Introduction

The biotech and pharmaceutical industries are among the most regulated sectors, facing stringent compliance requirements related to drug development, clinical trials, manufacturing, marketing, and distribution. With global regulations tightening, companies must navigate Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), FDA, EMA, and other regulatory bodies’ requirements to ensure safety, efficacy, and compliance in all aspects of their operations. This course provides a deep dive into compliance challenges and risk management strategies for biotech and pharmaceutical professionals.

Objectives

By the end of this course, participants will:

1. Understand key global regulatory frameworks (FDA, EMA, MHRA, ICH, WHO, CFDA, etc.).
2. Learn compliance best practices in drug development, clinical trials, and manufacturing.
3. Identify fraud, misconduct, and ethical issues in biotech and pharma compliance.
4. Explore the impact of AI, big data, and digital transformation on regulatory compliance.
5. Gain expertise in marketing, advertising, and promotional compliance (off-label promotion risks, transparency, and fair marketing).
6. Develop strategies for compliance auditing, monitoring, and risk management in biotech and pharma companies.

Who Should Attend?

This course is ideal for professionals in biotech, pharmaceuticals, life sciences, and healthcare compliance, including:

• Regulatory Affairs Professionals
• Compliance Officers and Risk Managers
• Clinical Research and Drug Development Specialists
• Legal Counsels in Biotech and Pharma
• Manufacturing and Quality Assurance (QA) Professionals
• Medical Affairs and Pharmacovigilance Officers
• Sales, Marketing, and Medical Device Compliance Experts
• Biotech and Pharma Executives

Course Outline

Day 1: Global Regulatory Frameworks and Compliance Fundamentals

Session 1: Overview of Global Pharmaceutical and Biotech Regulations

• FDA (U.S.), EMA (EU), MHRA (UK), WHO, CFDA (China), PMDA (Japan).
• ICH Guidelines (GxP: GMP, GCP, GLP, GDP, GVP) – what they mean for compliance.
• Regulatory trends and future outlook in biotech and pharma.

Session 2: Drug Development and Compliance in Clinical Trials

• Good Clinical Practice (GCP) and trial integrity.
• Ensuring compliance in informed consent, patient rights, and data integrity.
• Decentralized clinical trials (DCTs) – regulatory challenges in virtual studies.

Session 3: Hands-on Lab 1 – Clinical Trial Risk Assessment

• Participants assess compliance risks in a real-world clinical trial case study.

Day 2: Manufacturing Compliance, Quality, and Risk Management

Session 1: Good Manufacturing Practices (GMP) Compliance

• EU and U.S. GMP standards for biotech and pharma companies.
• Data integrity and electronic records compliance (FDA 21 CFR Part 11, EU Annex 11).
• Supply chain compliance and Good Distribution Practices (GDP).

Session 2: Pharmacovigilance and Drug Safety Regulations

• Adverse Event Reporting (AER), safety monitoring, and risk management.
• ICH E2E guidelines on pharmacovigilance and post-marketing surveillance.
• AI-driven drug safety monitoring and challenges in automated compliance.

Session 3: Hands-on Lab 2 – GMP Audit Simulation

• Participants review a pharmaceutical manufacturing facility’s compliance status.

Day 3: Marketing, Promotion, and Ethical Compliance in Pharma

Session 1: Marketing Compliance and Off-Label Promotion Risks

• FDA, EMA, and global regulations on pharmaceutical advertising.
• Off-label marketing risks and False Claims Act violations.
• Case studies of pharmaceutical companies fined for compliance breaches.

Session 2: Transparency and Anti-Corruption Regulations (FCPA, UK Bribery Act, Sunshine Act)

• Global anti-corruption laws and their impact on pharma compliance.
• Sunshine Act and transparency in physician payments.
• Best practices for third-party risk management and HCP (Healthcare Professionals) interactions.

Session 3: Hands-on Lab 3 – Developing a Compliant Marketing Campaign

• Participants create a pharmaceutical marketing strategy that meets compliance regulations.

Day 4: Digital Transformation, AI, and Emerging Compliance Challenges

Session 1: AI and Big Data Compliance in Biotech and Pharma

• AI-driven drug discovery and regulatory concerns.
• The role of machine learning in compliance monitoring and risk assessment.
• Digital health compliance (telemedicine, AI-based diagnostics, wearable tech, and mobile health apps).

Session 2: Cybersecurity, Data Protection, and GDPR in Pharma

• HIPAA, GDPR, and data privacy regulations in life sciences.
• Cybersecurity threats to biotech and pharma firms (data breaches, ransomware).
• Blockchain in regulatory compliance and secure data sharing.

Session 3: Hands-on Lab 4 – AI & Data Compliance Risk Assessment

• Participants evaluate a biotech firm’s AI-driven drug research compliance strategy.

Day 5: Future Compliance Trends, Risk Management, and Auditing

Session 1: Future Regulatory Trends in Biotech and Pharma Compliance

• Gene therapy, personalized medicine, and compliance risks.
• Regulatory oversight of mRNA vaccines and cell/gene therapy.
• Ethical concerns in genetic modification and AI-driven research.

Session 2: Building a Robust Compliance Program and Risk-Based Auditing

• Developing an internal compliance monitoring system.
• Conducting effective compliance audits and investigations.
• Crisis management strategies for regulatory inspections and non-compliance issues.

Session 3: Hands-on Lab 5 – Compliance Risk Mitigation Strategy Workshop

• Participants design a risk mitigation plan for a biotech/pharma company.

Conclusion and Certification

• Final discussion on compliance challenges and regulatory changes.
• Participants receive a Certificate in Biotech and Pharma Compliance.