Jennifer A. Romanski

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Jennifer A. Romanski is a principal of Porzio, Bromberg & Newman and a member 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.

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
  • Saul, Ewing, Remick & Saul, Philadelphia, Pennsylvania, Public Service for Penn Public Interest Program, 1995–1997
Honors and Awards
  • 1998 Morris County Bar Association Mock Trial Finalist

Honors and Awards

Organizations/Memberships
  • Drug Information Association (DIA), 2012 - Present
  • Food and Drug Law Institute (FDLI), 2016
  • Regulatory Affairs Professionals Society (RAPS), 2010 - Present
Publications
  • "The Last Two Years: A Summary of 2014 - 2015 Office of Prescription Drug Promotion (OPDP) Enforcement and Relevant FDA Guidance," Porzio Life Sciences, LLC, March 1, 2016.
  • Contributor, "Getting the Deal Through - Life Sciences 2014," United States Chapter, published by Getting the Deal Through, 2014.
  • "FDA's Office of Prescription Drug Promotion (OPDP) Enforcement: A Summary of 2013 Warning and Untitled Letters," Porzio Life Sciences, LLC, February 27, 2014.
  • Contributor, "Getting the Deal Through - Life Sciences 2013," United States Chapter, published by Getting the Deal Through, 2013.
  • Contributor, "Getting the Deal Through - Life Sciences 2012," United States Chapter, published by Getting the Deal Through, February 2012.
  • "The New Reality of Sales Force Behavior and Management," FDLI Monograph Series, Vol. 2, Num 6, June 2011.
  • "Issued Less Frequently, DDMAC Letters Still Offer Valuable Lessons," Regulatory Focus, Vol. 13, No. 7, July 2008.
  • "DDMAC Reasserts Its Oversight of Promotion Directed Not Only to Physicians, But Also to P&T Committees," Porzio Pharmaceutical Alert, Volume III, No. 4, September 11, 2007. Reprinted in Rx Compliance Report, Vol. VI, Issue 17, November 7, 2007.
  • "Porzio's Review of DDMAC Untitled and Warning Letters on Rx Drug Promotion," Porzio Pharmaceutical Alert, Volume III, No. 2, February 26, 2007.
  • "Porzio's Quarterly Review of DDMAC Untitled and Warning Letters on Rx Drug Promotion: DDMAC Launches a Broadbased Attack on a Wide Range of Promotional Materials," Porzio Pharmaceutical Alert, Volume II, No. 4, May 8, 2006.
  • "Porzio's Quarterly Review of DDMAC Untitled and Warning Letters on Rx Drug Promotion: Omit Risk Information At Your Peril," Porzio Pharmaceutical Alert, Volume II, No. 1, January 20, 2006.
  • "Porzio’s Quarterly Review of DDMAC Untitled & Warning Letters on Rx Drug Promotion: ‘Hot Button’ Issues for The FDA in Drug Advertising and Promotion," Porzio Pharmaceutical Alert, Vol. I, No. 1, October 31, 2005.
  • "The Final Sampling Regulations of the Prescription Drug Marketing Act are Alive and Well: Is Your Sampling Program Compliant?," Food and Drug Law Journal, Volume 58, Issue 4, 2003.
Speaking Engagements
  • 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.
  • "FDA's Regulatory Processes," FDLI's Introduction to Drug Law and Regulation:  The Legal Framework for Drug Regulation, New Brunswick, December 11, 2014.
  • "Proper Product Communications," AdvaMed's Compliance Essentials: Implementing An Effective Program, AdvaMed, Washington, DC, September 23, 2014.
  • "Regulation of Pharmaceutical Product Promotion," Porzio, Bromberg & Newman, P.C., Morristown, NJ, September 18, 2014.
  • “Healthcare Compliance in the Medical Device Industry – Relevant Laws, Business Missteps, Implementation Complexities," Porzio, Bromberg & Newman, Morristown, NJ, August 14, 2014.
  • “Ensure Compliance Communication of Medical and Economic Value to Improve Market Access," CBI's Commercial Compliance Congress, Philadelphia, PA, June 20, 2014. 
  • "The Sunshine Act," 10th Annual Meeting of ISMPP, (International Society for Medical Publication Professionals), Leading Through Collaboration, Arlington, VA, April 7, 2014.
  • Panelist, "A View from the Outside – Mitigate Risk and Prepare for the Future," CBI's Pharmaceutical Compliance Congress, Washington, DC, January 28, 2014.
  • "Proper Product Communications," AdvaMed Compliance Matters: Tips and Best Practices for Small and Midsize Companies, Boston, MA, November 4, 2013.
  • Moderator on Panel, "Challenges and Ideas for Implementing Efficiencies in the Promotional Review Process," Porzio Compliance Forum, "Small and Mid-Sized Life Sciences Companies Still Face Big Issues – Minimizing the Risks," Newark, NJ, October 18, 2013.
