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The Evolving Role of Field-based Medical in the Current Regulatory Environment
Session Chair(s)
Hilary Mandler, PharmD
Sr Dir, med strategy
Supernus Pharmaceuticals, United States
The life science industry continues to face challenges as additional regulations, investigations, and Corporate Integrity Agreements (CIAs) are being executed by the government. Although many Pharmaceutical and Device companies have implemented robust data systems and compliance infrastructures, the government is increasingly focused on identifying and mitigating compliance risks within the industry. Medical Science Liaisons, by virtue of their field-based roles, have increasingly become under scrutiny in these CIAs as the government’s distinction between scientific exchange and promotion remains unclear. This session will focus on how some of the recent CIAs have impacted the MSL role, specifically relating to scientific engagement, scientific exchange, and the selection of a customer management system to document activities while mitigating risk.
Learning Objective : At the conclusion of this session, participants should be able to: - Recognize the high compliance risk areas for MSLs based upon recent CIAs - Discuss the impact of compliance and risk mitigation on the evolution of the MSL role and scientific engagement models - Identify three key compliance driven attributes you should consider when evaluating and selecting a customer engagement system
Speaker(s)
Faculty
Krystene Woodard, PharmD
SHIRE, United States
Associate Director, Behavioral Health MSL Team
Faculty
Hilary Mandler, PharmD
Supernus Pharmaceuticals, United States
Sr Dir, med strategy
Faculty
Chris Paap, PharmD
Pfizer Inc - Medicines Development Group, United States
Team Leader/Senior Director Vaccines & Infectious Diseases Field Based Medical
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