It is more important than ever to connect and share ideas. The Law Over Lunch series offers FDLI members the exclusive opportunity to engage in facilitated virtual discussions over lunch on topics of interest to the food and drug law community. This event features unique and co-occurring discussion groups, limited to ten attendees to encourage fruitful conversation. This member-only benefit is a chance to closely learn from, educate, and network with other professionals in the field on new and pertinent topics
Table Topics and Facilitators
Resuming FDA Inspections: Are You Ready?
Andrea Chamblee, Adjunct Associate Professor, Medical and Regulatory Affairs, George Washington University
Regulatory Counsel, FDA Office of Regulatory Affairs
State Law Considerations When Advertising Pharmaceuticals
Jennifer A. Romanski, Principal, Porzio, Bromberg & Newman P.C.
Cannabis Crossroads: Advising Clients on Practical Pathways in the Current Climate
Daniel Wang, Director, Pinney Associates, Inc.
Andrea Chamblee is the Director of Compliance Policy, Office of Enforcement, Office of Regulatory Affairs (ORA), FDA. She has 25 years of progressively increasing experience and responsibilities developing, communicating and implementing regulatory and compliance initiatives for FDA and for Industry. She represented the Centers during the drafting of compliance policies including Application Integrity and debarment, and assisted the FDA Presiding Official during a clinical investigator disqualification hearing. Ms. Chamblee went to the Commissioner’s Office to work on implementation and passage of legislation. She served at FDA’s Office of Chief Mediator and Ombudsman/Product Jurisdiction Office for five years. After 1997, she worked in industry, analyzing and articulating compliant strategies for manufacturers and clinical investigators. Ms. Chamblee has been teaching Introduction to FDA Regulatory Affairs at Johns Hopkins University since 2005. She returned to FDA in 2009 as a regulatory counsel. She is regulatory affairs certified (RAC) and was inducted into the first class of RA Fellows at RAPS. Ms. Chamblee received both her BS, cum laude, and her JD from the University of Maryland.
Jennifer 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 at Porzio Life Sciences, LLC, a wholly owned subsidiary of the law firm. 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 and patients, grants and continuing medical education programs, co-marketing programs, FDA enforcement activity, and sample accountability and PDMA requirements. She has drafted and reviewed contracts with co-promotion partners, direct mail companies, medical publication facilitators, and market research organizations. She has also 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 federal and state marketing disclosure laws and reporting, as well as price transparency laws.
Daniel Wang is Director, Cannabinoids and New Dietary Ingredients at PinneyAssociates, a public health and regulatory consulting firm in Bethesda, MD. At Pinney, Daniel provides regulatory and strategic counsel for clients developing FDA regulated products, particularly those derived from cannabis and cannabinoids. His areas of focus include regulatory issues identification, safety and toxicology evaluation, and abuse potential assessment. January 14, 2021
12:00-1:00 PM
Registration is open to FDLI members only and is first come, first served.
This is a complimentary virtual event.
For questions, please contact Claire Day.
