He is Vice-Chair of the Board for the Food and Drug Law Institute and is a graduate of Brandeis University and the Rutgers School of Law – Newark. CYNTHIA SCHNEDARis Executive Vice President of Regulatory Compliance at Greenleaf Health, where she provides strategic recommendation to purchasers in the life sciences industry. She was formerly Director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research , the place she spearheaded efforts to guard the American public from unsafe and ineffective drug products by ensuring that corporations adjust to federal standards for quality and security. Schnedar previously served on the Department of Justice as Acting Inspector General and in different management positions focused on compliance and enforcement issues.

She is recognized as a leading practitioner for life sciences, food, and beverage law, and in the area of pharmaceutical and medical merchandise regulation. FREDERICK R. BALLis in the Boston workplace of Duane Morris LLP. Ball focuses his apply on aiding companies or individuals when they’re opposed to state or federal governments, together with administrative, civil and legal issues, with the FDA, FTC, DEA, CMS, OIG and other federal and state regulatory businesses. He serves as a team lead for the Duane Morris Life Sciences/Biotech trade group. He assists companies deliver product to market through patent evaluation, figuring out marketing and approval pathways, and, when needed litigation.

Prior to becoming a member of Johnson & Johnson, Cartwright was an attorney and staff chief in FDA’s Office of the Chief Counsel the place she suggested the Center for Drug Evaluation and Research on authorized and coverage points, working closely with the Offices of Policy and Legislation. She is a graduate of Washington University in St. Louis and has a JD from Yale Law School and an LLM from Georgetown University Law Center. Asha Scielzo serves as the Director of AUWCL’s Health Law and Policy Program and as an Adjunct Professor of Law.

Sonali P. Gunawardhana has joined the life science staff of Shook, Hardy and Bacon. The New to Food and Drug Law Group offers young professionals with up to six years of expertise an opportunity to attach, be taught from their friends, and improve their skills. Individuals affiliated with member organizations, those linda gaustad for judge employed by the government, and regulation college students are encouraged to participate. FDA relies on high-quality scientific data to help security and effectiveness selections.

Experienced in FDA regulation of medical units, having served greater than seven years on the Center for Devices and Radiological Health where she served as manager of the CDRH Application Integrity Policy Program and as the integrity officer for the Division of Research Monitoring. Counsels purchasers on the FDA regulatory system for the evaluation and authorization of medical devices, drawing on her firsthand data of the complexities and impacts of FDA’s informal and sometimes unwritten insurance policies and practices. WASHINGTON — Sonali P. Gunawardhana has joined the life science team of Shook, Hardy and Bacon, a legislation agency specializing in well being, science and know-how. Sonali P. Gunawardhana attracts on practically ten years of experience as an attorney at the united states