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Tuesday, June 18 • 8:00am - 9:00am
#209: Leveraging New Meeting Opportunities in PDUFA VII: Experiences with Type D and INTERACT

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-564-L04-P; CME 1.00; RN 1.00

This forum will address experience to date with new meeting types included in PDUFA VII, including Type D and INTERACT. Forum participants will evaluate successes, opportunities for improvement, and discuss how learnings can be shared.

Learning Objectives

Evaluate experiences to date with Type D and INTERACT meetings included in PDUFA VII; Identify opportunities to improve implementation of new meeting types to promote innovation and optimize FDA-Sponsor Interactions.

Chair

Victoria A. Dohnal, RAC

Speaker

Industry Update
Victoria A. Dohnal, RAC

FDA Update
Christy L. Cottrell

FDA Update
Adriane Fisher, MBA, MPH

Industry Update
Alex May, MS


Speakers
avatar for Christy Cottrell

Christy Cottrell

Chief, Project Management Staff,, ORO, DROOD, CDER, FDA, United States
Christy Cottrell is a Chief Project Manager in the FDA's Office of New Drugs, Division of Regulatory Operations for Oncologic Diseases. She co-leads a team of Regulatory Project Managers who support the Division of Oncology 1 which handles the review of drugs and biologics for reproductive... Read More →
avatar for Victoria Dohnal

Victoria Dohnal

Director, Global Regulatory Policy and Intelligence, Johnson & Johnson Innovative Medicine, United States
Victoria Dohnal is currently Director, Global Regulatory Policy and Intelligence at Johnson and Johnson (J&J) where she is responsible for driving US regulatory intelligence and policy work related to rare diseases, patient focused drug development, cell and gene therapies, and PDUFA... Read More →
AF

Adriane Fisher

Regulatory Project Manager, OTP, CBER, FDA, United States
Adriane Fisher joined the FDA as a Regulatory Project Manager in September 2018, where she has provided review management throughout the product life cycle, from pre-submission meetings to post-marketing submissions. As an RPM, Adriane also acts as the liaison between FDA and industry... Read More →
AM

Alex May

North America Lead - Regulatory Science, Policy, & Intelligence, District of Columbia, United States
Alex May leads regulatory policy, science, & intelligence for North America and global regulatory policy efforts on plasma at CSL Behring. He serves as co-chair on BIO's Meetings Task Force and NORD's Regulatory Affairs Working Group. Previously, Alex was a Director of Science & Regulatory... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum