Join Porzio in this session that will help med device compliance leaders with messaging, designing, and implementing risk assessments, a key component of an effective healthcare compliance program.
Strategic Risk Assessment in Medical Device Compliance: Proactive Strategies for Effective Risk Management Webinar
January 23, 2025
11:00 AM – 12:00 PM
Strategic Risk Assessment in Medical Device Compliance: Proactive Strategies for Effective Risk Management Webinar
January 23, 2025
11:00 AM – 12:00 PM
Join Porzio, Bromberg, & Newman, P.C. in this webinar discussion: In the rapidly evolving landscape of medical device regulation, a thorough risk assessment is essential to identify, mitigate, and manage compliance risks. This interactive session provides in-house compliance teams with actionable insights into conducting comprehensive risk assessments tailored specifically to the medical device sector.
Attendees will gain practical knowledge on risk identification, prioritization, assessment methodologies, and compliance risk mitigation strategies that reduce regulatory exposure. Through real-world case studies and discussion of industry best practices, this session will help med device compliance leaders with messaging, designing, and implementing risk assessments, a key component of an effective healthcare compliance program.
Meet The Speakers
Jennifer A. Romanski, Principal, Life Sciences Legal, Regulatory, and Compliance – Porzio, Bromberg & Newman, P.C.
Ms. Romanski, chair of the firm’s Life Sciences Legal, Regulatory, and Compliance Practice Group, has broad experience counseling pharmaceutical, biotech and medical device companies in regulatory and compliance matters, including preparation of corporate compliance programs, advertising and promotion activities, medical publication planning, interactions with healthcare practitioners, grants and continuing medical education programs, FDA enforcement activity, and sample accountability and PDMA requirements. She worked for many years in Porzio’s Key Client program where she served as part of the in-house legal team for various pharmaceutical companies several days a week. She has also served as acting compliance director at a large pharmaceutical company, where she was involved in over twenty compliance reviews and investigations.
She has drafted contracts with co-promotion partners, direct mail companies, medical publication facilitators, and market research organizations. She has provided counsel on implementation of compliance measures for research and development companies, with emphasis on pre-market requirements, clinical trial registration and disclosure, and patient recruitment. In addition, she regularly counsels clients on compliance with state marketing disclosure reporting laws and the new requirements under the Patient Protection and Affordable Care Act, including compliance with healthcare practitioner transparency requirements.
Michelle D. Axelrod, Principal, Life Sciences Legal, Regulatory, and Compliance – Porzio, Bromberg & Newman, P.C.
Michelle Axelrod is a principal of Porzio, Bromberg & Newman P.C. in the Life Sciences Compliance and Regulatory Counseling team, a member of the firm’s Management Committee, and a Board Member of Porzio Compliance Services, a wholly-owned subsidiary of the firm. Michelle has over 25 years of experience addressing legal and compliance issues impacting companies in the life sciences industry; 15 years as in-house counsel. Michelle advises pharmaceutical, biotech, and medical device clients on legal and compliance issues through all stages of development, from clinical stage through commercialization. She counsels on clinical trial related compliance matters, communications and recruitment matters, and on product commercialization and related sales, marketing and reimbursement activities, including fraud and abuse. She also advises on privacy matters and supports clients’ compliance initiatives, including conducting compliance assessments/audits, and developing and implementing compliance programs, policies/SOPs, training, and monitoring and auditing programs. Michelle also negotiates, drafts and reviews various types of agreements common to the life sciences industry.
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