Register for September 20, 2017 Webinar


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Wednesday, September 20, 2017, 2:00 PM - 3:00 PM EDT 



Program Description 

Biosimilars Basics and Beyond: Regulating Biosimilars 

Biosimilars have the potential to produce significant health care cost savings in the United States and improve patient access to treatment options. Whether biosimilars are able to fulfill that potential depends in large part on how well they are accepted by payers, clinicians, and patients. The more managed care pharmacy professionals know about how biosimilars are developed, evaluated, approved, and regulated, the more likely they will be to have confidence in the effectiveness and safety of these agents.

This webinar—the second in a two-part series—focuses on legal and regulatory aspects of biosimilars, with an emphasis on recent FDA guidance documents and developments in patent litigation.

Learning Objectives 

At the completion of this activity, participants should be able to:

  1. Discuss how the FDA considers various types of data, including data from comparator products approved outside the United States, in making determination of biosimilarity.
  2. Explain why “indication extrapolation” is considered to be both acceptable and safe.
  3. Outline the FDA framework for designating the nonproprietary name of a biological product.
  4. Identify requirements and recommendations for post-marketing surveillance of biosimilars.
  5. Recognize how the stepwise procedure for resolving potential patent disputes (i.e., the biosimilar “patent dance”) affects the development, approval, and availability of biosimilars.
  6. Review state laws that could affect the use of biosimilars.

Target Audience 

This knowledge-based activity has been designed to meet the educational needs of pharmacists, physicians, and nurses in managed care settings.

Faculty Presenters 

 HeadshotRumore
Martha Rumore, PharmD, JD, MS, LLM, FAPhA

Of Counsel
Sorell, Lenna & Schmidt, LLP
New York, New York


 

 HeadshotWoollett
Gillian Woollett, MA, DPhil

Senior Vice President
Avalere Health
Washington, District of Columbia

 


Moderator 

Christine L. Cooper, PharmD
Education Program Manager
Academy of Managed Care Pharmacy
Alexandria, Virginia
 


Agenda 
   
2:00 pm to 2:05 pm        Welcome and Introductions
Christine L. Cooper, PharmD  
2:05 pm to 2:30 pm   The FDA and Biosimilars
Gillian Woollett, MA, DPhil 
2:30 pm to 2:50 pm   Federal and State Regulations for Biosimilars
Martha Rumore, PharmD, JD, MS, LLM, FAPhA 
2:50 pm to 3:00 pm   Audience Q&A
Christine L. Cooper, PharmD
 


ACPE UAN #: 0233-9999-17-044-L04-P

Credit: 1.0 contact hours (0.1 CEU)

Activity Type: Knowledge-based

Activity Fee: There is no fee to participate in this activity.

Joint Providership 

This activity is being provided jointly by Academy of Managed Care Pharmacy and PRIME® Education, LLC.

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Statement of Commercial Support 

This educational activity is supported by an unrestricted education grant from Sandoz, Inc. 

Fee 

This continuing education activity is provided at no cost to participants, but space is limited to the first 500 participants that join the webinar.

Continuing Education Credit - Pharmacists 

ACPE LogoThe Academy of Managed Care Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

To earn continuing pharmacy education (CPE) credit for this program, you must attend the entire session and participate in the pre- and post-test questions. Once completed, go to http://amcplearn.org to claim CPE credit. In the enrollment code redemption area, enter the enrollment code provided during the session. Complete the program evaluation and enter your NABP ID and date of birth (MMDD). Please allow 72 hours for processing and posting in your NABP account. All CPE credit for this webinar activity must be completed no later than 5:00 PM EDT on Monday, October 23, 2017. No exceptions can be made after this date.

As an ACPE-accredited provider, AMCP strictly adheres to the ACPE Standards for Commercial Support and other relevant guidelines and standards to ensure the independence of CPE activities. It is AMCP’s intent that all CPE activities be independent, objective, balanced, evidence-based and free of any commercial bias.

Continuing Education Credit - Physicians and Nurses 

JointlyAccreditedProvider 

In support of improving patient care, PRIME Education, LLC (PRIME®) is accredited by the American Nurses Credentialing Center (ANCC), the Accreditation Council for Pharmacy Education (ACPE), and the Accreditation Council for Continuing Medical Education (ACCME), to provide continuing education for the healthcare team.

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This activity was planned by and for the healthcare team, and learners will receive 1.0 Interprofessional Continuing Education (IPCE) credits for learning and change.
 

 ACCME
Physician Credit Designation Statement
PRIME® designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only credit commensurate with the extent of their participation in the activity.
 

ANCC  Nurse Accreditation Statement
PRIME® designates this activity for 1.0 contact hours.

To claim ACCME or ANCC credit for the activity please access www.primeinc.org/credit and enter the program code provided during the educational activity. 

System Technical Requirements/Viewing Requirements  

For all activities you should have a basic comfort level using a computer and navigating web sites.

This live webinar is delivered through GoToWebinar. To view minimum technical and system requirements for the webinar, please use your web browser to check your system requirements by clicking here. Space is limited to the first 500 participants that join the webinar.

The handout will be delivered via Acrobat PDF.

CPE credit will be claimed through AMCP Learn. View the minimum technical and system requirements for continuing education online learning activities by clicking here