CME/CE Information

LEARNING OBJECTIVE

Upon completion of the activity, participants should be able to:

• Summarize key aspects of the FDA licensure of biosimilar products, including the main types of data evaluated and the basis for extrapolation of data

ACTIVITY FACULTY

Sanjiv S. Agarwala, MD
Chief, Oncology & Hematology
St. Luke’s University Health Network
Professor of Medicine
Temple University
Philadelphia, Pennsylvania

METHOD OF PARTICIPATION / HOW TO RECEIVE CREDIT

1. There are no fees for participating in and receiving credit for this activity.
2. Review the activity objectives and CME information.
3. Complete the CME activity.
4. Complete the posttest. A score of at least 75% is required to successfully complete this activity. The participant may take the test until successfully passed.
5. Complete the CME evaluation/attestation form, which provides each participant with the opportunity to comment on how participating in the activity will affect their professional practice, the perception of commercial bias, and whether or not the objectives were met.
6. Credit documentation/reporting:
   1. If you are requesting AMA PRA Category 1 Credits™ or a certificate of participation—your CME certificate will be available for download.

CLICK HERE TO VIEW TECHNICAL REQUIREMENTS

ACCREDITED PROVIDER

This activity is provided by The France Foundation.

TARGET AUDIENCE

This activity is intended for physicians and allied health clinicians who treat patients with gastrointestinal inflammation.

STATEMENT OF NEED

Many gastroenterologists are lacking knowledge regarding what exactly biosimilars are, how they are formulated, and differences and similarities with generic and originator biologic agents.

ACCREDITATION STATEMENT

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

CREDIT DESIGNATION

Physicians
The France Foundation designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

RESOLUTION OF CONFLICTS OF INTEREST

In accordance with the ACCME Standards for Commercial Support of CME, The France Foundation implemented mechanisms, prior to the planning and implementation of this CME activity, to identify and resolve conflicts of interest for all individuals in a position to control content of this CME activity.

DISCLOSURES

IIt is the policy of The France Foundation to ensure balance, independence, objectivity, and scientific rigor in all its sponsored educational activities. All faculty, activity planners, content reviewers, and staff participating in this activity have disclosed to the participants any significant financial interest or other relationship with manufacturer(s) of any commercial product(s)/device(s) and/or provider(s) of commercial services. The intent of this disclosure is not to prevent a person with a relevant financial or other relationship from participating in the activity, but rather to provide participants with information on which they can base their own judgments. The France Foundation has identified and resolved any and all conflicts of interest prior to the release of this activity.

Activity Staff Disclosures

The planners, reviewers, editors, staff, CME committee, or other members at The France Foundation who control content have no relevant financial relationships to disclose.

Faculty Disclosures

Sanjiv S. Agarwala, MD, has no relevant financial relationships to disclose.

UNAPPROVED USE DISCLOSURE

The France Foundation requires CME faculty (speakers) to disclose to the attendees when products or procedures being discussed are off-label, unlabeled, experimental, and/or investigational (not FDA approved); and any limitations on the information that is presented, such as data that are preliminary or that represent ongoing research, interim analyses, and/or unsupported opinion. Faculty in this activity may discuss information about pharmaceutical agents that is outside of US Food and Drug Administration approved labeling. This information is intended solely for continuing medical education and is not intended to promote off-label use of these medications. If you have questions, contact the medical affairs department of the manufacturer for the most recent prescribing information.

COMMERCIAL SUPPORT ACKNOWLEDGMENT

This activity is supported by an educational grant from Boehringer Ingelheim Pharmaceuticals, Inc.

DISCLAIMER

The France Foundation presents this information for educational purposes only. The content is provided solely by faculty who have been selected because of recognized expertise in their field. Participants have the professional responsibility to ensure that products are prescribed and used appropriately on the basis of their own clinical judgment and accepted standards of care. The France Foundation assumes no liability for the information herein.

COPYRIGHT INFORMATION

Copyright © 2015 The France Foundation. Any unauthorized use of any materials on the site may violate copyright, trademark, and other laws. You may view, copy, and download information or software ("Materials") found on the Site subject to the following terms, conditions, and exceptions:

• The materials are to be used solely for personal, noncommercial, informational and educational purposes. The materials are not to be modified. They are to be distributed in the format provided with the source clearly identified. The copyright information or other proprietary notices may not be removed, changed, or altered.
• Materials may not be published, uploaded, posted, transmitted (other than as set forth herein), without The France Foundation's prior written permission.

PRIVACY POLICY

The France Foundation protects the privacy of personal and other information regarding participants and educational collaborators. The France Foundation will not release personally identifiable information to a third party without the individual's consent, except such information as is required for reporting purposes to the ACCME.

The France Foundation maintains physical, electronic, and procedural safeguards that comply with federal regulations to protect against the loss, misuse or alteration of information that we have collected from you.

Additional information regarding The France Foundation's Privacy Policy can be viewed at http://www.francefoundation.com/privacy.

CONTACT INFORMATION

If you have questions about this CME activity, please contact The France Foundation at 860-434-1650 or This email address is being protected from spambots. You need JavaScript enabled to view it..