CMC Writing - The essentials - with practical examples and exercises
- Dauer
CMC Writing - The essentials - with practical examples and exercises
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Startdaten und Startorte
Die Startdaten (und ggf. der Startort) für dieses Produkt sind variabel und werden nach der Buchung abgestimmt.
Beschreibung
Die Themen
- Structure and presentation of Module 3 and Module 2 - CTD sections in detail: S-Part, P-Part, specific sections - Country specific requirements, e.g. China, Japan, Brazil, etc. - Considerations for NCEs and generics - Case studies and exercises
Ziele
Our training will provide you with practical tools to help you become more comfortable writing the CTD's CMC documents.
- After an introduction on the general structure and presentation of CMC documents in Module 3 and Module 2, our experts will dive deeper into different relevant CTD sections sharing practical examples and their experiences with you.
- You will learn about the specific requirements for NCEs and generics. Further…
Frequently asked questions
Es wurden noch keine FAQ hinterlegt. Falls Sie Fragen haben oder Unterstützung benötigen, kontaktieren Sie unseren Kundenservice. Wir helfen gerne weiter!
Die Themen
- Structure and presentation of Module 3 and Module 2 - CTD sections in detail: S-Part, P-Part, specific sections - Country specific requirements, e.g. China, Japan, Brazil, etc. - Considerations for NCEs and generics - Case studies and exercises
Ziele
Our training will provide you with practical tools to help you
become more comfortable writing the CTD's CMC documents.
- After an introduction on the general structure and presentation
of CMC documents in Module 3 and Module 2, our experts will dive
deeper into different relevant CTD sections sharing practical
examples and their experiences with you.
- You will learn about the specific requirements for NCEs and
generics. Furthermore our experts will address details on country
specific CMC documents.
- After attending the seminar 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.
Wer sollte teilnehmen?
This training will particularly benefit those writing and
reviewing international CMC documents. It addresses the needs of
those who are new in the field or desire to refresh their
knowledge.
- Participants should have prior knowledge of the content and
structure of Module 3 and the Quality Overall Summary.
- The focus is on NCEs and generics.
Schreiben Sie eine Bewertung
Haben Sie Erfahrung mit diesem Seminar? Schreiben Sie jetzt eine Bewertung und helfen Sie Anderen dabei die richtige Weiterbildung zu wählen. Als Dankeschön spenden wir € 1,00 an Stiftung Edukans.Es wurden noch keine FAQ hinterlegt. Falls Sie Fragen haben oder Unterstützung benötigen, kontaktieren Sie unseren Kundenservice. Wir helfen gerne weiter!