Jennifer Romanski

Principal at Porzio, Bromberg & Newman

Speaker

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.