Course Curriculum Presented by the
Center for Communication Compliance (CCC)
Regulatory Compliance 101: Global Compliance
Global Compliance coursework includes three modules:
- Module 1: Application/Dossier Submission and Approval
- Module 1 Expanded: Approval of Promotional Materials by Regulatory Authorities
- Module 2: Global Promotional Compliance
Module 1: Application/Dossier Submission and Approval
Course Focus
What healthcare communication professionals (inside companies, at agencies, consultants) need to know about application/dossier submission and approval for new drugs/devices in the country(ies) addressed. [See list of countries]
Course Format and Access
- 24/7 on-demand access from CCC Web site; may be viewed as often as desired
- Length of Module 1 varies by country
Module 1 Content
- Name of regulatory agencies
- Submission
- Approval
- Brief overview of steps in the Submission and Approval process
- Drugs
- Biologics
- Devices
- Drugs within Devices
- Typical timeframe for review/approval after submission
- Role of Advisory Committees
- Typical format (e.g., electronic, paper, both)
- Special circumstances
- Fast track
- Accelerated approval
- Priority review
- Exclusivity
- Pediatric data
- Expanded access
- Role of cost-effectiveness data
- Decision letters – typical format and content
- Prescribing Information (PI) – content overview
- Role of cost-effectiveness data
Questions Addressed by Module 1
- What is the name of the regulatory agency for products in your country?
- What is the process for approval of investigational products? Is this different for drugs vs. biologics vs. devices, and if so, how? What if a product is a drug within a device?
- Are applications/dossiers submitted electronically or in paper form (or both)?
- What is a typical timeframe between application/dossier submission and approval? What are the key intermediate steps between submission and approval?
- Are advisory committees ever held prior to approval, and if so, in what situations?
- Are there fast track/accelerated approval/priority review opportunities, and if so, in what situations? What are the criteria a product must meet to qualify for these? How does this impact, if at all, review timelines?
- Are there different types of "decision letters" issued by the regulatory agency?
- What are the regulations related to pediatric products and pediatric data? Does pediatric data ever allow for exclusivity provisions or any other benefits? Must pediatric data be obtained prior to initial approval, or can it be obtained after approval? If after approval, in what timeframe must this data be obtained?
- Are there other types of exclusivity that may be granted, and if so, what types?
- What role, if any, does cost-effectiveness data play? Is this ever required in an application/dossier?
- What is the term for "Prescribing Information" (PI) or "labeling" in your country? What are the specific items that must be included in the Prescribing Information?
Expanded Course Content Module for Module 1: Approval of Promotional Materials by Regulatory Authorities
Course Focus
What healthcare communication professionals (inside companies, at agencies, consultants) need to know about the review and approval of promotional materials by regulatory authorities in the country(ies) addressed. [See list of countries]
Course Format and Access
- 24/7 on-demand access from CCC Web site; may be viewed as often as desired
- Length of Expanded Module 1 varies by country
Expanded Module 1 Content
- Brief overview of steps in the process for submission and review
- Meaningful differences for these types of products:
- Drugs
- Plus, special circumstances: black box, accelerated review
- Biologics
- Devices
- Drugs within devices
- Submission requirements for different types of promotional materials (general)
- Sales materials
- Professional advertising
- Press releases
- Direct-to-consumer advertising
- Education (company branded versus unbranded)
- Internet/Web sites
- Typical timeframe, when required
Questions Addressed by Expanded Module 1
- Is there an outside agency that reviews promotional material, or is that done by the same regulatory agency that reviews applications/dossiers? If it is a different agency, what is its name?
- What are the key intermediate steps in the process for submission and review?
- Does this differ for drugs vs. biologics vs. devices, and if so, how?
- Does this differ based on the medium, i.e., print vs. television, etc., and if so, how?
- Does your country permit direct-to-consumer advertising? If so, does the submission/review process differ based on whether the promotional material is patient-directed vs. physician-directed, and if so, how?
- Do all promotional materials need to be submitted or only core pieces? How are "core pieces" defined?
- Do all or some promotional materials need to be submitted in advance of actual use, and if so, how much in advance must they be submitted? Are there exceptions, i.e., may some materials be used prior to approval by the agency?
- What is the timeframe for approvals, if required?
Module 2: Global Promotional Compliance
Course Focus
What healthcare communication professionals (inside companies, at agencies, consultants) need to know about promotional regulatory compliance in the countries addressed.
Course Format and Access
- 24/7 on-demand access from CCC Web site; may be viewed as often as desired
- Length of Module 2 varies by country
Module 2 Course Content
- Regulatory Environment
- Regulatory Bodies and Codes
- Violations and Enforcement
- High Profile Cases
- Difference Between Promotion and Non-Promotion
- Promotion
- Definition
- Pre-Clearance/Certification
- Do's and Don'ts
- General Content
- Use of Word "New"
- Statistical Information
- Comparator Promotion
- Quotations
- Artwork
- Distribution
- Reprints
- Handling Unsolicited Requests
- Dealing with Healthcare Professionals
- Context
- Free Samples
- Gifts
- Consultancy Arrangements
- Meetings: Organization, Hospitality
- Educational Grants
- Off-Label Promotion/Scientific Discussion
- Public Relations: Trade, Consumer, Events
- Internet
- Communications with Patients
- Disease Awareness
- Meetings
- Distribution of Information
- A Note on Devices
- Compliance Programs and Training
Note: For EU Countries
This module 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, and this is reflected in their local laws and codes.
Questions Addressed by Module 2
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 is advertising and promotion defined?
- If authorities consider that an advertisement issued by the company is in breach of the law and/or code, can they stop publication? 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? Can you provide examples of enforcement actions taken against pharmaceutical companies? Does the competition typically initiate the investigations by calling the government authority? How do authorities find out about a failure to comply with a rule for an advertisement, for example?
- What sort of whistleblower laws there are, if any, in your country?
- How do these requirements differ from what companies do internally?
Sales Representatives
- Are there regulations or guidelines regarding interactions between industry representatives and healthcare professionals? If so, what are they, and who establishes them?
Execution and Use of Promotional Materials: What are the key do's and don'ts for product promotion/regulations covering…
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 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? What about press releases for the media – what are the limitations?
- Are there any specific regulations that are important to note regarding off-label usage of a drug/biologic/device?
- Can cost-effectiveness data be included in promotional materials? If so, are there any restrictions?
Educational Pieces
- Does this differ based on whether it is patient-directed vs. physician-directed, and if so, how?
- Are there specific regulations depending on whether the educational pieces are branded vs. unbranded?
Reprints
- What are the regulations, if any, regarding the distribution/use of reprints by industry representatives?
Promotional Booths
- What are the regulations, if any, regarding promotional booths at medical conferences (physical booth set-up, messaging, types of promotional pieces allowed, reprints allowed or not, premium giveaways allowed or not, staffing by industry representatives, presence of a medical information specialist, etc.)?
Fair Balance
- Are there specific regulations regarding the appearance of promotional materials, for example: font size, formatting of words/messages, use of artwork, message placement, etc.?
- Is "fair balance" required, and if so, what does that mean in your country?
Advertising
- What data can and cannot be included in an advertisement?
- What about comparative advertising? Can you talk about another product if there hasn't been a head-to-head trial? What if there has been?
- Are there regulations regarding "reminder ads" and, if so, what are they? Any regarding "coming soon" ads?
- What are the regulations, if any, regarding drugs/biologics with black box warnings?
- Are there regulations in place yet regarding use of digital media for advertising, and if so, what are they?
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? Does this differ after product approval versus for a just-launched/marketed drug?
- Can companies pay for reporters to attend press events?
- Can you use Video news releases (VNRs), background footage (known as 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.?
Internet
- How is Internet advertising regulated? What are the rules? Do they depend on the specific type of Internet activity the company employs (e.g., patient chat rooms, employee blogs)?
- Can promotional company-sponsored websites link to content from an independent site that might have out-of-label data?
- What information can, or must, the company put on a Web site for physicians? For patients?
Certification Tests - Module 2
Regulatory Compliance Test (RCT) Certification
- Available as a combination of five countries, divided by region (e.g., Western Europe)
- Fifty (50) questions per Certification Test (10 questions per country)
- Combination of True/False and multiple choice questions
Additional Customized Consulting
- Social media
- Pricing and Reimbursement
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*Custom Pricing |
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