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

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CME/CE Information

Activity Title Interchangeability and Extrapolation: Important Concepts Related to the Use of Biosimilars in Clinical Practice
Topic Biosimilars
Accreditation Type AMA PRA Category 1 Credits™ / ACPE CE Credits
Release Date March 31, 2016
Expiration Date March 30, 2017
Estimated Time to Complete Activity 15 minutes

LEARNING OBJECTIVE

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

  • Review key aspects of the comparability exercise for approval of biosimilars per current FDA guidance

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.
    2. If you are requesting ACPE pharmacy credit—your CE credits will be submitted electronically to the CPE Monitor.

CLICK HERE TO VIEW TECHNICAL REQUIREMENTS

ACCREDITED PROVIDER

This activity is provided by The France Foundation.

TARGET AUDIENCE

This activity is intended for physicians, pharmacists, and other health care professionals involved in the management of patients with biologic therapies.

STATEMENT OF NEED

As biosimilar guidance evolves in the United States and these biologics are studied and FDA-approved for use, it will be important for clinicians to understand how biosimilars’ characteristics overlap with, and differ from, other available biologic therapies, so that effective treatment selection and monitoring, and related patient education, can be achieved.

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 activity for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

acpe logo Pharmacists
The France Foundation is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education and will award 0.25 CEU to pharmacists who complete the activity, complete the registration and evaluation forms, and successfully pass a posttest (>70%). There is no fee to participate in this activity. This is a knowledge educational activity. Your CE credits will be submitted electronically to the CPE Monitor. CE providers must upload participant information within 60 days from the date the participant completed the activity. Please submit all evaluations and credit requests no later than 30 days after you complete this activity to ensure your credit fulfillment, as CE credit cannot be awarded past 60 days from the activity date. ACPE No. 0391-0000-16-001-H04-P.

DISCLOSURE POLICY

In accordance with the ACCME Standards for Commercial Support, The France Foundation (TFF) requires that individuals in a position to control the content of an educational activity disclose all relevant financial relationships with any commercial interest. TFF resolves all conflicts of interest to ensure independence, objectivity, balance, and scientific rigor in all its educational programs. Furthermore, TFF seeks to verify that all scientific research referred to, reported, or used in a CME/CE activity conforms to the generally accepted standards of experimental design, data collection, and analysis. TFF is committed to providing learners with high-quality CME/CE activities that promote improvements in health care and not those of a commercial interest.

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–Activity Faculty

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

DISCLOSURE OF UNLABELED USE

TFF requires CME faculty (speakers) to disclose when products or procedures being discussed are off label, unlabeled, experimental, and/or investigational, 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. TFF does not recommend the use of any agent outside of the labeled indications. 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 Hospira, a Pfizer company.

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 © 2016 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..

 

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