Introduction

Pharmaceutical procurement is a highly regulated and ethically sensitive sector where compliance with global and national regulations, contract management, and risk mitigation is essential. With increasing scrutiny on supply chain transparency, drug pricing, intellectual property rights, and regulatory compliance, procurement professionals must navigate complex legal frameworks and evolving industry standards to ensure the safe, efficient, and ethical acquisition of pharmaceutical products.

This course provides a strategic and practical approach to pharmaceutical procurement, covering key areas such as legal frameworks, contract negotiation, compliance with Good Procurement Practices (GPP), anti-corruption laws, risk management, and sustainable procurement.

Course Objectives

By the end of this course, participants will be able to:

• Understand global and national pharmaceutical procurement regulations.
• Navigate compliance challenges, including FDA, EMA, WHO, and GMP requirements.
• Implement best practices in contract management and supplier selection.
• Mitigate risks related to counterfeit drugs, supplier fraud, and pricing manipulation.
• Ensure ethical and transparent procurement practices while preventing corruption.
• Address emerging trends such as digital procurement, AI in supply chain management, and sustainability in pharmaceutical sourcing.

Who Should Attend?

This course is ideal for professionals involved in pharmaceutical procurement, legal compliance, and supply chain management, including:

• Pharmaceutical Procurement Specialists
• Regulatory Compliance Officers
• Supply Chain & Logistics Managers in Healthcare & Pharma
• Legal Advisors & Contract Managers in Pharmaceuticals
• Government Health Procurement Officers
• Medical & Hospital Procurement Managers
• NGOs & International Health Organizations (WHO, UNICEF, Global Fund, etc.)

5-Day Course Outline

Day 1: Legal & Regulatory Frameworks in Pharmaceutical Procurement

• Global & National Pharmaceutical Procurement Regulations
  • WHO guidelines on Good Procurement Practices (GPP).
  • Regulatory authorities (FDA, EMA, MHRA, SFDA, etc.).
  • Public vs. private sector procurement laws and frameworks.
• Intellectual Property (IP) & Patents in Pharmaceutical Procurement
  • Understanding TRIPS (Trade-Related Aspects of Intellectual Property Rights).
  • Generic vs. branded drug procurement legal considerations.
• Licensing & Import/Export Compliance
  • Navigating import restrictions and customs regulations.
  • Compliance with Good Distribution Practices (GDP).
• Workshop: Analyzing a regulatory compliance checklist for pharmaceutical procurement.

Day 2: Supplier Selection, Contract Management & Pricing Regulations

• Pharmaceutical Supplier Due Diligence & Risk Assessment
  • Evaluating supplier credibility, GMP compliance, and quality assurance.
  • Preventing supply chain disruptions and counterfeit drugs.
• Contracting in Pharmaceutical Procurement
  • Drafting and negotiating procurement contracts (fixed-price, cost-plus, framework agreements).
  • Key legal clauses: liability, indemnity, warranties, and force majeure.
• Drug Pricing Regulations & Government Price Controls
  • Reference pricing, price caps, and reimbursement policies.
  • Legal issues in price negotiations with pharmaceutical companies.
• Case Study: Reviewing a pharmaceutical procurement contract for compliance risks.

Day 3: Risk Management, Anti-Corruption Laws & Ethical Procurement

• Pharmaceutical Procurement Risk Management
  • Identifying risks: supplier fraud, quality failures, regulatory non-compliance.
  • Mitigating risks through due diligence, audits, and monitoring.
• Anti-Bribery & Corruption Laws in Pharmaceutical Procurement
  • Compliance with FCPA (Foreign Corrupt Practices Act), UK Bribery Act, and national anti-corruption laws.
  • Ethical challenges in pharmaceutical procurement and lobbying.
• Transparency & Accountability in Drug Procurement
  • Preventing bid-rigging, collusion, and kickbacks.
  • Role of NGOs and government watchdogs in ensuring fair procurement.
• Workshop: Developing a pharmaceutical procurement ethics and compliance policy.

Day 4: Digital Transformation & AI in Pharmaceutical Procurement

• E-Procurement & Digital Supply Chain Management
  • Role of e-procurement platforms in ensuring transparency and efficiency.
  • Challenges in digitizing pharmaceutical procurement.
• AI, Blockchain & Big Data in Pharmaceutical Procurement
  • AI-driven forecasting and supplier performance evaluation.
  • Blockchain for drug traceability and counterfeit prevention.
• Cybersecurity & Data Protection in Pharmaceutical Procurement
  • GDPR, HIPAA, and protecting sensitive procurement data.
  • Managing cybersecurity risks in supplier contracts.
• Case Study: Implementation of blockchain for pharmaceutical supply chain security.

Day 5: Sustainable Procurement & Future Trends in Pharmaceutical Sourcing

• Green Procurement & Sustainability in the Pharmaceutical Industry
  • Sustainable sourcing of raw materials and eco-friendly packaging.
  • Regulatory trends in environmental compliance and pharmaceutical waste management.
• Crisis Management & Procurement Resilience
  • Managing procurement during global health crises (pandemics, supply chain disruptions).
  • Emergency procurement strategies and legal exemptions.
• Future of Pharmaceutical Procurement: Trends & Innovations
  • AI-driven procurement, personalized medicine, and decentralized manufacturing.
  • Cross-border regulatory harmonization and public-private partnerships.
• Final Project: Developing a strategic procurement plan for a pharmaceutical organization.