Pharmacovigilance in Products Subject to Licensing Agreements

Partnerships between pharmaceutical companies are now commonplace for a range of activities. To ensure that all parties meet their obligations, many agreements need to include pharmacovigilance wording, either as part of contracts or more frequently as separate documents.

The UK and EU Good Pharmacovigilance Practice guidelines outline the expectations placed on Marketing Authorisation Holders (MAHs) to ensure that they fulfil their pharmacovigilance obligations when setting up contractual arrangements with Third Parties.

The Pharmacovigilance in Products Subject to Licensing Agreements course is a balanced mix of presentations and workshops facilitated by speakers with hands on experience in these areas.In order to fulfil these obligations, collaboration is required between partner companies. Detailed pharmacovigilance agreements need to be drawn up, agreed, executed and monitored throughout the relationship.

This module is aimed at providing students with an overview of the nature and types of relationships where pharmacovigilance agreements may be required, what such agreements should contain and how different approaches to meet different types of relationships may be required.

The Pharmacovigilance in Products Subject to Licensing Agreements course is a balanced mix of presentations and workshops facilitated by speakers with experience in these areas.

Who should attend

This course is aimed at:

• Pharmaceutical industry personnel from areas including pharmacovigilance, drug safety, regulatory affairs, clinical research and legal departments

• Staff from regulatory authorities

How our courses work

• Taught over two days

• A combination of lectures and interactive workshops

• Network with other delegates and speakers via scheduled discussion sessions (virtual delegates), and during coffee and lunch breaks (in-person delegates)

• Full access to PDFs of the presentations afterwards

• Use this course as part of your Continuing Professional Development (CPD)

• Refreshments and lunch provided (in-person delegates)

• Virtual delegates will be sent a link in advance to enable you to join the live course at the stated time

Aims of the course

• To review industry best practice in line with the regulatory guidance to meet 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.

Learning outcomes

On successful completion of this course delegates should be able to:

• Describe some types of agreements and relationships and consider the strengths and weaknesses of such approaches in the context of a safety agreements

• Demonstrate a critical awareness of modules for safety agreements and have basic knowledge and skills required to proactively manage the development and execution of a safety agreement with a partner

Key topics

Programmed features:

• Nature and types of relationship

• Due diligence activities

• Content of safety agreements

• Challenges with international sales teams

• Perspective from a small pharmaceutical company

• Managing relationships

• Legal aspects

• Compliance and audit

• Regulatory expectations – an inspector’s perspective