GAPP Work Package 5 – Multi Country Workshop

Background:
Work Package (WP) 5 of the GAPP Joint Action (JA) will develop guidance on how a preparation process
authorisation (PPA) system should or could be organised. The purpose of this Multi Country Workshop to
promote discussion to consider and gather information on the status of Preparation Process
Authorisation (PPA) systems, the associated legislative requirements, guidance and procedures in place
across MS CA’s in the field of tissues and cells and Assisted Reproductive Technology (ART).

Agenda:

14:00 – 14:15: Welcome address – Stefaan Van Der Spiegel (DG SANTE);
14:15 – 14:45: Overview of WP5 and Objectives of Multi Country Workshop (WP 5 Leaders);
14:45 – 17:00: Multi Country Workshop; (at 4 o’clock there will be a fifteen-minute break)
a) Framework for Competent Authority;
b) Application Process;
c) Risk Assessment;
d) Review and Evaluation;
e) Authorisation;

17:00 – 17:30: Discussion, Questions and Answers;

17:30 – 17:45: Closing Remarks – Stefaan Van Der Spiegel (DG SANTE)