Jennifer A. Romanski

Principal

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Overview

Jennifer A. Romanski is a principal of Porzio, Bromberg & Newman and a co-chair of the firm’s Life Sciences Compliance and Regulatory Counseling Department.

Ms. Romanski is also a Vice President of Regulatory and Compliance Services and Chief Privacy Officer of Porzio Life Sciences, LLC, a wholly owned subsidiary of the law firm. In collaboration with the other Directors of Regulatory and Compliance Services, Ms. Romanski is responsible for ensuring that all Porzio Life Sciences products are relevant to the needs of the industry and working with other company personnel to create new products.

Ms. Romanski 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.

Recognition

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  • 1998 Morris County Bar Association Mock Trial Finalist

Memberships

  • Advertising and Promotion Conference Planning Committee (FDLI), 2018
  • Drug Information Association (DIA), 2012 - Present
  • Food and Drug Law Institute (FDLI), 2016
  • Regulatory Affairs Professionals Society (RAPS), 2010 - Present

Speaking Engagements

  • "HCP Engagement & Transparency: Best Practices for Managing Risk and Avoiding Enforcement Action" Transparency & Aggregate Spend Conference, 12/06/2021
  • "Risk Reduction in a New Generation of TV Ads – Saving Time and Increasing Consumer Comprehension," FDLI Advertising and Promotion for Medical Products Conference, 10/15/2021
  • "Anticipating Reporting Responsibilities and Making Sure Your Company is Prepared," Porzio Life Sciences Webinar, 9/15/2021
  • "Enforcement Action Current Trends: Compliance Takeaways from the Incyte Complaint," Porzio Life Sciences Webinar, 6/30/2021
  • "Compliance Challenge:  Federal, State and International Transparency, Disclosures and Reporting; Part 4 of Four-Part Series, Culture, Effective Compliance Program Development and Implementation, Government Expectations and Assessing Your Risk Profile," Medtech Compliance Virtual Bootcamp, 3/11/2021
  • "Compliance Challenge:  Grants, Donations and Other Funding; Part 3 of Four-Part Series, Culture, Effective Compliance Program Development and Implementation, Government Expectations and Assessing Your Risk Profile," Medtech Compliance Virtual Bootcamp , 3/09/2021
  • "Compliance Challenge:  Healthcare Professional Engagements; Part 2 of Four-Part Series, Culture, Effective Compliance Program Development and Implementation, Government Expectations and Assessing Your Risk Profile," Medtech Compliance Virtual Bootcamp, 3/04/2021
  • "Compliance Framework; Part 1 of Four-Part Series, Culture, Effective Compliance Program Development and Implementation, Government Expectations and Assessing Your Risk Profile," Medtech Compliance Virtual Bootcamp, 3/02/2021
  • "State Law Considerations When Advertising Pharmaceuticals; Law Over Lunch," Food and Drug Law Institute (FDLI), 1/14/2021
  • "State of the Industry – Drug Pricing Transparency Landscape Address," 6th Edition Drug Pricing Transparency, 11/16/2020
  • "Before and Beyond Advertising: Healthy Partnerships with Disease and Patient Experts," FDLI Advertising and Promotion for Medical Products Conference, 10/30/2020
  • "What you say matters: Communication Pitfalls and Whistleblower Risks," AdvaMed Bootcamp MedTech Compliance 101/201, 10/21/2019
  • "Patient Engagement:  Challenges of Engaging Patients and Patient Groups," FDLI Advertising and Promotion for Medical Products Conference, 10/17/2019
  • "Designing a Proactive Monitoring Program as New Risks Emerge," CBI's 7th Annual Compliance Monitoring Conference, 2/27/2019
  • "Dive into the Legal Implications of Nurse Educator Programs," Bio/Pharma Compliance Congress on Non-Promotional Activities, 12/04/2018
  • "Nontraditional Venues: Are They Promotional?" FDLI Advertising & Promotion for Medical Products Conference, 10/16/2018
  • "Assess Your Organization's Training Strategy for Executing Speaker Programs," CBI's Speaker Programs Conference, 2/13/2018
  • "A Checkpoint on Regulatory and Enforcement Updates," CBI's 3rd Annual Medical Affairs & MSL Excellence Forum, 1/30/2018

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Prior Relevant Experience

  • Porzio, Bromberg & Newman, P.C., Morristown, New Jersey, Summer Associate, 1996
  • New York State Department of Law, Office of the Attorney General, Poughkeepsie, New York, Summer Intern, 1995