This session is the second part of a two-part training course on the “Sources of life sciences regulation”. It serves to provide participants with a high-level overview of the rules and regulations applicable to medicinal products for human use in the European Union. The session will include a specific part on the Belgian legislation. It will also provide the audience with practical tips on researching applicable laws.

During this webinar, we will focus on how to use the Investigator's Brochure to de-risk a First-in-Human (FIH) trial.  Speakers: Prof. Dr. Jan de Hoon and Dr. Thomas Lodeweyckx (UZ Leuven)

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.

This first session on the “Sources of life sciences regulation” is intended to provide an overview of the main body of the legislation applicable to the placing on the market or making available of medical devices in the European Union. The session will include a specific part on the Belgian legislation. It will also provide the audience with practical tips on researching applicable laws.

The how, the why and the who: all you would like to know about the RIP (Responsible for Information and Publicity) when working outside regulatory affairs. This webinar is aimed at life science professionals who are not necessarily familiar with the term or who would like to learn more on it. Healixia Essentials: during several short sessions throughout the year, we tackle different terms, concepts or processes to keep all professionals up to speed with the essentials of the life sciences industry.

On behalf of the EUFEMED Board, you are kindly invited to the EUFEMED General Assembly 2022. It will be a virtual event; you will receive the dial-in information shortly. As EUFEMED needs to register the attendees, we kindly ask you to confirm your presence by registering, if you are planning to attend (Healixia members only - login first to register).