讲师团队
Carol H. Danielson, DrPH, MS, RAC
President, Regulatory Advantage, LLC, United States
Ms Carol H. Danielson, Dr PH, RAC has provided regulatory expertise and leadership for more than twenty five years for drugs, biologics and medical devices from discovery through post-marketing. Her areas of specialization include regulatory strategy and submissions, clinical affairs and compliance, and quality assurance and control. Her background includes both extensive “hands on” experience and corporate level strategy activities from partnering due diligence to serving as an expert witness in the drug development process.
Kevin Daniel Healy, PhD
Senior Vice President Regulatory Affairs, Entrada Therapeutics, United States
Dr. Kevin Healy is Senior Vice President of Regulatory Affairs at Entrada and is a member of the senior leadership team and responsible for developing and executing global regulatory strategies to advance Entrada’s pipeline. Kevin has extensive expertise in the development and commercialization of therapies for serious and rare diseases and has led or participated in more than 30 formal meetings. Prior to joining Entrada, Kevin oversaw Regulatory Affairs and other biotech-enabling functions, including Quality, Pharmacovigilance, and Compliance, at multiple biotech companies.