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About

This course is a practical masterclass on the ABPI Code of Practice, focused on real-world application in pharmaceutical sales, marketing, medical affairs, and compliance roles. It explains the purpose, scope, and governance of the Code, including the role of the PMCPA and the relationship between legal requirements and self-regulation. The course provides a clear understanding of what constitutes promotion, key definitions such as health professionals and transfers of value, and the responsibilities of companies and individuals. It also covers critical compliance areas including certification of promotional materials, off-label risks, claims and comparisons, and digital communication. Emphasis is placed on avoiding breaches through accurate, balanced, and substantiated information, along with maintaining transparency, ethical conduct, and audit readiness in all activities.

Course Syllabus

  1. Why the ABPI Code Exists
  2. The Four ABPI Principles
  3. What the Code Actually Covers (Clause 1.1)
  4. Key Definitions You Must Know
  5. Who Must Comply with the ABPI Code?
  6. The Role of the PMCPA
  7. How the PMCPA Complaints Process Works
  8. Sanctions: What Happens When You Breach
  9. Legal Framework vs Self-Regulation
  10. The Regulatory Ecosystem
  11. Training & Certification Requirements
  12. Real-World Consequences of Breach

  1. What Counts as Promotion? (Clause 1.17)
  2. What Does NOT Count as Promotion
  3. Scientific Exchange vs Marketing: Drawing the Line
  4. MSL vs Sales Rep: Knowing the Line in Practice
  5. Off-Label Promotion: The Highest Compliance Risk
  6. Claims & Comparisons: The Accuracy Standard (Clauses 6 & 14)
  7. Danger Words in Promotional Copy
  8. Abbreviated Advertisements: Clause 13 Explained
  9. Clause 5: High Standards & Suitability
  10. Disguised Promotion: Clause 15.6
  11. Digital Material: When Does It Count as Promotion?
  12. Certification: Who Signs Off What? (Clause 8)
  13. Real-World Scenario: The LinkedIn Post
  14. Real-World Scenario: The Congress Symposium
  15. Decision Tool: Is It Promotional?
  16. Common Compliance Mistakes: Marketing Teams
  17. Common Compliance Mistakes: Medical Affairs
  18. Representative Conduct: Clause 17 in Practice

  1. Clause 10: Events, Meetings & Hospitality — Overview
  2. The £75 Subsistence Rule: Clause 10.8 in Practice
  3. Types of Meetings: Compliance Snapshot
  4. HCP Sponsorship & Written Agreement Requirements
  5. Prohibition on Inducements: Clause 19 Explained
  6. Speaker Engagements: Getting It Right
  7. Fair Market Value (FMV): Applying It Correctly
  8. Collaborative Working: Clause 20​
  9. Provision of Samples: Clause 21 Rules​
  10. Non-Interventional Studies: Clause 22 Compliance​
  11. Interactions with HCOs: Donations, Grants & Services​

  1. Clause 28: Annual Disclosure of Transfers of Value
  2. What Is a Transfer of Value? Complete Taxonomy
  3. Disclosure UK: Platform, Process & Timeline
  4. Individual vs. Aggregate Disclosure: Key Distinction
  5. HCP Consent for Disclosure: Getting It Right
  6. ToV Category: Fees for Services (Contracted Services)
  7. ToV Category: Donations, Grants & Sponsorship​
  8. Research & Development ToV: Disclosure Requirements
  9. Clauses 29, 30 & 31: Patient Orgs, Public Contracts, Timings
  10. The Disclosure Lifecycle: End-to-End Process
  11. Common Disclosure Mistakes — and How to Avoid Them
  12. Decision Tool: Is This Transfer of Value Disclosable?
  13. Cross-Border & EFPIA Disclosure: Global Considerations

