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ADDRESSING THE CHALLENGES IN RISK ASSESSMENT AND RISK MANAGEMENT IN MULTIPLE SCLEROSIS

Presented by the Johns Hopkins University School of Medicine.

THIS ACTIVITY IS SUPPORTED BY AN EDUCATIONAL GRANT FROM BIOGEN IDEC.

GOAL

To provide neurologists and other healthcare providers with up-to-date information regarding clinical considerations of risk assessment and risk management in multiple sclerosis.

INTENDED AUDIENCE

TThis activity is designed for neurologists and other healthcare providers with roles in the diagnosis and treatment of multiple sclerosis. No prerequisites required.

LEARNING OBJECTIVE

At the conclusion of this activity, the participant will demonstrate the ability to:

  • Describe the key data to consider in the assessment and management of risk of multiple sclerosis (MS) therapies.
  • Discuss the balance required in managing the risk of MS itself and the risk of therapies to treat MS.
  • Assess current practice of risk/benefit assessment in light of proposed alternatives.
  • Design a model for the assessment of risk and risk management of MS therapies within their own practice.
  • Outline the issues to consider in the prioritization of data in conducting a risk/benefit assessment.
ACCREDITATION STATEMENT

The Johns Hopkins University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT

The Johns Hopkins University School of Medicine designates this enduring material for a maximum of 2.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

The estimated time to complete this educational activity: 2 hours.

Release date: March 15, 2012. Expiration date: March 15, 2013.

HOW TO RECEIVE CREDIT

After reading this monograph, participants may receive credit by completing the CME test, evaluation, and receiving a score of 70% or higher.

FACULTY/PLANNERS
Elliot M. Frohman, MD, PhD, FAAN
Professor of Neurology and Ophthalmology
Kenney-Marie Dixon Pickens Distinguished Professor of MS Research
Irene Wadel and Robert Atha Distinguished Chair in Neurology
Director, MS Program and Clinical Center for MS
University of Texas Southwestern Medical Center
Dallas, Texas

Benjamin M. Greenberg, MD, MHS
Director, Transverse Myelitis and Neuromyelitis Optica Program
Deputy Director, MS Center
University of Texas Southwestern Medical Center
Dallas, Texas

John Ratchford, MD
(Johns Hopkins Activity Director)

Assistant Professor of Neurology
Johns Hopkins University School of Medicine
Baltimore, Maryland

Robert Zivadinov, MD, PhD, FAAN
Director, Buffalo Neuroimaging Analysis Center
Professor of Neurology
Jacobs Neurological Institute
School of Biomedical Sciences
State University of New York at Buffalo
Buffalo, New York

Activity Planners
Philip Adelman, MD; Murtaza Amir, MD; Mohammad Aslam, MD; Laura Balcer, MD, MSCE; Laura Banks, MD; Donald Barone, DO; Lakshmi Beeravolu, MD; Paul Volker Bertrand, DO; Richard Beyer, MD; Cynthea Blake, MD, PhD; David Brandes, MS, MD, FAAN; Nicholas Capozzoli, MD; Maya Carter, MD; Jonathan Charney, MD; Hector Colon, MD; Heidi Crayton, MD; Maria Diaz, MD; Simon Fishman, MD; Steven Galetta, MD; Batya Gorin, MD; Aneeta Gupta, MD; William Hicks, MD; Roderick Hines, MD; Marianne Jacobs, DO; Musaid Khan, MD; John Kilian, MD; Brian Kirschner, MD; Lisa Leschek-Gelman, MD; Jin Jun Luo, MD, PhD; Mark Mandelbaum, MD; Collin McClelland, MD; Bennett Myers, MD; Anil Nair, MD; Jiwon Oh, MD; Carl Orfuss, MD; Perry Richardson, MD; Rodrigo Rodriguez, MD; Ted Rothstein, MD; Shiv Saidha, MD; Navdeep Sangha, MD; Kenneth Sharlin, MD, MPH; Jiong Shi, MD; Jason Silversteen, DO; Ryan Walsh, MD; Fred Weinblatt, MD; Tzu-Ching Wu, MD; and Kevin Xie, MD.

