Priscilla Hollander, MDPriscilla Hollander, MD
Department of Endocrinology
Baylor Endocrine Center
Dallas, Texas

 

Craig W. Spellman, DO, PhDCraig W. Spellman, DO, PhD
Professor
Associate Dean Research
Director, Regional Office Clinical Trails
Texas Tech University Health Science Center
Odessa, Texas

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CME/CE Information

Activity Title Preparing for the Wave of Biosimilars
Topic Biosimilars and Diabetes
Accreditation Type AMA PRA Category 1 Credits™, ACPE
Release Date June 30, 2016
Expiration Date June 29, 2017
Estimated Time to Complete Activity 15 minutes

LEARNING OBJECTIVES

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

  • Define biosimilars, on the basis of FDA definition
  • Categorize the differences between biosimilars and originator (reference) biologics, as well as the difference between the terms biosimilar and generic
  • Examine key aspects of current FDA guidance that inform the health care provider’s understanding of criteria for approval, manufacturing, and naming

ACTIVITY FACULTY

Priscilla Hollander, MD
Department of Endocrinology
Baylor Endocrine Center
Dallas, Texas

Craig W. Spellman, DO, PhD
Professor
Associate Dean Research
Director, Regional Office Clinical Trails
Texas Tech University Health Science Center
Odessa, Texas

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. ‰This CME/CE activity is a game and by design, participation requires learners to answer knowledge questions for the duration of play. Learners will be given a score to show them how well they did, at which time the correct answer rationale will be shared. Completion of each activity constitutes a passing score. No posttest is given.
  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 quality of the instructional process; the perception of enhanced professional effectiveness; the perception of commercial bias; and his/her views on future educational needs.
  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.
CLICK HERE TO VIEW TECHNICAL REQUIREMENTS

ACTIVITY PROVIDER

This activity is provided by The France Foundation.

TARGET AUDIENCE

Family physicians, osteopathic physicians, and other health care providers involved in the primary care management of patients with diabetes.

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.

Nurses
Nurses who are certified by the American Nurses Credentialing Center (ANCC) may utilize activities that are certified by ACCME-accredited providers toward their requirement for certification renewal by the ANCC. A certificate of attendance will be provided by The France Foundation, an ACCME-accredited provider.

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−Content Creators

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

  • Priscilla Hollander, MD has served on an advisory board for Lilly, Merck, and Novo Nordisk.


The following faculty report that they have no relevant financial relationships to disclose:

  • Craig W. Spellman, DO, PhD

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 independent educational grant from Boehringer Ingelheim Pharmaceuticals, Inc. and Lilly USA, LLC.

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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