This one-hour webinar will provide an overview of the FDA drug development process as well as the value of Patient-Focused Drug Development (PFDD) meetings. We hope this webinar will spike your interest in being part of this important virtual meeting for the hearing loss community taking place on Tuesday, May 25, 2021.
Date: April 8, 2021
Time: 2 p.m. ET, 1 p.m. CT, Noon MT, 11 a.m. PT
Larry Bauer is a senior regulatory drug expert with Hyman, Phelps, & McNamara, P.C. and assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Prior to this position he worked at the FDA in CDER’s Rare Diseases Program working on policy, education, and science related to rare disease drug development and 17 years at the National Institutes of Health. He has expertise in rare pediatric disease priority review vouchers and designations, expedited programs, and patient engagement including extensive experience guiding patient advocacy groups. He also has served on the National Organization for Rare Disorders (NORD) Advocacy Committee.
James E. Valentine is an associate attorney with Hyman, Phelps & McNamara, P.C., where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. He also works with clients on clinical trials operations and compliance matters. As an adjunct professor at the University of Maryland School of Law, he teaches a course in food and drug law. Prior to joining the firm in 2014, he worked for the U.S. Food and Drug Administration (FDA) Office of the Commissioner where he facilitated patient input in benefit-risk decision-making and served as a liaison to stakeholders on a wide range of regulatory policy issues.
Helpful Hints and Tutorials
- Registration is required for this event. After registering, you will receive a confirmation email containing information about joining the meeting.
- Use a computer. If possible, attend the meeting on a computer rather than via a smartphone or iPad. This will give you the best layout to view the captions as well as other meeting features.
- Captions. HLAA webinars are open or closed captioned. Subtitles will be visible at the bottom of the meeting Zoom screen.
- Check your time zone. This meeting will take place live at 2 p.m. ET, 1 p.m. CT, Noon MT and 11 a.m. PT. You should make note of your time zone so you do not miss the meeting.
NOTE: HLAA does not offer Continuing Education Units (CEUs) for participation in our webinars.
Questions? Feel free to email us at firstname.lastname@example.org.