Short Course
Pharmacovigilance in Products Subject to Licensing Agreements (Online)
Venue
Online
Date
4 November 2026 - 5 November 2026
Course overview
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.
Our Pharmacovigilance in Products Subject to Licencing Agreements course provides delegates with more information on the nature and types of relationships and agreements. Sessions will involve practical advice on the drafting, content and management of agreements to help you to ensure your agreements remain compliant.
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.
Please note, the course dates and programme may be subject to change.
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 course works
- Taught over two days online
- A combination of lectures and interactive workshops
- Interact with other delegates and speakers via scheduled discussion sessions
- Full access to PDFs and recordings of the presentations afterwards
- Use this course as part of your Continuing Professional Development (CPD)
- Delegates will be sent a Teams link in advance to enable you to join the live course at the stated time
- Certificate of attendance provided upon completion of the course
Our fees
Registration fees include electronic access to all course materials.
Please note, VAT is only applicable for delegates based in the UK.
Cost Per Delegate:
Academic
£775 + VAT
(Academic Units, Public Sector Organisations, Registered Charities)
Standard
£1190 + VAT
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
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
Download programme
Please download the relevant programme for your chosen course date.
4 November 2026 - 5 November 2026
Book now
- 4 November 2026 - 5 November 2026
Limited places available - register early to secure your spot
Our courses are CPD accredited by the Faculty of Pharmaceutical Medicine and are recognised by PharmaTrain.