Each CCC Regulatory Compliance Test (RCT) is reviewed by Members of the Advisory Board to ensure that it is comprehensive, practical, and up-to-date. The Board, which is composed of leaders in FDA regulations, government guidelines, and voluntary industry codes, includes former FDA officials and regulatory lawyers in pharmaceutical and medical device companies and from independent consulting and law firms. All CCC Regulatory Compliance Tests have been designed by educational experts. Please note that the Regulatory Compliance Tests are the sole responsibility of CCC itself.
Members of the CCC Advisory Board
Ilyssa Levins, president and founder of the Center for Communication Compliance (CCC) has 30 years of healthcare communications experience, which includes regulatory compliance leadership. Over a period of two decades with Grey Global Group, her entrepreneurial accomplishments included launching the BrandEdge marketing consultancy, catapulting Grey's healthcare public relations (PR) practice to a top 10 global ranking, and leading a PR boutique, GTFH, to be named #1 in healthcare two years in a row.
Early in her career, Ilyssa recognized that regulatory compliance was an under-served area in the healthcare communication profession. In 1991, she founded the PR section of the Coalition for Healthcare Communication, an industry advocacy group focused on FDA regulatory policy and enforcement. However, there continued to be an unmet need for a standardized regulatory compliance curriculum for promotional agencies. Her priority upon leaving the corporate world was to establish a center for learning where regulatory compliance was a key focus. Ilyssa also recognized that industry would be served by a consulting firm that combined the best of regulatory compliance and marketing communications expertise.
To fill this industry need, Ilyssa founded CCC and launched the first standardized training courses, with corresponding certification tests, to enhance regulatory compliance in advertising/promotion, promotional medical education, Internet Promotion/Social Media, patient relationship marketing, and public relations. The company addresses other unmet needs as well: the first pertains to the need for increasing the role of communication professionals in the development and execution of Risk Evaluation and Mitigation Strategy (REMS) components; the second, to the need for a basic course on drug development with a focus on clinical trials for professionals new to the pharmaceutical, biotech, and device industry.
Ilyssa is an industry spokesperson and a published author on regulatory compliance healthcare communication. She was the only healthcare executive to be named a Women Achiever of the Year by the YWCA of New York in 2000, and is a Healthcare Businesswomen's Association (HBA) Rising Star. Her Board memberships include the HBA, where she served as Director of Marketing Communication, Director of Business Development and Strategic Alliances, and Director of HBA Awards. She received the HBA President's Award in 2011 and was named one of the industry's 100 Inspiring People by PharmaVoice in 2012 (see the full article).
Ilyssa graduated Phi Beta Kappa from New York University with a degree in journalism and minors in public relations and Spanish.
Wayne has been published widely on regulatory and crisis management topics. He is the author of the FDA Advertising and Promotion Manual, the standard reference in the field. Wayne has taught graduate-level courses in PR and frequently speaks at educational symposia. He has chaired the annual advertising meetings for both the Drug Information Association and the Food and Drug Law Institute since 1989, and has been given each organization’s highest award. Wayne is a graduate of Rutgers University.
As a member of the industry Social Media Working Group, Preeti met with DDMAC to propose and discuss regulatory guidance for the use of social media in pharmaceutical promotional activities. Under her direction, AstraZeneca was an early adopter of social media in marketing activities. Preeti also led the social media team at AstraZeneca to respond to FDA's Call for Comments regarding regulatory guidance on social media.
Nancie has extensive regulatory affaris experience in managing and auditing Phase I through Phase IV clinical studies both with pharma companies such as Genzyme, and in clinical research settings, such as at the Harvard Medical School, Mass General Hospital, and the Dana Farber Cancer Center. She was formerly the Director of the Oncology Clinical Research Office at the Cancer Research Center of the University of Massachusetts Medical School.
Education and Testing Advisor
Dr. Hoffman has a PhD from Harvard University, where he did advanced academic research and graduate teaching in Instructional Design and Cognitive Psychology. This, combined with his 25 years of business experience, has enabled Dr. Hoffman to apply in business settings the principles of human learning and educational testing. At AT&T and Bell Labs, where the disciplines of mastery testing and competency models were first established in American industry, he worked with the pioneers of educational testing quality control and skill modeling. In the healthcare industry, he has worked with half of the global pharma top 20, including such major organizations as Novartis, Pfizer, Merck, GlaxoSmithKline, Eli Lilly, AstraZeneca, the National Institutes of Health, the National Cancer Institute, and Grey Global Group.