  • "FDA Advertising and Promotional Requirements – An Overview," CBI’s Promotional Compliance Conference, Enforcement Risk of Product Communications through Field force, Traditional and Social Media Channels, Philadelphia, PA, October 7, 2013.
  • Panelist, "The Sun is Shining Upon Us: The Sunshine Act and Medical Publications," International Society of Medical Publication Professionals, August 14, 2013.
  • "2012 A Year in Review: Lessons Learned from Recent FDA Enforcement," CBI’s Pharmaceuticals Compliance Congress, Washington, DC, January 29, 2013.
  • "Understand the Benefits of Proper Off-Label Compliance Training and Monitoring Field Based Sales Operations," CBS's 14th Annual Forum on Off-Label Guidelines, Philadelphia, PA, October 11, 2012.
  • "Compliance 101: A Primer for Start-Up Life Sciences Companies," New Jersey Economic Development Authority, New Brunswick, NJ, July 18, 2012.
  • "Promotion Pitfalls: From Slim Jims to Social Media," The Life Sciences Industry Under Attack—Mitigating the Risks, Seventh Annual Porzio Compliance Forum, Newark, NJ, October 14, 2011.
  • "You've Been Warned: Examining DDMAC Promotional Violations," Porzio Pharmaceutical Services, LLC Webinar, May 24, 2011.
  • "Ensuring Compliant Discussions and Dissemination of Information at Medical Meetings and Scientific Congresses," The Center for Business Intelligence 12th Annual Conference on Guidelines for Disseminating Off-Label Information, Alexandria, VA, October 6, 2010.
  • "Working Effectively With Regulators and Responding Properly When You Receive An FDA Warning," ACI Conference on Advertising, eMarketing and Promotions for the Pharmaceutical Industry, Philadelphia, PA, April, 2010.
  • "The Updated PhRMA Code on Interactions with Healthcare Professionals: Key Changes and Additions," HCPro, Inc. Webcast, August 19, 2008.
  • "Medical Science Liaisons: Real-World Scenarios for Compliance," HCPro, Inc. Webcast, July 10, 2008.
  • "Legislative Scrutiny of the Medical Device Industry: Keys to Preparing for an Ever-Changing Legal and Regulatory Landscape," ACI's 7th National Forum on Reducing Legal Risks in the Sale and Marketing of Medical Devices, Chicago, IL, June 17, 2008.
  • "Nurturing the Two-Way Street of MSL and KOL Relationship Development," CBI's 5th Annual Forum on Field-Based Dissemination of Scientific Information, Implement Effective and Compliant Medical Science Liaison Communication Strategies, Philadelphia, PA, May 19, 2008.
  • "Effective Use of Medical Science Liaisons and Avoiding Pitfalls in Off Label Communication," Regulatory Affairs Professionals Society’s (RAPS) Advertising, Promotion and Labeling Conference, Baltimore, MD, May 12, 2008.
  • "Meeting Medical Needs Without Crossing the Line: Avoiding Consequences for Off-Label Discussions," ACI's 5th National Pharma/Biotech Industry Conference on Medical Affairs, New York, New York, November 14-15, 2006.
  • "Science or Sales? - Proven Strategies for Auditing and Monitoring Medical ScienceLiaisons (MSLs)," The Center for Business Intelligence, Third Annual Forum on Field-Based Dissemination of Scientific Information, Philadelphia, PA, May 22, 2006.
  • "Regulation of Drug Marketing," Presented at Porzio, Bromberg & Newman, February and November 2005.
  • "Conducting a PDMA Audit," Presented at Porzio, Bromberg & Newman, November 2005.
  • "Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers and Federal Sentencing Guidelines," Presented at Client Headquarters, New Jersey, March–August 2005.
  • "Gifts and Grants to Healthcare Practitioners," Presented at Client Headquarters, New Jersey, July–August 2003.
  • "Grants and Educational Programs Compliance Training," Presented at Client Headquarters, New Jersey, April 2003.

Practice

Industries

Related Media

Bar Admissions

  • New Jersey, 1997
  • New York, 1998
  • United States District Court, District of New Jersey, 1998
  • United States District Court, Southern District of New York, 1999
  • United States District Court, Eastern District of New York, 1999

 

Education

University of Pennsylvania Law School, Philadelphia, Pennsylvania,
J.D., 1997

  • Book Review Editor, Comparative Labor Law Journal, 1996–1997
  • Associate Editor, Comparative Labor Law Journal, 1995–1996

University of Pennsylvania, Philadelphia, Pennsylvania, B.A., Biological Basis of Behavior, cum laude, 1994

Contact Address

100 Southgate Parkway

Morristown, NJ 07962-1997

Phone: 973.538.4006

Fax: 973.538.5146