Course Curriculum Presented by the
Center for Communication Compliance (CCC)
Regulatory Compliance 101: Global Compliance
Individual Countries
Course Focus
Provide healthcare communication professionals within companies, agencies, and consultancies the latest information covering promotional regulatory compliance in the countries listed below.
Course Format and Access
- 24/7 on-demand access from CCC Web site; may be viewed as often as desired
- Length of Module varies by country, but generally are 60 minutes
Course Content
Regulatory Environment
- Bodies, Codes, Laws, Regulations
- Violations and Enforcement
Promotion
- Definition
- Pre-vetting/certification
- Do's and Don'ts
- General Content
- Use of Word "New"
- Comparisons
- Quotations
- Artwork
- Distribution
- Reprints
- Unsolicited Requests
Public Relations
- Press Releases/Press Packs
- Professional and Consumer Media Relations
- Press Conferences
- Payments to Journalists/Spokespeople
- Video Footage
Websites
- Healthcare Practitioners (HCPs)
- General Public
Non-Promotional Activity
- Definition
- Continuing Medical Education (CME)
- Grants
- Patient Communications
- Third-Party Organizations
Communicating with HCPs
- Sampling
- Gifts
- Meetings
- Hospitality
- Educational Grants
- Off-label Information
- Consultancy
Compliance and Training
Topics and Questions Addressed by Module
Code of Conduct/Regulatory Agencies That Monitor Promotional Compliance/Penalties
- What laws and codes of practice govern the advertising of medicinal products in your country? Which government/regulatory agencies oversee company compliance?
- How are advertising and promotion defined?
- If authorities consider that an advertisement issued by a company is in breach of the law and/or code, can they stop publication of the ad? Insist on a corrective statement? What is a company's right of appeal?
- What are the penalties for failing to comply with these rules? Who is responsible for enforcement and how strict is this enforcement? What are some examples of enforcement actions taken against pharmaceutical companies? Does the competition typically initiate investigations by calling the government authority? How do authorities find out about a failure to comply with rules governing promotion?
- What sort of whistleblower laws there are, if any, in your country?
Execution and Use of Promotional Materials: Key Do's and Don'ts for Product Promotion/Regulations
Data
- To what extent can a company provide information to health professionals about a medicine before the product is authorized? Is there a difference if the physician makes an unsolicited request versus a company’s proactively providing the information? Can information be made available at scientific meetings? If so, what types of information? Can a company sponsor these meetings? What are the guidelines? What about publication of these materials? Can press releases be targeted to the media – what are the limitations?
- Are there any specific regulations regarding off-label usage of a drug/biologic/device?
- Can cost-effectiveness data be included in promotional materials? If so, are there any restrictions?
Fair Balance
- Are there specific regulations regarding the appearance of promotional materials, for example: font size, formatting of words/messages, use of artwork, or message placement?
- Is "fair balance" required, and if so, what does that mean in your country?
Artwork and Graphics
- Are there prohibitions on artwork/graphics that can be used in promotional pieces?
Advertising
- Can you execute comparative advertising without head-to-head trials?
- Are there regulations regarding "reminder ads" and, if so, what are they? Any regarding "coming soon" ads?
- What are the regulations regarding drugs/biologics with black box warnings?
Reprints
- What are the regulations regarding the distribution/use of reprints by industry representatives?
Public Relations and Patient Groups for Promoted Products
- Can press releases with product information be sent to professional media? Consumer media? What are the rules for each of these?
- Can companies pay for reporters to attend press events?
- Can you use video news releases (VNRs), background footage (B-roll)? Can physicians appear in them if the company pays?
- What rules apply to meeting with, and funding, patient support groups, including transparency requirements for grants, etc.?
Websites
- Can promotional company-sponsored websites link to content from an independent site that might have off label data?
- What information can, or must, be put on a website for physicians? For patients?
Certification Tests
Fair Balance
- 20+ questions per country
- Combination of true/false and multiple choice questions
| Countries Currently Available | |
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*Custom Pricing |
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