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Monday, June 24 • 2:15pm - 3:15pm
#146: Communications with Regulators Beyond Formal Meetings

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-546-L04-P; CME 1.00; IACET 1.00; RN 1.00

FDA and industry experts share best practices when seeking advice via Critical Path Innovation Meetings (CPIM), parallel scientific advice, and the Initial Targeted Engagement for Regulatory Advice on CBER products (INTERACT).

Learning Objectives

Identify when you should seek advice beyond formal meetings with FDA; Discuss best practices in obtaining parallel scientific advice from FDA and EMA; Discuss best practices in obtaining advice via a Critical Path Innovation Meeting (CPIM); and, discuss the impact to regulatory strategies and timelines.

Chair

Khyati Roberts, PharmD, RPh

Speaker

Overview of FDA-EMA Parallel Scientific Advice
Sandra L. Kweder

Seeking Advice from EMA
Tânia Teixeira, PharmD

Overview of Critical Path Innovation Meetings
Chekesha Clingman, PhD, MBA

Industry Perspective on Communications Beyond Formal Meetings
Nicole Mahoney, PhD

Overview of INTERACT Meetings
Christopher Joneckis, PhD



Speakers
avatar for Chekesha Clingman

Chekesha Clingman

Associate Director for Strategic Partnerships, OTS, CDER, FDA
Dr. Chekesha Clingman is a Commander in the US Public Health Service and the Associate Director for Strategic Partnerships in the Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA). Dr. Clingman manages the... Read More →
CJ

Christopher Joneckis

Associate Director for Review Management, CBER, FDA
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avatar for Sandra Kweder

Sandra Kweder

Deputy Director, Liaison to the EMA, Office of International Programs, OC, FDA
Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA Office of International Programs. Dr. Kweder previously served for more than a decade as Deputy Director, Office of New Drugs, in FDA’s Center for Drug Evaluation & Research, where she actively led numerous... Read More →
avatar for Nicole Mahoney

Nicole Mahoney

Senior Director, Regulatory Policy, Flatiron Health
Nicole Mahoney is the Senior Director of Regulatory Policy at Flatiron Health, helping advance the use of real world evidence for regulatory decision making. Prior to her current role, she was a Director of Global Regulatory Policy at Merck, advocating for incentives to spur antibiotic... Read More →
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 over 25 years of regulatory experience. Khyati has also provided regulatory advice to the biopharmaceutical industry on product... Read More →
avatar for Tânia Teixeira

Tânia Teixeira

EMA Liaison Official at FDA, European Medicines Agency (EMA)
Tania Teixeira is the EMA Liaison Official to FDA. She started her career in the pharmaceutical industry and joined EMA in 2004. She held positions as a Head of service for Referrals, dealing with emerging concerns which require a harmonised position across the EU, and as Product... Read More →


Monday June 24, 2019 2:15pm - 3:15pm
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session