EU and UK Regulations & Guidelines in Pharmacovigilance (Hybrid Event)

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.
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 drug safety, clinical research, medical affairs, medical writing, regulatory, and medical information
• 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 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, 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

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

Key topics

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

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

• 13 March 2024 - 14 March 2024

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  UK Based International

  Download course programme