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CMC Biopharma MasterClass

21 March - 22 March

This MasterClass will provide a deep and detailed instruction on Chemistry, Manufacturing and Controls (CMC) requirements and review processes for clinical trial, registration and postapproval drug applications. Attendees will also have a solid but comprehensive overview of all relevant regulatory, technical and quality elements, implementation and documentation of the required CMC analytical and stability knowledge…

CMC Biopharma MasterClass 3.0

07 May - 08 May

This MasterClass will provide a deep and detailed instruction on Chemistry, Manufacturing and Controls (CMC) requirements and review processes for clinical trial, registration and postapproval drug applications. Attendees will also have a solid but comprehensive overview of all relevant regulatory, technical and quality elements, implementation and documentation of the required CMC analytical and stability knowledge…

Risk & Pharmacovigilance MasterClass

03 June - 04 June

Training Introduction The focus of this two days training will be on providing an update of ongoing activities regarding medicines’ risk and signal management. The first day will be an opportunity to provide the participants practical advice on RMP drafting and preparation as well the accessors point of view in evaluating an RMP. Moreover, the…

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