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Course Curriculum Presented by the
Center for Communication Compliance (CCC)


Course Name
Regulatory Compliance 101: Promotional Medical Education

Course Focus
What healthcare communication professionals (inside companies, at agencies, consultants) need to know about regulatory compliance in company-directed promotional medical education.

Audience
Any professional in the pharmaceutical, biotech, or device industry who works with, designs, executes, reviews, or oversees healthcare promotional medical education or communication programs:

Communications

  • Promotional medical education agencies and industry staff (product and corporate)
  • Vendors serving promotional medical education agencies and industry (e.g., medical writers, video producers)

Marketing and Sales

  • Product managers
  • Marketing executives
  • Sales representatives and division leaders

Compliance and Ethics

  • Compliance officers
  • Regulatory and legal professionals
  • Others with compliance oversight

Others

  • Medical/Scientific Affairs professionals
  • Conference/meeting planners
  • Biomedical writers/editors

All levels, from senior management to beginner.

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 promotional medical education materials and programs, including:
  • Speaker's Bureaus
  • Presentations at scientific meetings
  • Contractual arrangements with speakers, consultants, ad board members
  • Publication plans
  • Speakers' fees
  • Slide kits
  • Gifts to physicians
  • Social events and sponsorships
  • Mechanism of action (MOA) and other videos
  • Dissect complex communication scenarios with multiple regulatory factors at play; apply regulatory guidelines to real-world situations.
  • Answer commonly asked questions, such as:
  • Phase III trial data has just become available for a new product under development. What kind of meetings can be held with the experts in the field at this point of drug development?
  • We are retaining nationally known physicians for our Advisory Board. What is considered a fair market fee? Several physicians have physician spouses – can we pay their expenses as well? If they meet once or twice a year at resort locations to discuss the latest product data, research and company plans, is that okay?
  • Just before a scheduled presentation, an expert speaker reads a just-published paper in a major journal about your drug. The data is not consistent with current labeling. Should the speaker be allowed to share the data, given his/her expertise and the fact that the data was published in a top peer-reviewed journal?
  • A company developing a new product wants to hold a social reception during a national medical society meeting. The plan is to invite attending specialists who are potential prescribers. What are the parameters for holding this type of event? Can we be selective in who is invited? Are there limitations on answering questions about a product under development?
  • Our company wants to create "back-up" or "supplemental slides" for use by speakers in response to potential questions about investigational uses for the approved product. How many back-up slides would be appropriate, and what should they include or not include?
  • What guidelines need to be followed in identifying authors for publication plans? Can "ghost writers" or free-lance contract medical writers be part of the writing team? If so, should they be listed/not listed as among the authors?

Note: Course Content is divided into 3 one-hour sessions containing lecture material and a Q&A segment. The sessions correlate to the three sections of the Regulatory Certification Test (RCT) for Promotional Medical Education:

Regulatory Compliance 101 Part I – Addresses Basic RCT-A
Regulatory Compliance 101 Part II – Addresses Basic RCT-B/Advanced RCT
Regulatory Compliance 101 Part III – Addresses both RCT levels through case studies

Course Instructors

Nationally recognized experts on regulatory aspects of healthcare promotional medical education and promotion.

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.

Anthony Iacono

Anthony M. Iacono is president and founder of Access Medical Network, Inc., a company specializing in medical education strategic planning and design. Previously, Tony was Assistant Vice President at Wyeth Pharmaceuticals and served as chair of the firm's Promotional Guidelines Committee. Formerly, Tony was a member of the AMA's Working Group on Gifts to Physicians from Industry, and education chair and board member of the Healthcare Marketing Council.

CCC's Regulatory Compliance Test (RCT)

CCC certifies regulatory competency in Promotional Medical Education at two levels: Basic and Advanced.