Bethesda, Md. – The Parenteral Drug Association (PDA) today announced that it has confirmed Douglas Throckmorton, MD, Deputy Director for Regulatory Programs, Center for Drug Evaluation and Research (CDER), U.S. FDA, as an opening plenary speaker of the 2020 PDA/FDA Joint Regulatory Conference, which will be held virtually Sept. 14 – 16.
The theme of the 2020 conference is “The Future Is Now: Effective Quality Management and Robust Manufacturing.” Speakers from the U.S. FDA, other regulatory bodies, and industry will explore the continuing evolution of innovative manufacturing capabilities and the potential effect on quality, compliance, and regulatory lifecycle paradigms.
FDA senior officials will discuss Center-specific initiatives as well as provide compliance updates in what has become one of the most popular recurring sessions of the event.
PDA and the U.S. FDA once again are co-sponsoring the PDA/FDA Joint Regulatory Conference, which is now in its 29th year. Because of the ongoing challenges of the COVID-19 pandemic, the U.S. FDA and PDA agreed to hold the event virtually.
This flagship conference consistently provides a unique opportunity to hear from and engage with numerous regulatory and industry leaders concerning the latest manufacturing, quality, supply, and related compliance issues in an ever-evolving landscape.
Tia Bush, Senior Vice President, Quality, Amgen, Inc., is a confirmed speaker for the closing plenary session. PDA had confirmed other industry expert speakers from GlaxoSmithKline PLC, AstraZeneca PLC, Merck Sharpe & Dohme Corp., Eli Lilly and Company, and Sanofi Pasteur.
Among the many topics these and other industry and regulatory authority experts will address are:
- Commercialization challenges in cell and gene therapy
- Data analytics in manufacturing
- De-risking your supply chain
- Quality assurance role in 2020 and beyond
- OOS investigations
- U.S. FDA Emerging Technology program
For more information, visit the 2020 PDA/FDA Joint Regulatory Conference website: https://www.pda.org/global-event-calendar/event-detail/2020-pda-fda-joint-regulatory-conference
Members of the press may request a press pass at the following website: https://www.pda.org/about-pda/press-pass-request-form.