Pharmacovigilance in Products Subject to Licensing Agreements (Hybrid Event)

Course Overview

Partnerships between pharmaceutical companies to develop and market products are becoming increasingly common. Due to the stringently regulated environment for pharmacovigilance activities and responsibilities, particularly in Europe, all parties to licensing agreements need to be fully aware of, and compliant with, the pharmacovigilance requirements that are often detailed in separate safety agreements. In the EU, the expectations for Marketing Authorisation Holders (MAHs) to ensure fulfilment of pharmacovigilance obligations when entering into contractual arrangements with Third Parties are provided in EU Good Pharmacovigilance Practice guidelines.

Our Pharmacovigilance in Products Subject to Licencing Agreements course provides delegates with an overview of the nature and types of relationships and agreements between such partners. Delegates will be equipped with practical advice on how partners should remain compliant with legal requirements. In addition, the course will provide an overview of other relationships where safety language may be appropriate in other contracts/agreements and things to consider in documenting such relationships in the Pharmacovigilance System Master File.

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.
The in-person session of this course will only proceed when a minimum number of participants is met. Should this number not be reached, the registered participants will be notified at least three weeks prior to the course.

Our courses are recognised by PharmaTrain.

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

Our fees

Please note, VAT is only applicable for delegates based in the UK.

Cost Per Delegate:

• Academic

  £620 + VAT

  (Academic Units, Public Sector Organisations, Registered Charities) - Virtual

• Academic

  £775 + VAT

  (Academic Units, Public Sector Organisations, Registered Charities) - In-Person

• Standard

  £952 + VAT

  Virtual

• Standard

  £1190 + VAT

  In-Person

Registration fees include electronic access to all course materials. Lunch and refreshments are provided for those attending in-person.

Book now

• 15 November 2023 - 16 November 2023

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  UK Based International

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