Introduction

Partnerships between pharmaceutical companies to develop and market products are becoming increasingly common. Due to the stringently regulated environment, all parties subject to licensing agreements need to be fully aware of and compliant with global regulatory reporting requirements. This course provides delegates with an overview of the nature and types of relationships and agreements between such partners. Delegates are equipped with practical advice on how partners should remain compliant with legal requirements. 

Aims

• To review industry best practice in line with regulatory guidance to meet the requirements relating to pharmacovigilance responsibilities in contractual agreements between partners or other third parties

• To provide delegates with practical advice on how to maintain oversight of such agreements when they are in place to continually maintain compliance with responsibilities and legal requirements

• To explore the nature, content and maintenance (including audit) of safety agreements between licensing partners

Programme features

• Nature and types of relationships
• Due diligence activities
• Content of safety agreements
• Challenges with international sales teams
• Perspectives from a small pharma company
• Managing relationships
• Legal aspects
• Compliance and audit
• Regulatory expectations - an inspector's perspective

• Describe some types of agreements and relationships and consider the strengths and weaknesses of such approaches in the context of a safety agreement
• Demonstrate a critical awareness of models for safety agreements and have basic knowledge and skills required to proactively manage the development and execution of a safety agreement with a partner