The Science of Submissions Part IA - The principles of the new variation regulation

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About the principles of the new variation regulation, including strategic and operational consideration and the impact on legal roles and responsibilities.

Salud y medicina Empresariales Tecnología

The Science of Submissions - Part IA Principles of the new variation regulation Hans van Bruggen eCTDconsultancy

Agenda ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Principles of new variation regulation Copyright eCTDconsultancy B.V.

Goal ,[object Object],[object Object],[object Object],Principles of new variation regulation Copyright eCTDconsultancy B.V.

New Variation Regulation & Guidance ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Principles of new variation regulation Copyright eCTDconsultancy B.V.

EC 1234/2008 for CP/DCP/MRP ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Principles of new variation regulation Copyright eCTDconsultancy B.V.

EC 1234/2008 for CP/DCP/MRP ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Principles of new variation regulation Copyright eCTDconsultancy B.V.

EC 1234/2008 for CP/DCP/MRP ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Principles of new variation regulation Copyright eCTDconsultancy B.V.

Annex III- example ,[object Object],[object Object],[object Object],Principles of new variation regulation Copyright eCTDconsultancy B.V.

Annex III- example ,[object Object],[object Object],Principles of new variation regulation Copyright eCTDconsultancy B.V.

Guidelines on the operation of the procedures laid down in chapters II, III and IV of the regulation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Principles of new variation regulation Copyright eCTDconsultancy B.V.

Classification Guideline ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Principles of new variation regulation Copyright eCTDconsultancy B.V.

Request classification unforeseen variation (Art. 5) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Copyright eCTDconsultancy B.V. Principles of new variation regulation

Intent for a worksharing procedure to the EMEA ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],20100519 Principles of new variation regulation

Strategic and operational considerations ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],20100519 Principles of new variation regulation

Legal roles and responsibilities ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],20100519 Principles of new variation regulation

Conclusions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],20100519 Principles of new variation regulation

Thank you ! For more info visit www.ectdconsultancy.com or mail to [email_address]

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