  1. Clause 26: Digital Materials — The Core Principles
  2. Certified vs. Non-Certified Digital Content
  3. Social Media Compliance: What Pharma Employees Can Post
  4. Adverse Event Reporting from Digital & Social Channels
  5. Digital Material Approval: End-to-End Workflow
  6. Digital Grey Areas: Common Tricky Scenarios
  7. Company Websites: Clause 26 Requirements
  8. Email Marketing to HCPs: Compliance Requirements

  1. How the PMCPA Complaints System Works
  2. PMCPA Rulings & Sanctions: What Can Happen
  3. Types of PMCPA Complaints: Who Can Complain?
  4. Self-Declaration: The Case for Reporting Your Own Breach
  5. Internal Breach Management: What to Do When Things Go Wrong
  6. Root Cause Analysis: Turning Breaches Into Learning

  1. The ABPI Compliance Decision Ladder
  2. Decision Heuristics: Practical Tests for Grey Areas
  3. Grey Area Decision Practice: Apply the Framework
  4. Building Compliance Culture: Beyond the Checklist
  5. Running a Pre-Submission Compliance Review
  6. Your Personal Compliance Action Plan

Our Certified Customers

novartis
NHS
takeda
roche
baxter

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Frequently Asked Questions

This course is a practical masterclass on the ABPI Code of Practice designed for pharmaceutical professionals across sales, marketing, medical affairs, and compliance. It focuses on applying the Code in real-world commercial situations, covering key areas such as promotion, healthcare professional interactions, transparency, and certification requirements. The course explains the role of the PMCPA, the scope of the Code, and its relationship with legal regulations, while emphasising ethical conduct, accurate communication, and compliance in all pharmaceutical activities. Through real-world scenarios, decision tools, and compliance frameworks, it enables learners to confidently apply ABPI standards and avoid common compliance risks in day-to-day operations.

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  • Understanding the purpose, scope, and key principles of the ABPI Code of Practice and its role in ensuring ethical pharmaceutical conduct
  • Identifying what constitutes promotion under the Code and differentiating between promotional and non-promotional activities
  • Applying requirements for certification of promotional materials and understanding the responsibilities of medical signatories and the Responsible Person
  • Recognising off-label promotion risks and ensuring all activities remain within the marketing authorisation
  • Applying standards for accurate, balanced, and substantiatable claims and comparisons in promotional materials
  • Understanding the role of the PMCPA, including complaint handling, rulings, and potential sanctions for breaches
  • Ensuring compliance in digital communications, including emails, websites, webinars, and social media activities
  • Using practical decision tools, compliance checklists, and risk-based approaches to support audit readiness and avoid common compliance mistakes

    • This course is designed for professionals across the pharmaceutical industry who are responsible for applying the ABPI Code of Practice in their daily roles, including:

    • Pharma sales and marketing teams involved in promotional materials, campaigns, and healthcare professional engagement
    • Medical affairs professionals managing scientific exchange and ensuring compliance with non-promotional activities
    • Regulatory and compliance professionals responsible for code adherence, certification, and approval processes
    • Signatories and approvers overseeing promotional material review and compliance standards
    • New joiners and mid-level professionals building foundational knowledge of ABPI Code requirements
    This course is intended for individuals seeking to apply practical compliance principles and ensure ethical, accurate, and audit-ready pharmaceutical activities.

    • Clear understanding of the ABPI Code of Practice and its application in real-world pharmaceutical activities
    • Ability to accurately identify promotional vs non-promotional activities and avoid common compliance risks
    • Practical knowledge of certification requirements and approval processes for promotional materials
    • Improved understanding of off-label risks and how to ensure activities remain within marketing authorisation
    • Enhanced capability to develop accurate, balanced, and substantiatable claims in line with Code requirements
    • Awareness of PMCPA processes, complaint handling, and potential sanctions for Code breaches
    • Confidence in managing compliant digital communication across emails, websites, webinars, and social media
    • Access to practical tools such as decision frameworks, compliance checklists, and risk assessment methods for audit readiness