PDA Europe Virus Forum 2018
Advanced Technologies for Virus Detection & Clearance in Biological Products
Hilton Florence Metropole, Via del Callavaccio 36, Florence, Italy
This conference was established in 2001 and, held annually since then, alternates between Europe and the U.S. These truly global meetings are organized under the leadership of PDA in close cooperation with European regulatory agencies and the U.S. FDA. They provide an overview and updates on regulatory expectations and scientific investigations related to virus and TSE safety of biotechnology, plasma-derived and cell-derived medicinal products.
As in previous years, virus contamination of raw materials as well as emerging viral threats will be discussed. Appropriate risk mitigation strategies consisting of two elements:
- Testing and processing of raw materials and
- Virus removal/ inactivation capacity of the processes used for production of medicinal products will be taken into consideration.
This PDA Europe Virus Forum reliably provides attendees a unique opportunity for interactive discussion and benchmarking. Exchange of information between industry and regulators will improve the understanding and acceptance of new techniques, highlight new and emerging risks and explain new regulatory approaches.
Dr. Johannes Blümel, Head of Section "Viral Safety", Paul-Ehrlich-Institut