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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, United States
Khyati Roberts leads regulatory policy advocacy efforts for U.S. and Canada and co-leads the day-to-day operations of the global regulatory policy and intelligence team at AbbVie. She has over 30 years of regulatory experience including nearly 14 years at the U.S. FDA/Center for Drug... Read More →
avatar for Todd Paporello

Todd Paporello

Vice President, Global Head of Regulatory Affairs, Specialty Care, Sanofi, United States
Todd Paporello is the Vice President & Global Head of Regulatory Affairs Specialty Care at Sanofi. Before joining Sanofi, he held leadership positions of increasing responsibility within regulatory affairs at Bayer, Roche, Genentech, Merck, and Schering-Plough. Todd holds pharmacy... 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