PDA will host a series of workshops to educate and help the industry implement the new Annex 1 revision. PDA has and continues to be committed to developing scientifically sound, practical, technical information, and training programs to advance science and regulation for our members and the industry as a whole.
The intent of the workshops is to highlight specific sections with critical changes and include interactive sessions to provide attendees with clear understanding of and means to implement the requirements of the new Annex 1, in order to address the regulatory expectations. PDA has developed a standardized approach for workshop topics to ensure consistency in the information delivered to the industry.
The workshops will be two days in length, conducted globally (U.S. and EU). They will provide an opportunity for attendees to hear from industry experts and regulators, and open discussions with their peers’ challenges and best practices. While the goal is to conduct these as in-person events to provide the greatest engagement, based on global circumstances where in-person events are not possible, a virtual platform will be used.
SCIENTIFIC PROGRAM PLANNING COMMITTEE:
- Hal Baseman, Valsource, Chair
- Gabriele Gori, GSK, Chair
- Fred Ayers, Eli Lilly and Company
- Amanda Bishop McFarland, Valsource
- Biswarup DasGupta, Sarepta Therapeutics
- Richard Denk, Skan
- Cheryl Essex, Sanofi
- Marc Glogovsky, Valsource
- David Keen, Company for Individuals
- Tracy Moore, MHRA
- Patrick Nieuwenhuizen, PharmaLex
- Don Singer, EcoLab
- Neal Zupec, Baxter