Seven Ropes & Gray attorneys will present five sessions at the 26thAnnual Pharmaceutical and Medical Device Ethics and Compliance Congress in Washington, D.C. October 22-24.
The forum for compliance professionals, legal counsel, regulators and industry consultants covers pharmaceutical and medical device topics including key laws, regulations, guidance and policy developments, among others.
Attorneys participating in the Congress include:
Health care partners Eve Brunts and Margaux Hall and health care counsel Alison Fethke will present on the panel titled “Patient-Oriented Commercial Models: Legal and Market Access Considerations.” The panelists will address topics including identifying trends and common structures in patient-directed health care initiatives; providing an overview of potential legal considerations; examining recent government scrutiny and enforcement actions, and offering options to mitigate implementation risk.
Christine Moundas, health care partner and co-head of the firm's digital health initiative will speak on the panel titled “State Consumer Privacy Laws—Compliance Tips for Pharma and Med Device Companies.” The panel will explore the new laws and requirements, discuss a risk-based approach to building and refining data compliance programs, and share practical advice for how to achieve credible compliance within an increasingly complex web of requirements.
Samantha Barrett Badlam, litigation & enforcement partner, will present on the panel “External Funding Risks and Mitigation—Latest Trends in Exhibit & Display and Sponsorship Requests.” The panel will examine the recent upticks in the complexity and legal risks associated with external funding submissions and events submitted by HCP-connected organizations, which could implicate the Anti-Kickback Statute and False Claims Act.
Joshua Levy, litigation & enforcement partner and former U.S. Attorney for the District of Massachusetts, U.S. Department of Justice, will speak on the “Former Government Officials” plenary session. The session, which will be moderated by Medtronic’s Chief Ethics & Compliance Officer at Medtronic, as well as distinguished former leaders from the DOJ and HHS OIG will cover insights into enforcement trends, shifting regulatory priorities, and the evolving role of compliance across public and private sectors.
Jamie Darch, health care partner, will present on the panel “Examining Business Relationships and Compliance Risks with Pharmacy Benefit Manager (PBM) Arrangements.” The panel will discuss increased regulatory scrutiny on PBMs, their position within the pharmacy supply chain, and their arrangements with pharma manufacturers, highlighting key compliance considerations for PBM partnerships.
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