PDA Letter Article

You’re Invited to the 2023 PDA Virus Conference

by Alison Armstrong, Merck KGaA, and Andy Bailey, ViruSure

On behalf of the Scientific Program Planning Committee and PDA, we are pleased to invite you to a face-to-face event at the 2023 PDA Virus Conference on June 20-21 in Madrid, Spain. This conference will follow a workshop hosted by PDA on Viral Safety for ATMPs on June 19, 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, including European and U.S. FDA regulators, global industry experts, supplier specialists and dedicated PDA support.

The program is designed to provide an update on regulatory expectations from a global perspective, with representatives from the European Union, the United States and Asia presenting the scientific framework for virus safety of plasma-derived and biotechnology medicinal products, as well as innovative advanced therapy medicinal products. Following 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, such as 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, intense manufacturing processes and their potential impact on facility design and viral safety will also be considered.

After 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 direct interaction between industry and regulators and will steadily support the industry overall 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! 

About the Authors

Alison Armstrong Alison Armstrong, PhD, started her career in academic research with a strong interest in the role of viruses in various pathogenic conditions. Moving to the contract testing sector in the late 1990s, Alison led many teams in different divisions within Merck and currently holds the position of Global Head of Technical and Scientific Solutions. During her career, Alison has authored many articles on trends in biosafety testing and is a member of industry forums on virology methods and alternate and rapid technologies.

Andy Bailey Andy Bailey is a protein chemist and experienced virologist and served for nine years at the MRC Virology Unit in Glasgow. In 1995, he moved to the industry sector, initially as Director of Virus Validation services with Q-One Biotech Ltd, then as manager at the Global Pathogen Safety group of Baxter Healthcare in Vienna, Austria. He has been the CEO of ViruSure for the last 17 years and is now a part of the Asahi Kasei Medical group. Over the last 27 years, Andy has been actively involved in the virus and prion safety field, presenting at numerous regulatory agencies for either support of products or as an invited speaker at expert workshops.