CTD: requirements for non-clinical/clinical modules and eCTD-readiness - Focus on small molecules and biologics

- Non-clinical modules in the CTD: Challenges with modules 2.4, 2.6 and 4 - Clinical modules in the CTD: Challenges with modules 2.5, 2.7 and 5 - Workshop/working on realistic example scenarios - Specific requirements for a bibliographic application - eCTD-readinessNon-clinical/clinical content in the dossier: Are you a beginner in the field and would like to feel confident working competently on modules 2, 4 and 5 in the future? Are you already an experienced specialist and would like to refresh, professionalise or structure your knowledge? Then youve come to the right place!LernzieleThis online seminar will provide you with an overview of the relevant non-clinical and clinical data for preparing the authorisation application dossier.You will discuss these questions with the experts, among others:- - Which data, graphs and tables must find their way into the CTD dossier? - What are the requirements for the study reports? - What are the regulatory requirements for the Clinical Expert Report? - Dealing with literature data/well-established use applications- After attending the seminar, you will be able to work competently on modules 2, 4 and 5.ZielgruppenThis online seminar is aimed at employees in pharmaceutical drug development who create, process or integrate/write non-clinical/clinical data into the marketing authorisation application dossier or people who will take on these tasks in the future.In particular, employees in the drug authorisation, clinical research, R&D and medical science departments will benefit from the seminar.- Specialists from the phytopharmaceutical industry are also very welcome however, in general the focus will be on small molecules and biologics.