September 13-14, 2018 | Boston, MA
CBI’s 4th Annual Compliance Congress for Specialty Products explores the unique compliance challenges for specialty bio/pharmaceutical companies, pre- and post-commercialization.
While specialty products are immensely valuable to patients, they also bring unprecedented risks for manufacturers. A comprehensive compliance program is essential to correctly assessing risks, including patient assistance programs, non-commercial activities, third-party relationships and pharmacy contracting.
At this meeting, take the opportunity to identify and address the top risk areas for specialty product manufacturers and compare strategies for promoting a compliant culture within your organization.
Register by 7/27/2018 and receive $400* off the standard rate with discount code SPC400.
Valuable Insights from 35+ Thought Leaders, Including:
- Gregg Shapiro, Assistant U.S Attorney, Chief of Affirmative Civil Enforcement Unit, U.S Department of Justice (Boston)
- Charles Graybow, Assistant U.S. Attorney, U.S. Attorney's Office, District of New Jersey
- Bill Hrubes, Vice President, Chief Compliance Officer, ACell, Inc.
- Shoshanna Clark, Head of Operations, NA Ethics & Business Integrity, Sanofi
- Alessandra Ravetti, Executive Director and Assistant General Counsel, Regeneron Pharmaceuticals, Inc.
- Trish Shorey, Privacy Officer, Global Compliance and Risk Management, Shire
- Heidy Abreu, Vice President, Legal and Corporate Secretary, Axcella Health, Inc.
- Kelly Pitt, Director, Legal & Compliance, Sobi, Inc.
- Amy Wilson, MBA, MSJ, Director, Enterprise Compliance, Alexion Pharmaceuticals
- Alessandro Martuscelli, Chief Global Therapeutics Counsel, Bioverativ
- Chad Morin, Senior Director, Healthcare Compliance, bluebird bio
- Brian Conner, Vice President, Head of Corporate Compliance, Strongbridge Biopharma plc
- Sarah Whipple, Senior Corporate and Compliance Counsel, Akebia Therapeutics, Inc.
- David Ryan, Vice President, Associate General Counsel, Chief Compliance Officer, Haemonetics Corporation
- Create a balance between effective patient assistance programs and maintaining compliant practices
- Address the legal issues related to “proactive” versus “reactive” presentations around disease state
- Gain insight into operational safeguards around copay assistance and charitable donations
- Determine if a nurse educator program is necessary and where it should sit within the organization
- Review current and pending state transparency and disclosure legislation
- Assess the controls that compliance or legal need to put in place to ensure that value-based agreements comply with the Anti-Kickback Statute
- Examine the changes in E.U. privacy laws and discuss why it matters to U.S. companies
*Offer expires July 27, 2018; applies to standard rates only and may not be combined with other offers, category rates, and promotions or applied to an existing registration.
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