ACI American Conference Institute Business Information in a Global Context

This year marks 30 years since the inception of C5 Group. It is time to match our brand with the dynamic strides we have made. See inside for details…


January 26-27, 2017 • Millennium Broadway Hotel • NewYork, NY 3rd Annual Legal, Regulatory, Business And Compliance Forum On Health Outcomes Data Communications, Market Access and Value Based Contracting

Leading in-house counsel and executives having responsibility for HEOR teams, Market Access, contracting and related functions will help you:

Third Party Data Assessors and Value Frameworks – Understanding the Role of These New Players on HEOR and Market Access Determinations:

ANTICIPATE a possible expansion of FDAMA 114 through FDA Public Hearing and Request for Comments on Off-Label Use ASSESS risk associated with incorporating Amarin ruling into health outcomes communications protocols UNDERSTAND how RWE can be used in market access discussions with payors

RECOGNIZE the role of Health Technology Assessment (HTA) in international formulary determinations EXAMINE factors fueling growth and demand for value based agreements RECONCILE CMS pronouncements and demonstration projects regarding value based contracting with current fraud and abuse and antikickback law changes

Peter Neumann Director Tufts Center for the Evaluation of Value and Risk in Health

Distinguished Co-Chairs

PhRMA/ BIO Joint Principles on Responsible Sharing of Truthful andNon-Misleading Information about Medicines withHealth Care Professionals and Payers: Interpretations and Implications

WilliamA. Sarraille Partner Sidley Austin LLP

Josh Tomas O’Hara Associate General Counsel Eli Lilly and Company

Industry Insights from: BIO PhRMA National Institute of Collaborative Healthcare

Michelle Drozd, ScM Deputy Vice President, Policy & Research Pharmaceutical Research and Manufacturers of America Deborah M. Shelton Partner and Head of FDA Practice McCarter & English (former Deputy General Counsel at Biotechnology Innovation Organization (BIO) )

AbbVie Bristol Myers-Squibb Eli Lilly & Company

Eisai UCB, Inc. EMD Serono, Inc.

Interactive Pre and Post Conference Workshops

WorkshopA - January 25, 2017: Master Class on Effectively and Ethically Communicating Health Outcomes Data to Formulary Committees to AchieveMarket Access: Strategies for Preparing the AMCP Dossier and Addressing Continuing Health Outcomes Communications Dilemma Workshop B - January 27, 2017: Strategies for Negotiating, Drafting and Structuring Successful Value-Based Agreements

a C5 Group Company Business Information in a Global Context

Register Now | 888 224 2480 | AmericanConference.com/ HealthOutcomes/

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