Instructors
Micheline Awad, MBA
Sr. Director, Regulatory Advertising, Promotion, and Labeling, Day One Biopharmaceuticals, United States
Micheline leads the Advertising & Promotion and Labeling functions at Day One Biopharmaceuticals. Her experience includes Regulatory Affairs Strategy, Advertising & Promotion, and Labeling for Biologics, Drugs, and Devices. Her expertise in product launches is driven by strategic planning, risk assessment, and maintaining regulatory compliance while fostering innovation and growth. She is passionate about collaborating with cross-functional partners to drive successful product launches while ensuring adherence to complex regulations and guidances. She received her MBA from University of Southern California with a focus on Strategy and Marketing, and her BS in Biology specializing in Biotechnology from George Mason University.
Dale Cooke, JD, MA
President, Phillycooke Consulting, United States
Dale Cooke is president of PhillyCooke Consulting, which helps prescription product marketers use 21st century technology to provide healthcare information while ensuring compliance with FDA regulations written in the 1960s. Dale is the author of Effective Review & Approval of Digital Promotional Tactics, now in its second edition, which was published by the Food & Drug Law Institute.
Kimberly Belsky, MS
Reg Policy & Intell and AdPromo, Regulatory Affairs, Independent, United States
Kimberly (Kim) Belsky is a seasoned regulatory professional specializing in Regulatory Policy, Intelligence, and Advertising & Promotion (AdPromo). With over 30 years of global experience in the medical product industry, including more than 20 years in regulatory affairs. Her diverse background spans prescription drugs, biologics, over-the-counter products, nutritionals, cosmetics, and medical devices. She also happily co-chairs the DIA AdPromo Working Group within the Regulatory Affairs Community and is actively involved in the Regulatory Affairs Professional Society (RAPS). Kim is passionate about networking, learning, sharing insights and fostering collaboration.
Have an account?