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PDA Announces Regulatory Speakers at Revision of Annex 1 Workshop in Berlin

For Immediate Release:
05/04/2017
Media Inquiries:
Walt Morris
/ morris@pda.org /
301-656-5900, x. 148

Bethesda, Md., May 3, 2017 – The Parenteral Drug Association (PDA) today released the names of confirmed health authority speakers at its 2017 Revision of Annex 1 Workshop, at the Hilton Berlin, June 12, 2017, which precedes the 2nd PDA Europe Annual Meeting: Global Healthcare of the Present & Future, June 13-14.

Andrew Hopkins, representing the UK Medicines and Healthcare products Regulatory Agency (MHRA), and Beate Reutter, representing the German Agency (Landesamt für Soziale Dienste), will discuss the current status of the EMA effort to revise EU GMP Annex 1: Manufacture of Sterile Medicinal Products.

The Workshop will also look at how Annex 1 fits into the current regulatory framework of other guidelines, such as ICH Q9 and Q10 and how the changes will potentially impact the industry.

A PDA task force has been preparing to comment on the revised Annex 1 when the draft is released for public comment later this year. Gabriele Gori, GlaxoSmithKline Vaccines and a PDA task force leader, will be on hand at the workshop and will summarize the workshop results.

The PDA task force published two points to consider documents on aseptic processing in 2015 and 2016 to help establish current industry best practices in this complicated manufacturing area.