Healixia & UPIP-VAPI workshop on GxP compliance
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.
Healixia and UPIP-VAPI organize a workshop on GxP compliance.
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…).
The concept is similar to our very successful seminar in 2022, whereby we discussed different practical cases. The topics we have selected for this year’s sessions are:
Case 1: Pharmacovigilance
Case 2: Complaints
Case 3: GDP – WDA – Import
Case 4: ATMPs
Case 5: Environmental Risk Assessments (ERA)
Click here to find a short summary of the content of the five cases. The cases consist of two parts, with a more generaric part before the coffee break, and with added complexity after the coffee break. In this way both junior and more experience participants can benefit from these sessions. Note that the cases are discussed in parallel and that you will need to select one case to follow. It is however possible to select a different topic before and after the coffee break if you are junior level in one topic and senior level in the other one.
Agenda:
- 09h00 Welcome coffee and registration
- 09h30 Presentation on the interactions between the MAH and its stakeholders
- 10h00 Introduction of the cases and selection of the groups
- 10h15 Case solving in groups -Part 1
- 11h00 Coffee break
- 11h30 Case solving in groups - Part 2
- 12h15 Key learnings from the Case solving discussions
- 12h45 Network lunch
Reading support: