Advancing the Vaccine Law Dialogue

Pre-conference: September 13 Washington, D.C.

Sonali Gunawardhana

Sonali Gunawardhana, Esq.

General Counsel Regulatory Law, Cardinal Health Incorporated


Ms. Gunawardhana has taught is multiple courses relating to the regulation of vaccines, including Vaccine Law, at the American University Washington College of Law.

She is Assistant General Counsel Regulatory Law at Cardinal Health Incorporated. In this role, Sonali provides regulatory and legal support to Cardinal Health’s businesses including both pharmaceutical and medical device manufacturing and distribution. Previously, she served as Chief Counsel FDA and Regulatory Law at McKesson Corporation and as outside counsel to a myriad of pharmaceutical and medical device companies while in private practice at Wiley Rein LLP and Shook, Hardy & Bacon LLP, respectively. Prior to her tenure in private practice, she served as Regulatory Counsel at the FDA for close to ten years. There she assisted on a variety of legal and policy issues in the following Centers: the Center for Devices and Radiological Health; the Center for Drug Evaluation and Research; and the Center for Food Safety and Applied Nutrition.

Ms. Gunawardhana received a BA from Syracuse University, a MA from Webster University, an MPH from Boston University, a JD from the University of New Hampshire School of Law and a LLM from Washington College of Law, American University.