JENNIFER A. ROMANSKI is Vice President of Porzio Life Sciences, LLC. In collaboration with the other Directors of Regulatory and Compliance Services, Ms. Romanski is responsible for ensuring that all products are relevant to the needs of the industry and working with other personnel to create new products.

Ms. Romanski is also a principal of Porzio, Bromberg & Newman P.C. and a co-chair of the firm’s Life Sciences Compliance and Regulatory Counseling team. Ms. Romanski counsels pharmaceutical and device manufacturers on federal and state fraud and abuse laws, sampling compliance, and state disclosure and prohibition laws. She develops policies and procedures and conducts training programs for clients, in connection with their comprehensive compliance programs. She evaluates grants and contributions, drug and device advertising and promotion, and marketing activities directed to healthcare professionals. Additionally, Ms. Romanski provides general business counseling on contractual issues.

She has earned the honor of sitting on the 2018 Advertising and Promotion Conference Planning Committee for the Food and Drug Law Institute (FDLI). Ms. Romanski received a J.D. from University of Pennsylvania Law School, in 1997. She earned her B.A. in Biological Basis of Behavior, cum laude, from University of Pennsylvania in 1994.

PUBLICATIONS

SPEAKING ENGAGEMENTS

  • "Industry Pulse on Off-Label – Are Policies Changing in Aftermath of Groundbreaking Rulings?" 15th Annual Pharmaceutical Compliance Congress, Washington, DC, April 25, 2018.
  • "A Checkpoint on Regulatory and Enforcement Updates," CBI's 3rd Annual Medical Affairs & MSL Excellence Forum, Philadelphia, PA, January 30, 2018.
  • "Regulatory and Legal Considerations and Criteria when using Social Media to Promote Medical Devices," 8th Annual AdvaMed Advertising and Promotion of Medical Devices Conference, Washington, DC, November 15, 2017.
  • "Enhancing Patient Centricity: Communication and Involvement," FDLI Advertising and Promotion Conference for the Drug, Medical Device and Veterinary Industries, Washington, DC, September 26, 2017. 
  • Privacy - An Overview of Life Science Company Basics from a U.S. and Global Perspective, "Privacy - Policies & Practices," Porzio, Bromberg & Newman CLE Presentation, Helsinn Therapeutics, Iselin, NJ July 11, 2017.
  • "Off-Label Communication – Regulatory Updates and Actions for 2017," Bio/Pharma Compliance Congress on Non-Promotional Activities, Philadelphia, PA, June 15, 2017.
  • "Best Practices for Risk Assessment," Moderator, Porzio Compliance Forum, Newark, NJ, February 10, 2017.
  • "Approaches for Monitoring Value Added Services and Donations or Grants to Avoid Kickback Allegations and FCPA Actions," CBI's 5th Annual Compliance Monitoring Forum, Philadelphia, PA, February 8, 2017. 
  • "A Spotlight on Regulatory and Enforcement Trends," Moderator, Medical Affairs Advancement Forum, Philadelphia, PA, January 30, 2017.
  • "FDA's Regulatory Processes," FDLI Introduction to Drug Law and Regulation, Union, NJ, October 19, 2016.
  • "Challenging Hypotheticals - What Would You Do?," Workshop Discussion Moderator, FDLI's Advertising and Promotion Conference, Washington, DC, September 28, 2016.
  • "AdvaMed MedTech Compliance 201: A Deeper Dive into the Compliance Landscape," Washington, DC, September 21, 2016.
  • "AdvaMed MedTech Compliance 101: Boot Camp," Washington, DC, September 19-20, 2016.
  • "The Evolving Evidentiary Standard for Product Claims," CBI's 16th Off-Label Guidelines, Philadelphia, PA, June 23, 2016.
  • "Compliance Tools for Implementation, Maintenance and Troubleshooting," Off-Label Regulatory Compliance Congress, Parsippany, NJ, May 11, 2016.
  • "Social Media - New Challenges and Opportunities," CBI's 13th Annual Pharmaceutical Compliance Congress, Washington, DC, April 26, 2016.
  • "Strategies for Monitoring Medical Activities to Mitigate Risks," CBI's 4th Annual Compliance Monitoring 2016, Philadelphia, PA, March 16, 2016.
  • "The Life Cycle of a Pharmaceutical Product – Advertising and Promotion," Panelist, Porzio Life Sciences Training Committee, Morristown, NJ, November 10, 2015.
  • "AdvaMed MedTech Compliance Boot Camp," Moderator, Washington, DC, November 4-5, 2015.
  • "Seeing the Big Picture in Life Sciences Law:  the Substantive Legal Developments that Women Leaders Must Know," ACI's 2nd Annual Conference on Women Leaders in Life Sciences Law, Boston, MA, July 23, 2015.     
  • "Strategies for Safe Communication of HEOR Information," CBI's Off-Label Guidelines, Philadelphia, PA, June 23, 2015.
  • "Regulation od Pharmaceutical Product Promotion, Part II," Porzio, Bromberg & Newman, P.C., Morristown, NJ, May 12, 2015.
  • "The Sunshine Act, One Year Later,"  Workshop, 11th Annual Meeting of ISMPP, Optimizing Scientific Value:  Smart and Systematic Approaches to Medical Publications, Arlington, VA, April 27, 2015.
  • "Highlights from 2014 for Promotional Review Professionals – FDA Enforcement and Guidance," Porzio Life Sciences, LLC Webinar, Morristown, NJ, January 20, 2015.

37 Ex-US Jurisdictions Served

3 Offices

370 Companies Served

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