Bethesda, Md. – 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 M. Cheung, MSc, Senior Regulatory Coordinator, 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 C. 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 focus on the distinctiveness of each in two concurrent tracks.
The Biosimilars Track will explore management of lifecycle similarities, regulatory and industry perspectives, and maximizing global development. The Vaccines Track will explore 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.