Pharmaceutical and Biotech Contracts: Compliance and Negotiations

Objectives:

• Understand key legal concepts and regulations in pharmaceutical and biotech contracts.
• Gain skills in negotiating terms that balance business and regulatory requirements.
• Learn strategies for ensuring compliance throughout the contract lifecycle.
• Explore best practices for drafting and reviewing contracts in the pharmaceutical and biotech sectors.

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

DATE:
1ST BATCH: 11th – 14th Mar, 2025
2ND BATCH: 24th – 27th June, 2025
3RD BATCH: 21st – 24th Oct, 2025