Скачать с ютуб EU Variation Overview Regulatory Lectures by Rajashri Ojha at Raaj Pharmaelearning в хорошем качестве

EU Variation Overview Regulatory Lectures by Rajashri Ojha at Raaj Pharmaelearning

Brief recap on registration of Pharmaceutical Products in Europe Introduction of Product Life Cycle Management of Pharmaceutical Products in Europe EU Variation Applications Concept of “Variation” to the terms of Marketing Authorization Variation classification guideline for European Union Types of Variations Definitions each type of variation, fundamental concept & examples Documentation required for variation filling Grouping of variations Timelines of variations EU Renewal Applications Concept of “Renewal “ to the terms of Marketing Authorisation Renewal submission timelines Documentation required for Renewal filling Takeaway message to people working for Product Life Cycle Management of Pharmaceutical Products