A very warm welcome on behalf of the Scientific Program Planning Committee and PDA. We are pleased to invite you to join us for the 2023 PDA Virus Conference to take place as a face-to-face event on 20-21 June 2023 in Madrid, Spain. This conference will follow a workshop hosted by PDA on "Viral Safety for ATMPs" due to take place on 19 June 2023 at the same venue as the 2023 PDA Virus conference.
This global meeting is organized in close collaboration with an excellent Scientific Program Planning Committee which includes European and U.S. FDA regulators, global industry experts, supplier specialists, and dedicated PDA support.
The overall program is designed to provide an update on regulatory expectations from a truly global perspective with representatives from the EU, the US, and Asia presenting the scientific framework for virus safety of plasma-derived and biotechnology medicinal products, as well as particularly innovative advanced therapy medicinal products. Following on from the recent publication of the draft ICH Q5A R2 document, one of the conference's main themes will be best practices and understanding of the recommendations in this draft document.
Similar to earlier events in this long-standing series, current and newly emerging viral threats, viral safety considerations around the selection of low-risk starting materials, virus detection, and identification methods and strategies, and the design and validation of virus inactivation and removal process will be key topics for discussion. In addition, intensified continuous manufacturing processes and their potential impact on facility design and viral safety will also be considered.
Following the great success of the face-to-face meeting in Brussels in 2022, the 2023 PDA Virus Conference will again provide attendees the opportunity to gather for interactive discussions and continue to invigorate social interactions. This meeting continues to act as a discussion forum that allows for the direct interaction between industry and regulators and will continue to support the wider industry and improve the current understanding and acceptance of new technologies, highlight new and emerging viral risks, and explain novel regulatory approaches.
Panel discussions and ample networking opportunities will complement an impressive scientific program and make it a worthwhile and well-rounded experience for you.
We look forward to meeting you in person in June!
Alison Armstrong, Merck KGaA
Andy Bailey, ViruSure
SCIENTIFIC PROGRAM PLANNING COMMITTEE:
- Alison Armstrong, Merck KGaA
- Andy Bailey, ViruSure
- Johannes Blümel, Paul-Ehrlich-Institut
- Qi Chen, Genentech/Roche
- Tomoko Hongo, Asahi Kasei
- Arifa Khan, U.S. FDA
- Thomas R. Kreil, Takeda
- Sean O’Donnell, Eli Lilly and Company
- Sebastian Teitz, Biopharma Excellence
- Josh Eaton, PDA
- Falk Klar, PDA Europe
- Stefanie Nebelin, Senior Manager Programs & Events, PDA Europe