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Wednesday, June 17 • 2:00pm - 3:00pm
#334 L: Best Practices for Virtual Meetings with FDA!

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-706-L04-P; CME 1.00; IACET 1.00; RN 1.00

Meetings with FDA during development are key to inform product strategies and increase probability of success. Given the recent COVID-19 pandemic, everyone has adjusted to a new 'norm' - virtual meetings. Hear from FDA and industry experts on best practices for holding a virtual meetings.

Learning Objectives

Identify the best practices for virtual PDUFA meetings; Describe how to change the way you prepare for virtual meetings.

Chair

Khyati Roberts, RPh

Speaker

Best Practices for Virtual Meetings: Industry Perspective
Todd Paporello, PharmD, MBA

FDA Update and Best Practices for Virtual Meetings
Khushboo Sharma, MBA

Best Practices for Meeting Requests and Briefing Packages
Lisa Yanoff, MD



Speakers
avatar for Khyati Roberts

Khyati Roberts

Head US/Canada, Regulatory Policy and Intelligence, AbbVie, Inc.
Khyati leads regulatory policy advocacy efforts for the U.S. and Canada and coordiantes international harmonization efforts. She joined AbbVie in 2012 and has nearly 30 years of regulatory experience. Khyati has also provided regulatory advice to the biopharmaceutical industry on... Read More →
avatar for Todd Paporello

Todd Paporello

Vice President and Head of Regulatory Affairs Americas, Bayer
Todd Paporello is Vice President and Head of Regulatory Affairs Americas at Bayer Pharmaceuticals. Before joining Bayer, he held leadership positions of increasing responsibility within regulatory affairs at Roche, Genentech, Merck, and Schering-Plough. Todd holds pharmacy (PharmD... Read More →
avatar for Khushboo Sharma

Khushboo Sharma

Deputy Director for Operations, Office of New Drugs, CDER, FDA
Khushboo Sharma is the OND Deputy Director for Operations in CDER's Office of New Drugs. In this role, Khushboo has oversight of business processes and staff providing key support for regulatory review and oversight of resource capacity planning including staffing for OND. Khushboo... Read More →
LY

Lisa Yanoff

Division Director, OND, CDER, FDA
Dr. Lisa Yanoff trained in Diabetes, Endocrinology, and Metabolism at the National Institutes of Health and joined FDA in 2008 in the Division of Metabolism and Endocrinology Products in CDER's Office of New Drugs (OND). She is currently the acting director of the Division of Diabetes... Read More →


Wednesday June 17, 2020 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session