CMC Writing - The essentials - with practical examples and exercises

- 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 exercisesYou as beginner or refresher would like to feel more secure writing CMC documents? Our experts will provide you with practical tips and tricks and share their experiences with you. After attending this virtual seminar you will be able to present data clearly and in compliance with the regulations.LernzieleOur training will provide you with practical tools to help you become more comfortable writing the CTDs 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.ZielgruppenThis 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.