2018-03-23 12:50:27 UTC

Overview of the Regulatory Framework and FDA’s Guidance for the Development and Approval of Biosimilar and Interchangeable Products in the US

Duration

.75

About

In this on-demand webinar, Sue Lim, MD, director of the Scientific Review staff with the Therapeutic Biologics and Biosimilars staff at FDA, provides an overview of the background, terminology and general requirements for biosimilar and interchangeable product applications. This activity is a collaboration of the AGA Institute and the Crohn's and Colitis Foundation.

This program is supported by independent educational grants from Boehringer Ingelheim Pharmaceuticals, Inc. and Pfizer.

Who Should Take this Course


This activity is intended for gastroenterologists, GI fellows, nurse practitioners, physician assistants and other health care professionals who treat GI disorders.

Learning Objectives


At the conclusion of this presentation, learners will:

  • Define the differences between biosimilarity (substitution for originator biologic) vs. interchangeability (potential for multiple switches).
  • Explain how the FDA allows sponsors of biosimilars to rely on data extrapolation instead of traditional clinical trials. 

Activity

 

Claim CME

CME/Maintenance of Certification (MOC) Information


The AGA Institute is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

The AGA Institute designates this enduring activity for a maximum of .75 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

In accordance with the ACCME’s Standards for Commercial Support of Continuing Medical Education, all faculty and planning partners must disclose any financial relationship(s) or other relationship(s) held within the past 12 months. The AGA Institute implements a mechanism to identify and resolve all conflicts of interest prior to delivering the educational activity to learners.

Successful completion of this CME activity enables the participant to earn up to .75 MOC points in the American Board of Internal Medicine’s (ABIM) MOC program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC points.

CME/MOC expiration date: April 3, 2019

If you have any questions, please email education@gastro.org

Faculty Relationship and Financial Disclosures

View financial disclosures for presenters, planning committee and staff

Planning Committee

Gary R. Lichtenstein, MD, AGAF, University of Pennsylvania

AGA Staff

Maura H. Davis

Monique S. Dyson, MS, CHES

Alison Kim, PhD

Crohn’s & Colitis Foundation Staff

Orna Ehrlich

Laura Wingate

Who Should Take this Course

This activity is intended for gastroenterologists, GI fellows, nurse practitioners, physician assistants and other health care professionals who treat GI disorders.

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