U.S. FDA, Dutch MEB, and Health Canada Officials to Kick Off PDA’s Biosimilars Workshop Regulators joined on podium with experts from leading pharma companies 16 August, 2018

Bethesda, Md., August 17, 2018 – The Parenteral Drug Association (PDA) is pleased to announce the agenda for the 2018 PDA Biosimilars Workshop, “Getting it Right the First Time for Biosimilar Marketing Applications,” which will be held at the Renaissance Washington DC Downtown Hotel, Sept. 26 – 27.

The workshop features expert presentations from officials from the U.S. FDA, the Netherland’s Medicines Evaluation Board (MEB), and Health Canada during the opening session of the workshop, 2:00 pm – 3:15pm on Sept. 26. The session will explore the challenges encountered with the submission of marketing authorizations for biosimilar products. R. Martijn van der Plas, PhD, Senior Assessor Biologicals will present for MEB and Chantal Depatie, PhD, Biologist Evaluator, will represent Health Canada.

Interactive breakout sessions will follow, and the first day of the workshop will close with a panel discussion with the regulators. Day two of the workshop features additional talks from the regulators and presentations from experts representing companies like Pfizer, CELLTRION, and Novartis

Emanuela Lacana, PhD, Associate Director for Biosimilars and Biologics Policy, at FDA’s Center for Drug Evaluation and Research, will participate in the Day one panel discussion and provide the closing remarks.

The 2018 PDA Biosimilar Workshop immediately follows the PDA/FDA Joint Regulatory Conference, which takes place at the Renaissance Washington, DC Downtown Hotel Sept. 24 – 26. Press passes are available for both events.