Released: 2/9/2010
Expires: 2/9/2011
Statement of Need
This medical education program will not only educate medical professionals on the logistics of the REMS requirement, but will also discuss how this program might present various challenges and opportunities in the healthcare setting for all stakeholders.

Target Audience
This continuing medical education program is designed for all healthcare professionals.

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

• Review the recent legislative updates relative to monitoring safety and minimizing risk in the current value-based healthcare syste
• Describe the recent FDA regulatory changes involving risk evaluation and mitigation strategies (REMS) for specific drugs and biologic
• Examine the value and utility of specific biologics, based on evidence-based clinical, pharmacoeconomic data, and case studie
• Discuss the importance of planning for REMS at the earliest possible stage and considering its long-term implications for all key stakeholders, including patients, manufacturers, payers, and provider

Physician Accreditation
The University of Cincinnati designates this activity for a maximum of 1.5 AMA PRA Category 1 Credit(s)^TM.

The University of Cincinnati is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Registered Pharmacy Designation
MLI is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Completion of this activity provides for 1.5 contact hours (0.15 CEUs) of continuing education credit. The universal program number for this activity is 0468-9999-09-043-H01-P.

Instructions for Credit
There is no fee for this activity. To receive credit, participants must complete this activity in its entirety and complete the posttest and evaluation. The posttest and evaluation can be completed online at www.coexm.com/WEBSYMP709.html. Upon completion of the evaluation and scoring a 70% or better on the posttest, you will immediately receive your certificate online. If you do not achieve a score of 70% or better on the posttest, you will be asked to take it again. Please retain a copy of the Certificate for your records.

For questions regarding the accreditation of this activity, please contact Medical Learning Institute at (609) 333-1693 or cgusack@mlicme.org.

Disclosure Statement
MLI, Inc. adheres to all Accrediting Boards Policies and Procedures, including the Standards for Commercial Support regarding industry support of continuing medical education. In order to resolve any identified conflicts of interest, disclosure information is provided during the planning process to ensure resolution of any identified conflicts. Disclosure of planning committee and faculty relationships with commercial supporters, as well as the discussion of unlabeled/investigational use of any drug, device, or procedure by the faculty, will be made known prior to start of the lecture.

The associates of the University of Cincinnati, Medical Learning Institute, Inc. and Center of Excellence Media, LLC have no financial relationships to disclose.

Faculty Disclosures
Jeff Brady, MD, MPH, has nothing to disclose. He does not intend to discuss non-FDA-approved or investigational use of any product/device.

Thomas Clark, RPh, MHS, CGP, has nothing to disclose. He does not intend to discuss non-FDA-approved or investigational use of any product/device.

Caroline York, MBA, has nothing to disclose. She does not intend to discuss non-FDA-approved or investigational use of any product/device.


*Content will include non-FDA-approved uses.

Disclaimer
The information provided in this CME/CE activity is for continuing education purposes only and is not meant to substitute for the independent medical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient's medical condition.

Trade names used in this supplement are for the learner's reference only. No promotion of or bias toward any product should be inferred.