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Healthcare & Pharma 30m

Pharmaceutical Ethics and Regulatory Compliance

This course provides pharmaceutical and life sciences professionals with a structured understanding of ethical, compliance, and data privacy requirements in the pharma industry.

Pharmaceutical Ethics and Regulatory Compliance

What this course covers

  • Core ethical principles and industry standards (e.g., codes of conduct, industry codes).
  • Key regulatory frameworks governing promotion and interactions with healthcare professionals (HCPs).
  • Anti-bribery and anti-corruption expectations in pharma.[cite:207][cite:213]
  • Data privacy and protection (e.g., GDPR, patient data handling) in a pharma context.
  • Practical application through real-world scenarios.

Modules

Module 1: Ethical Principles and Industry Standards in Pharma

Introduces core ethical principles and industry standards that govern pharma business conduct, including honesty, transparency, patient safety, and fairness.

Module 2: Industry Codes, Legal Requirements, and Transparency

Explores how industry codes and legal requirements shape pharmaceutical practices, including transparency obligations and reporting of transfers of value to HCPs.

Module 3: Interactions with Healthcare Professionals and Institutions

Focuses on rules and best practices governing interactions with HCPs and institutions: meetings, sponsorships, educational events, and provision of information.[cite:207]

Module 4: Promotional Compliance and Off-Label Risk

Examines promotional practices, off-label promotion risks, and rules governing marketing and communication about pharmaceutical products.

Module 5: Anti-Bribery and Anti-Corruption Requirements

Explores anti-bribery and anti-corruption expectations in pharma, including interactions with public officials, procurement processes, and third-party relationships.

Module 6: Data Privacy and Patient Data Protection

Addresses data privacy and protection in a pharmaceutical context: handling patient data, research data, and cross-border data transfers.[cite:207][cite:213]

Module 7: Documentation, Recordkeeping, and Audit Readiness

Explores documentation and recordkeeping practices that support compliance: how to maintain evidence of ethical, compliant behavior and prepare for audits and inspections.

Module 8: Applying Ethics and Compliance in Daily Decision-Making

Synthesizes ethics and regulatory requirements into daily decision-making frameworks and practical scenarios.

Course features

SCORM 1.2 or 2004 Audio Narration Captions Transcript Knowledge Checks Locked Navigation Post-Assessment Certificate
Frequently asked questions

Who should take Pharmaceutical Ethics and Regulatory Compliance?

This course provides pharmaceutical and life sciences professionals with a structured understanding of ethical, compliance, and data privacy requirements in the pharma industry.

How long does the course take?

About 30 minutes, delivered across 8 modules with knowledge checks.

What does the course cover?

Core ethical principles and industry standards (e.g., codes of conduct, industry codes); Key regulatory frameworks governing promotion and interactions with healthcare professionals (HCPs); Anti-bribery and anti-corruption expectations in pharma.[cite:207][cite:213]; Data privacy and protection (e.g., GDPR, patient data handling) in a pharma context; Practical application through real-world scenarios.

Do learners receive a certificate?

Yes. The course issues a certificate on completion. It ships SCORM 1.2 or 2004 with audio narration, captions, transcript, and runs on the Provisant learning platform.

How much does it cost?

$5 per user per course per year. Annual billing saves 20%. Any course in the catalog can be added to a plan.