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Thursday, July 1 • 10:00am - 11:00am
#406 SL: Development of Shared System and Shared REMS: Best Practices and Lessons Learned

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-635-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will focus on best practices and lessons learned for the development and implementation of Shared REMS. These topics will be discussed from the perspectives of the FDA, leaders in industry, and other stakeholders.

Learning Objectives

Identify changes to the REMS statute through the Appropriations Act of 2020; Describe challenges for design and implementation during the development of Shared REMS; Describe processes and challenges for REMS that incorporate >1 product from a single applicant; Discuss best practices for the development of a shared REMS and incorporation of new products into an existing REMS program.

Chair

Jacqueline Sheppard, PharmD

Speaker

FDA Update
Laura Zendel, PharmD

Industry Update
Kevin Holman, MBA, RAC

Industry Update
Kishore Gopu, MBA, MS

Industry Update
Jemma Contreras, PhD


Speakers
avatar for Jemma Contreras

Jemma Contreras

Executive Managing Director, Advisory Group Lead, Syneos Health, United States
Jemma Contreras brings over 15 years of biopharmaceutical consulting to her role as Advisory Group Lead for the Risk and Program Management team at Syneos Health. Over the past decade Jemma has established and grown the Risk and Program Management team, leading the development and... Read More →
avatar for Kevin Holman

Kevin Holman

Head, REMS and Risk Management, Janssen Pharmaceuticals, United States
Kevin Holman, MBA, RAC leads the REMS and Risk Management Center of Excellence at Janssen Pharmaceuticals, where he built and leads a team that oversees the design, implementation, management, and assessment of risk management programs in the U.S. Throughout his career, Kevin has... Read More →
avatar for Kishore Gopu

Kishore Gopu

Director, REMS Operations, Teva Pharmaceuticals, United States
Kishore Gopu, M.S, MBA, is Director, REMS Operations and has been with Teva since 2007 and has served in many departments including Regulatory Affairs, Commercial Operations, Patient Solutions, and Pharmacovigilance. Since joining Teva, Kishore has built REMS department from the ground... Read More →
avatar for Jacqueline Sheppard

Jacqueline Sheppard

Team Leader, OMEPRM, OSE, CDER, FDA, United States
Dr. Jacqueline Sheppard serves as a Team Leader in the Division of Risk Management in the Office of Surveillance and Epidemiology within the FDA’s Center for Drug Evaluation and Research. In this role, she oversees a team of Risk Management Analysts to provide risk management expertise... Read More →
avatar for Laura Zendel

Laura Zendel

Associate Director, FDA, United States
Dr. Laura Zendel is the Associate Director for REMS Design and Evaluation in the Division of Risk Management (DRM) in the Office of Surveillance and Epidemiology within the FDA’s Center for Drug Evaluation and Research. In this role, she serves as a senior level scientist with risk... Read More →

Thursday July 1, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Forum |   09: Regulatory, Forum