FULL DISCLOSURE POLICY AFFECTING CME ACTIVITIES:
As a provider approved by the Accreditation Council for Continuing Medical Education (ACCME), it is the policy of the Johns Hopkins University School of Medicine Office of Continuing Medical Education (OCME) to require signed disclosure of the existence of financial relationships with industry from any individual in a position to control the content of a CME activity sponsored by OCME. Members of the Planning Committee are required to disclose all relationships regardless of their relevance to the content of the activity. Faculty are required to disclose only those relationships that are relevant to their specific presentation. The following relationships have been reported for this activity:

Faculty/Planners
Dr Frohman reports serving as a consultant/advisor for Abbott, Acorda Therapeutics, Biogen Idec, Genzyme, Novartis, and Teva Neuroscience. Dr Greenberg reports serving as a consultant/advisor for Applied Clinical Intelligence, Biogen Idec, DioGenix, Greater Good Foundation, and Sanofi-Aventis; receiving grants/research funding from Accelerated Cure Project, Amplimmune, and Guthy Jackson Foundation; having ownership interest in DioGenix; and receiving honoraria from EMD-Serono and Multiple Sclerosis Association of America.

Dr Ratchford reports receiving grants/research funding from Biogen Idec and Novartis; having ownership interest in Merck & Co, Inc; and receiving honorarium from Teva Neuroscience.

Dr Zivadinov reports serving as a consultant/advisor for Biogen Idec, Questcor, and Teva Neuroscience; receiving grants/research funding from Aspreva, Biogen Idec, Bracco, EMD-Serono, Genzyme, Greatbatch, Questcor, and Teva Neurosciences; and receiving honoraria from Biogen Idec, EMD-Serono, and Teva Neuroscience.

Activity Planners
Dr Balcer reports serving as a consultant/advisor for Biogen Idec and Vaccinex; receiving grants/research funding from DADs Foundation, National MS Society, and National Institutes of Health; and receiving honorarium from Novartis.

Dr Barone reports serving as a consultant/advisor for Acorda Therapeutics, Bayer, Biogen Idec, and Teva Neuroscience; receiving grants/research funding from Allergan Inc, Biogen Idec, and EMD-Serono; and receiving honoraria from Acorda Therapeutics, Bayer, Biogen Idec, EMD-Serono, and Teva Neuroscience.

Dr Beyer reports serving as a consultant/advisor for Teva Neuroscience.

Dr Blake reports receiving grants/research funding from Biogen Idec, Novartis, Octapharma, and Teva Neuroscience; and receiving honoraria from Acorda Therapeutics, Bayer, and Novartis.

Dr Brandes reports receiving honoraria from Acorda Therapeutics, Avanir, Biogen Idec, National MS Society, Questcor, and Teva Neuroscience.

Dr Capozzoli reports receiving honorarium from Teva Neuroscience.

Dr Crayton reports receiving grants/research funding from Biogen Idec, Genzyme, Novartis, Sanofi-Aventis, Teva Neuroscience, and XenoPort; and receiving honoraria from Acorda Therapeutics, Novartis, and Teva Neuroscience.

Dr Galetta reports serving as a consultant/advisor for Biogen Idec and Teva Neuroscience; and receiving honorarium from Novartis.

Dr Gupta reports receiving honorarium from Pfizer Inc.

Dr Nair reports serving as a consultant/advisor for Lilly USA, LLC; and receiving grants/research funding from Lilly USA, LLC, Medivation, Pfizer Inc, and Sanofi-Aventis.

Dr Saidha reports receiving grants/research funding from Teva Neuroscience.

Dr Sharlin reports serving as a consultant/advisor for Allergan Inc; receiving grants/research funding from Biogen Idec, Novartis, and Pfizer Inc; and receiving honorarium from Allergan Inc.

Dr Silversteen reports receiving honorarium from Biogen Idec.

No other planners have indicated that they have any financial interests or relationships with a commercial entity.

