Speakers:
Seth H. Lundy
Deputy chair of the King & Spalding FDA & Life Sciences Practice Group
With over 25 years of industry experience, he focuses his practice on federal and state regulation of pharmaceutical, biotech, and medical device manufacturers, as well as healthcare providers and suppliers, including advising on corporate compliance, the Anti-Kickback Statute, False Claims Acts, the Sunshine Act, the Food, Drug & Cosmetic Act, pricing matters, and Medicare and Medicaid billing, coding and reimbursement. Seth is widely recognized as a leading national authority on compliance with federal and state fraud and abuse laws. His practical, business-oriented approach earns accolades from sources including Chambers USA, LMG Life Sciences, Best Lawyers and Super Lawyers.
Brian A. Bohnenkamp
Partner at King & Spalding
Specializing in regulatory and compliance matters relating to drug, biotechnology and medical device companies, Brian has extensive experience counseling manufacturers on fraud and abuse laws, industry codes of conduct, federal and state transparency laws and regulations, state and local gift bans, compliance program laws and sales representative licensing requirements, as well as government ethics restrictions.
Overview:
On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) released highly anticipated revisions to its Code on Interactions with Health Care Professionals, which becomes effective on January 1, 2022. This webinar will examine key changes to the following PhRMA Code sections and their practical implications:
- Section 2 – Informational Presentations by Company Representatives – with attention to incidental meals;
- Section 5 – Third Party Educational or Professional Meetings – discussing virtual events and interactions;
- Section 6 – Consulting Arrangements – regarding consultant selection, meals, and meeting venues; and
- Changes to Section 7 – Speaker Programs – with focus on meals, alcohol, and speaker selection.
Key Take-aways:
You will benefit from an interactive discussion about:
- Benchmarking regarding how other companies plan to address the PhRMA Code changes;
- New enforcement risks raised at the federal and state levels;
- Suggestions regarding Compliance Program and policy updates that may be required by the Code changes; and
- Auditing and monitoring measures to drive compliance with the revised Code.
Who should attend?
Mid-level to Senior Compliance professionals at drug or medical device manufacturing companies, legal consultants working in the life sciences compliance industry.