Course Curriculum Presented by the
Center for Communication Compliance (CCC)
Course Name
Regulatory Compliance 101: Public Relations
Course Focus
What healthcare communication professionals (inside companies, at agencies, consultants) need to know about regulatory compliance in public relations.
Audience
Professionals in the pharmaceutical, biotech, and device industries who work with, design, execute, review, or oversee healthcare public relations or communication programs:
Communications
- Public relations agencies and industry staff (product and corporate)
- Advocacy relations professionals and consultants
- Vendors serving PR agencies and industry (e.g., television, video, and broadcast producers, media trainers)
- Investor relations professionals
Marketing and Sales
- Product managers
- Marketing executives
- Sales representatives and division leaders
Regulatory and Legal
- Compliance officers
- Regulatory and legal professionals
All levels, from beginner to senior management.
Course Format and Access
- 3 one-hour modules: lecture and Q&A
- 24/7 on-demand access from CCC Web site
- May be viewed as often as desired
Course Content
- Understand the rules and guidelines imposed by regulatory agencies, industry associations, and trade groups:
- Food and Drug Administration (FDA)
- Office of the Inspector General (OIG) of the Dept. of HHS
- Department of Justice (DOJ)
- Pharmaceutical Research and Manufacturers of America (PhRMA)
- Accreditation Counsel for Continuing Medical Education (ACCME)
- American Medical Association (AMA)
- Review the risks of not complying with the regulations within the current regulatory/legal environment:
- Fines, Exclusions, Incarceration, Damage to Reputation
- Apply the guidelines, rules, and policies to the development and execution of PR materials and programs, including:
- Press releases, VNRs, and media tours
- Web sites and Webcasts
- Spokespeople and media training
- Dissect complex communication scenarios with multiple regulatory factors at play; apply regulatory guidelines to real-world situations
- Answer commonly asked questions:
- Is a company allowed to issue a press release after an advisory committee meeting, and if so does it have to be submitted to the FDA? Can a company spokesperson speak to the media during a committee meeting?
- My client has a drug approved as an accelerated product. What do I need to know about the promotional aspects?
- I heard the First amendment protects press releases; is this true?
- Does it make a difference that our press releases are intended to convey information only to investors and not to doctors?
- We have a key opinion leader quote that we want to use in our press release and DDMAC says it is misleading and to revise it … but the KOL will not agree to change their quote. What should we do?
Note: Course Content is divided into 3 one-hour sessions containing lecture material and a Q&A segment that correlate to the three sections of the Regulatory Compliance Test (RCT) for Public Relations:
Regulatory Compliance 101: Public Relations Part I– Addresses Bas ic RCT-A
Regulatory Compliance 101: Public Relations Part II – Addresses Basic RCT-B and Advanced RCT
Regulatory Compliance 101: Public Relations Part III– Addresses both RCT levels through case studies
Course Instructors
Nationally recognized experts on regulatory aspects of healthcare advertising and promotion. All formerly with the Food and Drug Administration (FDA).
Wayne Pines
Chair of the CCC Advisory Board. He is a nationally recognized expert on regulatory aspects of healthcare advertising and promotion. Wayne served at the FDA for 10 years as chief of consumer education and information, chief of press relations, and associate commissioner for public affairs.
Michael Misocky
President of Misocky Consulting Group. Former Regulatory Review Officer for the FDA Division of Drug Marketing, Advertising, and Communications (DDMAC); Formerly Assistant VP and Deputy Compliance Officer at ImClone Systems; also worked at Abbott Labs and Bristol-Myers Squibb.
CCC’s Regulatory Compliance Test (RCT) for Public Relations
CCC certifies regulatory competency at two levels: Basic and Advanced. The Regulatory Compliance Test (RCT) for Public Relations is structured in three sections:
Basic RCT-A: Regulations and Policies
Basic RCT-B: PR Materials
Advanced RCT: PR Scenarios