During this session, we will tackle the required departmental (inter)actions for ensuring full GxP compliance. The Marketing Authorization Holder’s responsibilities will be highlighted within the legal framework of the different good practice guidelines (GMP, GDP, GVP…).

In collaboration with UPIP-VAPI. If you are a member at UPIP-VAPI but not at Healixia, you can register here.

PROGRAM:

• 13u30 - Welcome coffee and registration
• 14u00 - Regulation and interaction between stakeholders
• 14u30 - 2022 update: Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders
• 15u00 - Introduction of the cases
• 15u30 - Coffee break
• 15u50 - Case solving in groups
• 16u50 - Case presentation and discussion
• 17u30 - Closing drink