Mintz Member Joanne Hawana and Associate Benjamin Zegarelli will be featured speakers on two sessions at the DIA Advertising and Promotion Regulatory Affairs Conference being held from March 12 – 13 in Washington, DC. Ms. Hawana also served on the program committee for the conference organized by the DIA.
As session chair, Ms. Hawana will lead a panel discussion on Friday, March 13 titled “Engaging with Patients to Diversify Advertising and Promotional Activities.” The session will explore the opportunities and challenges associated with medical product developers’ direct outreach to patients and caregivers, and provide tips for incorporating patient-derived information into promotional activities. Her session’s panelists are Lisa Pieretti, Executive Director and Co-founder of the International Hyperhidrosis Society, Pamela Goldberg, President and CEO of the Medical Device Innovation Consortium, and Minerva Hughes, PhD, Regulatory Counsel of the Office of Clinical Evidence and Analysis, FDA Center for Devices and Radiological Health (CDRH).
Mr. Zegarelli will serve as a session chair for a panel discussion on Thursday, March 12 titled “Mobile Medical Apps vs. Medical Devices.” His panel will provide an overview of mobile medical apps and an analysis of the processes and considerations involved in the promotion and advertising of mobile medical apps as compared to traditional medical devices. Mr. Zegarelli’s panelists are Bakul Patel, Director of Digital Health Division, CDRH, Diane Johnson, Senior Director of the North American Regulatory Affairs Policy and Digital Health, Johnson & Johnson, and M. Jason Brooke, Attorney and Managing Member, Brooke Consulting.
Ms. Hawana counsels global clients on regulatory and distribution-related considerations to bringing a new FDA-regulated product to market. She also advises clients on the business impact of new U.S. federal and state actions that affect those regulated products, such as drugs, foods and medical devices, among others.
Mr. Zegarelli also counsels clients on compliance and regulatory issues, with a focus on FDA regulations. He advises clients in the pharmaceutical, medical device, and biotech industries, and provides counsel on pre- and post-market regulatory strategy, quality system compliance, and clinical trial agreement negotiations.
DIA is a global, member-driven organization mobilizing life sciences and healthcare professionals. View the full conference agenda and additional details here.