Pharmacovigilance in Products Subject to Licensing Agreements
Venue: Novotel London West Hotel, Hammersmith, London
Date: 27 Nov – 28 Nov 2019*
Partnerships between pharmaceutical companies (through in-licencing, co-development, co-marketing or co-promotion) 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 at a high level guidance for Marketing Authorisation Holders (MAHs) to ensure fulfilment of pharmacovigilance obligations when entering into contractual arrangements with Third Parties are provided in Volume 9 of the “Rules Governing Medicinal Products in the European Union”.
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 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 that the course dates and programme may be subject to change.
|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
Aims of 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.
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
- 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
Cost Per Delegate:
£775 + VAT Academic
(Academic Units, Public Sector Organisations, Registered Charities)
£1190 + VAT Standard
Download Course Programme
Click here to download the programme
“Unlike any other training, DSRU offer very realistic, hands on information. I would definitely recommend the course, it was very helpful.”
“Wide variety of speakers with a lot of experience in different aspects of agreements. Lots of opportunities to ask questions”
“Interactive, good speakers, broad content. Speakers very willing to answer questions”
“I found the course very enjoyable and informative. All the speakers were very knowledgeable in their areas and very approachable.”
“Excellent course. Level of detail ideal, presenters all very good and opportunities for interaction much appreciated for learning.”
“Very detailed coverage of topic – interesting and relevant presentations. Very well organised.”
“High level of good speakers who delivered the whole course very well.”