PDA Confirms Five Regulatory Speakers at 2019 Biosimilars and Vaccines…

PDA Confirms Five Regulatory Speakers at 2019 Biosimilars and Vaccines…

The Parenteral Drug Association (PDA) today confirmed five speakers representing global pharmaceutical regulatory agencies at the 2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges, at the Hilton Long Beach, Long Beach, Calif., May 9 – 10, 2019. The confirmed regulatory speakers are:

Anissa Cheung, Consumer Safety Officer, CBER, U.S. FDA

Maria T. Gutierrez Lugo, Supervisory Chemist, CDER, U.S. FDA

Patrick J. Lynch, PhD, Lead Biologist, CDER U.S. FDA

Klara Tiitso, Scientific Administrator, European Medicines Agency

Maria Fernanda R S Thees, Manager of the Office of Biological Products, Agência Nacional de Vigilância Sanitária – ANVISA

This unique conference is really two events in one as it will explore the parallels between the manufacture, supply, and quality considerations of biosimilars and vaccines during the plenary sessions and focuses on the distinctiveness of each in two concurrent tracks.

The Biosimilars Track will explore topics, including management of lifecycle similarities, regulatory and industry perspectives, and maximizing global development. The Vaccines Track will explore topics, including lifecycle management, new technologies, new platforms, and challenges.

The 2019 Biosimilars and Vaccines Conference is the third event offered during PDA’s Biopharmaceuticals Week, which begins May 6 with the two-day 2019 PDA Cell and Gene Therapy Conference. This event includes a regulatory talk by Steven Oh, PhD, Deputy Director, Division of Cellular and Gene Therapies, CBER, FDA.

On May 8, the 2019 PDA Virus Safety Forum takes place with Arifa Khan, Sr. Investigator, Supervisory Microbiologist, CBER, FDA among the speakers.

Press passes are available at https://www.pda.org/about-pda/press-pass-request-form.

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Published at Fri, 19 Apr 2019 00:00:00 +0000