U.S.Global
Drug Development 101Country SpecificCountry Specific

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


Regulatory Compliance 101: Global Compliance

European Comparator

Course Focus
Provide healthcare communication professionals (within companies, agencies, and consultancies) with an overview of the similarities and differences between regulatory promotional guidelines in the five major European markets: United Kingdom, Italy, Spain, France and Germany. This module also covers the application and implementation of the relevant EU Directives on pharmaceutical promotion, as well as the application of the EFPIA Code to a particular EU member state.

There are minor differences in pharmaceutical promotion in each EU member state because each member state interprets the Directives and the EFPIA Code in its own way. This is reflected in their local laws and codes.

The first half of the course (regulatory environment, pre-vetting, certification, content do’s and don’ts) applies to all countries because the guidelines impact any professional promoting a drug.  The second half of the course enables participants to research the specific countries and tactics most relevant to their needs.

Course Format and Access

  • 24/7 on-demand access from CCC Web site; may be viewed as often as desired
  • Length of Module is 40 minutes

Course Content

  • Regulatory Authorities similar to US FDA
  • Self-Regulatory Industry Associations and Codes
  • How To Apply Different Codes
  • If a company is promoting in its own country
  • If a non-European company is promoting in a European country
  • If a European company is promoting in another European country 
  • If local HCPs are participating
  • If there is a conflict between codes of different countries
  • Pre-Vetting of Promotional Materials
  • Certification
  • Content Do’s and Don’ts
  • Use of Word "New"
  • Referencing Unlicensed Product or Indication
  • Superlatives
  • Comparisons
  • Use of Competitor’s Name
  • Artwork
  • Reprints
  • Teaser and Abbreviated (reminder) ads
  • Professional and Consumer Websites
  • Non-promotional Activities
  • Disease Awareness
  • Patient Group Communications
  • Communications with HCPs
  • Exhibits
  • Gifts
  • Payments to Consultants
  • Meetings and Hospitality
  • Public Relations

Certification Test

Regulatory Compliance Test (RCT) Certification

  • 40 questions
  • Combination of true/false and multiple choice questions