Two FDA speakers at ECA Continuous Manufacturing Conference

Recommendation
13/14 May 2025
GM Requirements for Planning, Qualification and Operation
The FDA has confirmed the participation of a second speaker at the ECA Continuous Manufacturing Conference. This shows how important this topic and advanced manufacturing in general is to the FDA. By advanced manufacturing, the FDA means innovative pharmaceutical manufacturing technologies with the potential to improve the reliability and robustness of manufacturing processes. To this end, the FDA has launched the Advanced Manufacturing Technologies Programme.
In addition to Dr Sau Lee (Deputy Director of Science, Office of Pharmaceutical Quality, CDER), the participation of Dr Rapti Madurawe has now been confirmed. Dr Madurawe is Division Director in the Office of Process and Facilities and the FDA topic lead for the ICH Guidance Q13 on Continuous Manufacturing.
The conference will take place from 16 to 18 April in Lisbon/Cascais. The conference will include a full day visit to Hovione's continuous manufacturing areas and laboratories. Further information can be found in the conference programme.