalten eine strukturierte Weiterbildung und umfassendes Wissen in CMC Regulatory Affairs - Sie können sich durch die gezielte Seminarauswahl gemäß Ihres Tätigkeitsschwerpunktes spezialisieren
Practical advices for our daily work; I had a list of questions and they all have been answered
The seminar gave a very good review on the consistancy check + proofreading of CMC documents as well as an perfect and detaild description on scientific writing!
Very updated and applicable to CMC job
It was very usefull for improving the technical writing skills as well as details about the need content and controls in the M3 module.
Very good organization.
It is a very useful seminar for Module 3.
Very useful with practical examples.
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