Note: Grants to investigators at The Johns Hopkins University are negotiated and administered by the institution that receives the grant, typically through the Office of Research Administration. Individual investigators who participate in the sponsored project(s) are not directly compensated by the sponsor, but may receive salary or other support from the institution to support their effort on the project(s).

Off-Label Product Discussion:
No faculty member has indicated that their presentation will include information on off-label products.

Disclaimer
The opinions and recommendations expressed by faculty and other experts whose input is included in this program are their own. This enduring material is produced for educational purposes only. Use of Johns Hopkins University School of Medicine name implies review of educational format design and approach. Please review the complete prescribing information of specific drugs or combination of drugs, including indications, contraindications, warnings and adverse effects before administering pharmacologic therapy to patients.
INTERNET CME POLICY
The Office of Continuing Medical Education (CME) at the Johns Hopkins University School of Medicine is committed to protect the privacy of its members and customers. Johns Hopkins University SOM CME maintains its Internet site as an information resource and service for physicians, other health professionals, and the public. Continuing Medical Education at the Johns Hopkins University School of Medicine will keep your personal and credit information confidential when you participate in a CME Internet based activity. Your information will never be given to anyone outside of the Johns Hopkins University School of Medicine’s CME activity. CME collects only the information necessary to provide you with the services that you request.
CONFIDENTIALITY DISCLAIMER FOR CME ACTIVITY PARTICIPANT

I certify that I am participating in this Johns Hopkins University School of Medicine activity for CME-accredited training and/or educational purposes.

I understand that while I am participating in this capacity, I may be exposed to “protected health information,” as that term is defined and used in Johns Hopkins policies and in the federal HIPAA privacy regulations (the “Privacy Regulations”). Protected health information is information about a person’s health or treatment that identifies the person. I also understand that while I am participating in this capacity I will be treated as a temporary member of Johns Hopkins for purposes of the Privacy Regulations only.

I pledge and agree to use and disclose any of this protected health information only for the training and/or educational purposes of my visit and to keep the information confidential.

I understand that I may direct to the Johns Hopkins Privacy Officer any questions I have about my obligations under this Confidentiality Pledge or under any of the Hopkins policies and procedures and applicable laws and regulations related to confidentiality. The contact information is: Johns Hopkins Privacy Officer, telephone: 410-735-6509, e-mail: HIPAA@jhmi.edu.

“The Office of Continuing Medical Education at the Johns Hopkins University School of Medicine, as sponsor of this activity, has relayed information with the CME attendees/participants and certify that the visitor is here for training, education and/or observation purposes only.”

Johns Hopkins University School of Medicine
Office of Continuing Medical Education
720 Rutland Avenue/ Turner 20
Baltimore, Maryland 21205-2195
Reviewed & Approved by: General Counsel, Johns Hopkins Medicine (4/1/09)

HARDWARE & SOFTWARE REQUIREMENTS

Pentium 800 processor or greater, Windows 98/NT/200/XP or Mac OS 9/X or later, Microsoft Internet Explorer, Safari, Firefox, Windows Media Player 9.0 or later Flash player, 128 MB of RAM Monitor settings: High color at 800 x 600 pixels, Sound card and speakers, Adobe Acrobat Reader.

ACTIVITY
Instructions: The following monograph consists of 2 sections: a proceedings article and a CME post-test. Both sections must be completed to receive CME credit.

PROCEEDINGS
Addressing Challenges in Risk Assessment and Risk Management in Multiple Sclerosis

Elliot M. Frohman, MD, PhD, FAAN, Benjamin M. Greenberg, MD, MHS, John Ratchford, MD, and Robert Zivadinov, MD, PhD, FAAN

POST-TEST
procced to pretest




Johns Hopkins Advanced Studies in Medicine (ISSN-1558-0334), is published by Galen Publishing, LLC, d/b/a ASiM, PO Box 340, Somerville, NJ 08876. (908) 253-9001. Copyright ©2012 by Galen Publishing. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, without first obtaining permission from the publisher. ASiM is a registered trademark of The Healthcare Media Group, LLC.