Presentations from the discussion event on topical GDP, GMP and ATMP issues on 13 February 2023

On 13 February 2023, Fimea held a virtual discussion event on topical issues concerning Good Distribution Practices (GDP), Good Manufacturing Practices (GMP) and Advanced Therapy Medicinal Products (ATMP).

Event programme and presentations:

Opening of the event and Fimea's news (pdf) (in Finnish)
Eeva Leinonen, Head of Unit

GMP news (pdf) (in Finnish)
Mervi Saukkosaari, Head of Division

GDP news (pdf) (in Finnish)
Minna Kurronen, Senior Inspector

Update of the OMS and EU GMP Annex 11: Computerised Systems guide (pdf) (in Finnish)
Mirka Laavola, Senior Officer

Latest on the availability of medicines and the regulation on EMA’s extended mandate (pdf) (in Finnish)
Julia Lehtinen, Senior Inspector

EU GMP Annex 1: Manufacture of Sterile Medicinal Products (pdf)
Pirjo Hänninen, Senior Inspector

ATMP news (pdf) (in Finnish)
Pirjo Hänninen, Senior Officer