Registration of Pharmaceuticals In Europe

Summary

This detailed practical course focuses on the structure and contents of the CTD and eCTD Marketing Authorisation filings, emphasising the latest requirements, with particular emphasis on abridged applications.

• Module 1: The European MA Application Form, SPC, labels and user leaflets etc
• Module 2: Summaries and Overviews
• Module 3: Quality
• Module 4: Nonclinical
• Module 5: Clinical

Who should attend

Over the past 17 years this course has been presented in Europe, the US, Canada and Japan to many hundreds of regulatory affairs staff and ‘dataproviders’ from the pharma companies, contract and consulting companies and from the European national agencies themselves. It has proven invaluable to both relatively new staff and the more experienced professionals wanting to obtain a wider view on requirements as they change jobs or gain in responsibility.

The course is designed for both regulatory affairs staff involved with writing, assembling, compiling, publishing and submitting European files,and the professional staff in the ‘data provider’ groups who design the studies and provide the technical and scientific reports and documentation – the pharmaceutical R&D staff, chemical manufacturing, pharmaceuticalmanufacturing, analytical development, packaging development, QC, clinical trials staff, medical and scientific affairs, medical affairs, and project management.