Pharmaceutical and Biotech Contracts: Compliance and Negotiations

Introduction to Pharmaceutical and Biotech Contracts

• Overview of the pharmaceutical and biotech industries
• Key legal frameworks: FDA regulations, EMA guidelines, and other regulatory bodies
• Types of contracts in the industry (R&D, licensing, supply, collaboration agreements)
• Basic principles of contract law relevant to the sector

Regulatory Compliance in Pharmaceutical and Biotech Contracts

• Understanding compliance requirements for clinical trials and drug development
• The role of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) in contracts
• Privacy and data protection considerations (GDPR, HIPAA)
• Key clauses for ensuring regulatory compliance (e.g., reporting obligations, inspections)

Negotiating Pharmaceutical and Biotech Contracts

• Preparing for contract negotiations: stakeholder mapping and objectives setting
• Common negotiation tactics and strategies in biotech and pharma deals
• Structuring key contract terms: payment terms, milestones, royalties, and liabilities
• Dealing with intellectual property (IP) rights, patents, and confidentiality

Drafting, Reviewing, and Managing Pharmaceutical and Biotech Contracts

• Best practices for drafting clear and enforceable contracts
• Key contract clauses in pharmaceutical and biotech agreements (e.g., indemnification, termination)
• Managing contract performance and compliance post-signing
• Dispute resolution mechanisms and exit strategies

1ST BATCH: Tuesday, February 24, 2026 — Friday, February 27, 2026.

2ND BATCH: Tuesday, June 16, 2026 — Friday, June 19, 2026.

3RD BATCH: Tuesday, October 13, 2026 — Friday, October 16, 2026.

The training methodology integrates lectures, interactive discussions, collaborative group exercises, and
illustrative examples. Participants will acquire a blend of theoretical insights and hands-on practical
experience, emphasizing the application of learned techniques. This approach ensures that attendees return
to their professional environments equipped with both the competence and self-assurance to effectively
implement the acquired skills in their responsibilities.