EU Regulations and Guidelines in Pharmacovigilance
Venue: Online training
Date: 09 Sep – 10 Sep 2020*
In 2012, new EU pharmacovigilance regulations and guidance became effective in Europe replacing the former Volume 9A rules governing Medicinal Products in the European Union. They describe the structures, requirements, 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. Our EU Regulations and Guidelines for Pharmacovigilance course will cover the development and current requirements of Good Pharmacovigilance Practices (GVP). The course will also cover other aspects of the current legislation and will provide delegates with a professional working knowledge of EU Pharmacovigilance requirements and an overview of the processes and procedures necessary to ensure compliance. Consideration will also be given to the effects on pharmacovigilance requirements of the UK leaving the EU.
*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 drug safety, clinical research, medical affairs, medical writing, regulatory, and medical information
- Staff from regulatory authorities
How our courses work
- Taught over two days
- Small class size allows for one-to-one interaction with expert tutors
- A combination of short lectures, practical workshops and interactive discussion sessions
- Taught by a panel of expert speakers (minimum of four speakers per course) from industry, regulatory authorities and academia
- Course materials including presentations, workshop material and suggested reading documents are made available electronically during the course
- The agenda provides ample opportunity to network with expert speakers and your fellow delegates
Lunch, refreshments and all course materials are included in the registration fee.
Aims of course
- To explore the law and guidance defining EU Pharmacovigilance requirements including changes in the July 2012 EU PV legislation and issues associated with their current and future interpretation
- 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
On successful completion of this course delegates should be able to:
- Analyse and explain the expectations and scope of the EU 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
- 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
- Reporting of adverse drug reactions
Registration fee includes 20% discount as this course is now being taught online.
Cost Per Delegate:
£620 + VAT Academic
(Academic Units, Public Sector Organisations, Registered Charities)
£952 + VAT Standard
Download Course Programme
Click here to download the programme
“Great content and brilliant presenters. A great opportunity to network.”
“Very well organised, experienced industry professionals as speakers, excellent venue/location”
“Very interesting and enjoyable course. Would very much recommend.”
“Great speakers who are very qualified in Pharmacovigilance. Each presentation was informative and very well presented. I learnt a lot.”
“Good speakers with excellent knowledge of their subject area. Good anecdotes in the presentations which helped illustrate the points made.”
Dr Glyn Belcher – Owner, PV Consultancy Ltd
Dr Glyn Belcher has over 25 years’ experience in clinical development and drug safety in the pharmaceutical industry Dr Belcher qualified in medicine from Oxford and Cambridge and received his PhD in neuropharmacology from the latter university. After a number of years in hospital medicine he joined Schering and worked in clinical research in the UK affiliate before moving to headquarters in Berlin, first as head of cardiovascular clinical research and later as head of a new safety department covering clinical development activities. Dr Belcher then became Director of Clinical Drug Safety and EU QPPV for Takeda Europe and a global safety officer of Takeda headquarters in Osaka. His most recent position in the industry was Vice President of Drug Safety and Risk Management for all ex-USA territories of Biogen Idec and EU QPPV for the company. Dr Belcher now has his own consultancy company. PV Consultancy Ltd, and works with a number of companies in the areas of clinical development and drug safety, as well as undertaking an increasing commitment to teaching and training in these areas.