Short Course
EU and UK Regulations & Guidelines in Pharmacovigilance (Online)
Venue
Online
Date
17 March 2027 - 18 March 2027
Course overview
EU pharmacovigilance regulations and guidance (Good Pharmacovigilance Practice, GVP) govern the requirements of pharmacovigilance of medicinal products in the European Union. They describe the structures, obligations, procedures, roles and activities of the various stakeholders. These are detailed for the collection, verification, presentation and interpretation of adverse reports to exchange information within the EU, to monitor safety products on the market in the EU, to proactively manage safety concerns and to guarantee continuous surveillance of the benefit risk profile of such drugs.
The EU and UK Regulations and Guidelines for Pharmacovigilance course will cover the development and current requirements of Good Pharmacovigilance Practices. The course will also cover other aspects of the current legislation including new requirements for pharmacovigilance in UK following the end of the Brexit transition period. The course will provide delegates with a professional working knowledge of EU and UK Pharmacovigilance requirements and an overview of the processes and procedures necessary to ensure compliance.
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 drug safety, clinical research, medical affairs, medical writing, regulatory, and medical information
- 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 explore the law and guidance defining EU and UK Pharmacovigilance requirements.
- To analyse the operational aspects of case processing, from receipt to electronic reporting, both for individual cases and the construction of aggregate reports required by regulators
- To review critically, the qualitative aspects of pharmacovigilance system such as quality assurance, audit, compliance, post-authorization safety studies (PASS), signal detection, risk management and communication
- To explore critically, the role of the Qualified Person in Pharmacovigilance (QPPV)
- To analyse the impact of licensing agreements on pharmacovigilance
- To review the role and practice of regulatory inspections of pharmacovigilance systems
Learning outcomes
On successful completion of this course delegates should be able to:
- Analyse and explain the expectations and scope of the EU and UK pharmacovigilance system
- Choose, justify and assemble the appropriate tools and manage the processes necessary to facilitate regulatory compliance
- Appraise the role and responsibilities of the QPPV
- Understand the role of the pharmacovigilance inspectorate and how best to prepare for inspections
Programmed features
- Development of Good Pharmacovigilance Practice (GVP)
- Timetable for implementation and requirements of GVP
- Pharmacovigilance System Master Files
- Update of PSURs, Risk Management Plans and PASS
- Inspections
- Reporting of adverse drug reactions
Download programme
17 March 2027 - 18 March 2027
Book now
- 17 March 2027 - 18 March 2027
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.