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.
Please only sign up for one discussion as they will take place at the same time.
Table Topics and Facilitators
The Family Smoking Prevention and Tobacco Control Act: The Good, The Bad and The Ugly?
John Pritchard, Vice President of Regulatory Science
22nd Century Group, Inc.
Challenges in Developing Co-labeled Combination Products in US
Andy Papas, Vice President of Regulatory Affairs
NSF International
Marijuana and Its Possible International Marketing
José Alberto Campos Vargas, Partner
Sánchez Devanny
JOHN PRITCHARD joined 22nd Century Group, Inc. as Vice President of Regulatory Science in April, 2019. Prior to that time, Mr. Pritchard was the Head of Regulatory Science for Imperial Brands, where he led the company’s technical regulatory strategy and external scientific engagement on global product regulation. During his 13 years at Imperial Brands, Mr. Pritchard also held a number of key management roles in product stewardship, compliance, research, and regulatory engagement. Before joining Imperial Brands, Mr. Pritchard was a Toxicologist with both the UK Health Protection Agency (now, Public Health England) and Charles River, a leading global contract research organization for the pharmaceutical industry. Mr. Pritchard received a Master of Science Degree in Toxicology from the University of Birmingham, England and his Bachelor of Science Honors Degree in Pharmacology from the University of Aberdeen, Scotland.
ANDY PAPAS currently serves as Vice President of Regulatory Affairs at NSF Health Sciences Pharma Biotech Consulting. Dr. Papas provides strategic leadership and regulatory guidance on global regulatory affairs, quality, and drug development programs. He has almost 30 combined years of experience in the FDA regulated pharmaceutical, biotechnology, and combination product industry. This encompasses 18 Years of Regulatory Affairs experience in industry and consulting plus 11 Years at FDA in research and compliance of pharmaceuticals, radiopharmaceuticals, and medical devices. In addition, he also has 11 years of experience managing R&D Analytical and Characterization laboratories spanning from early development to commercial products. Dr. Papas’ primary areas of expertise include US Regulatory Affairs; regulatory strategy for clinical development through post approval changes; leading, reviewing, and/or authoring FDA submissions (IND, NDA, BLA, ANDA, 505(b)(2), RFD, Orphan drug designation, combination products, etc.) and/or leading agency meetings (ex. PIND, EOP2, PNDA, type C, etc.) for pharma/biotech drug products; additional experience includes: biosimilars, orphan drugs, CMC requirements, US combination products and international requirements for biologics.
JOSÉ ALBERTO CAMPOS-VARGAS is a partner at Sánchez Devanny who leads the Life Sciences practice and co-heads the International Trade and Customs practice group. He has more than 15 years of experience advising clients operating in regulated sectors on regulation and operational matters, and on international trade matters. Alberto is skilled in health law, and in the laws regulating food, non-alcoholic and alcoholic beverages, medicines and medical devices, cosmetic perfume and beauty products, and tobacco products. He is also skilled in international trade and customs matters. He has advised clients on Mexican free trade agreements, import duties, export development programs, customs and non-customs requirements, and international trade issues in mergers, acquisitions, restructurings and privatizations. He has successfully represented national and foreign clients in customs and international trade administrative proceedings and litigation, as well as in negotiations with governmental authorities and in verification processes related to customs and foreign trade.July 15, 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.
Please only sign up for one discussion as they will take place at the same time.
For questions, please contact Tess Garraty.
