CMC Documents: Scientific writing for regulatory submission
Seminar
Online
Beschreibung
-
Kursart
Seminar
-
Methodik
Online
You would like to feel more secure writing CMC documents? Our online training will provide you with practical tools and enable you to deal with the difficulties posed by the English language to both native and non-native speakers. After attending this virtual seminar you will be able to present data clearly and in compliance with the regulations.
Meinungen
Erfolge dieses Bildungszentrums
Sämtlich Kurse sind auf dem neuesten Stand
Die Durchschnittsbewertung liegt über 3,7
Mehr als 50 Meinungen in den letzten 12 Monaten
Dieses Bildungszentrum ist seit 16 Mitglied auf Emagister
Themen
- Speakers
Inhalte
Detailed programme
09:00 - 17:00 seminar
You may dial in 30 min. before the session
09:00
Birgit Heilmann
Structure and presentation of Module 3 and the Quality Overall Summary
- 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
10:15
Dr Silvia Rogers
English writing skills for Module 3 and the Quality Overall Summary
- Key elements of good CMC writing Punctuation 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, redundancies Writing ethics
12:30 Lunch break
13:45
Dr Silvia Rogers
Language pitfalls to be avoided in CMC modules
- For native English speakers
- For non-native English speakers
14:30 Coffee break
14:45
Dr Silvia Rogers
Putting what we have learned into practice
- Studies and exercises
16:00
Birgit Heilmann
Consistent CMC documents and cross-checks
- 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
Detailed programme
09:00 - 17:00 seminar
You may dial in 30 min. before the session
09:00
Birgit Heilmann
Structure and presentation of Module 3 and the Quality Overall Summary
- 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
10:15
Dr Silvia Rogers
English writing skills for Module 3 and the Quality Overall Summary
- Key elements of good CMC writing Punctuation 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, redundancies Writing ethics
12:30 Lunch break
13:45
Dr Silvia Rogers
Language pitfalls to be avoided in CMC modules
- For native English speakers
- For non-native English speakers
14:30 Coffee break
14:45
Dr Silvia Rogers
Putting what we have learned into practice
- Studies and exercises
16:00
Birgit Heilmann
Consistent CMC documents and cross-checks
- 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
Detailed programme
Detailed programme
09:00 - 17:00 seminar
You may dial in 30 min. before the session
09:00 - 17:00 seminar
You may dial in 30 min. before the session
09:00
Birgit Heilmann
Structure and presentation of Module 3 and the Quality Overall Summary
- ...
CMC Documents: Scientific writing for regulatory submission