Gary H. Lyman, MD, MPHGary H. Lyman, MD, MPH
Co-Director
Hutchinson Institute for Cancer Outcomes Research
Professor of Medicine
University of Washington

 

Edmund J. Pezalla, MD, MPHEdmund J. Pezalla, MD, MPH
Vice President
Pharmaceutical Policy and Strategy
Aetna
Hartford, Connecticut

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CME/CE Information

Activity Title Clinician and Payer Perspectives on the First Biosimilar Approved in the US
Topic Biosimilars
Accreditation Type AMA PRA Category 1 Credits™, ACPE – No longer available for credit
Release Date September 2015
Expiration Date September 30, 2016
Estimated Time to Complete Activity 30 minutes

LEARNING OBJECTIVE

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

  • Describe current and emerging biosimilars in the US

ACTIVITY FACULTY

Gary H. Lyman, MD, MPH
Co-Director
Hutchinson Institute for Cancer Outcomes Research
Professor of Medicine
University of Washington

Edmund J. Pezalla, MD, MPH
Vice President
Pharmaceutical Policy and Strategy
Aetna
Hartford, Connecticut

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/CE information.
  3. Complete the CME/CE 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/CE 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/CE 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

ACTIVITY 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 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.

Pharmacists
The France Foundation is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education and will award 0.5 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-based 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. 0391-0000-15-191-H04-P.

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

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.

Planning Committee Disclosures

CLICK HERE to see the Planning Committee disclosures

Faculty Disclosures

The following faculty report that they have relevant financial relationships to disclose:

  • Gary H. Lyman, MD, MPH, has received grants or research support from Amgen.
  • Edmund J. Pezalla, MD, MPH is an employee of Aetna.

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 and (insert commercial supporter(s) here) assume 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..

 

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