Back to Basics in Pharmacovigilance (February)
Venue: Solent Hotel, Whiteley, Fareham
Date: 26 Feb – 27 Feb 2020
Back to Basics in Pharmacovigilance is a course designed to provide solid practical foundations for those working in drug safety. This course will benefit staff working in pharmacovigilance departments and will be of interest to a broad range of staff in the pharmaceutical industry and regulatory authorities.
Monitoring drug safety is very important to public health. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. Those working in pharmacovigilance must have a good working knowledge of the principles of drug safety, its regulations and proactive strategies for risk management.
The Back to Basics in Pharmacovigilance course is one of the three DSRU courses which comprise the Drug Safety Surveillance module of the PMST and can be used by pharmaceutical physicians as part of that training if required. This course is also one of the three compulsory units from our PgC/PgD in Pharmacovigilance run in collaboration with the University of Portsmouth. You can find out more about our postgraduate programme in Pharmacovigilance here.
Who should attend?
This course is aimed at:
- Pharmaceutical industry personnel from areas including pharmacovigilance, clinical research, medical affairs, medical writing, regulatory affairs and medical information
- Pharmaceutical physicians completing the Drug Safety Surveillance module of Pharmaceutical Medicine Specialty Training (PMST)
- Staff from regulatory authorities
Please note that the course dates and programme may be subject to change.
The course is recognised by PharmaTrain.
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 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 provide delegates with a historical perspective of pharmacovigilance
- To explore the principles of causality
- To ensure an understanding of basic terminology and provide definitions of key concepts
- To introduce delegates to current key regulatory requirements, both local and international
- To introduce delegates to the concept of benefit risk in pre-marketing development
- To provide an awareness of the evolution of systems of reporting
On successful completion of this course delegates should be able to:
- Critically appraise the founding principles of pharmacovigilance and landmark cases effecting change to recent drug safety issue
- Explain key operational drug safety definitions
- Demonstrate good pharmacovigilance practice and locate key sources of information and documentation
- Critically discuss issues associated with global pharmacovigilance
- Analyse the stages of drug development in terms of drug safety assessment and benefit risk
- Critically explain the strengths and weakness of pharmacovigilance reporting systems
- Identify and predict future challenges in drug safety and pharmacovigilance
- Historical aspects and evolution of drug safety
- Regulatory aspects, including the Clinical Trial Directive and PDUFA III
- International Conferences on Harmonisation
- Collecting and reporting drug safety information
- Pharmacovigilance planning
Cost Per Delegate:
£775 + VAT Academic
(Academic Units, Public Sector Organisations, Registered Charities)
£1190 + VAT Standard
Registration fee includes lunch, refreshments and electronic access to all course materials.
Download Course Programme
Click here to download the programme
“Excellent variety of information and balance of interactive activities and lecture type teaching.”
“Good mix of presentations and interactive sessions. Good mix of topics.”
“Excellent content and presentations. Very well put together. Enjoyed the practical aspects with workshops”
“Good overview, good speakers and good workshops. I particularly like real applicable scenarios. There was a good balance between pre and post authorisation and large company/small company”
“Very enjoyable, informative and thought provoking course. Lovely venue. Excellent presenters. Very well organised and everyone very approachable.”
“Good overall content, good basics to build a knowledge base in PV.”
Back to Basics in Pharmacovigilance Course Leader
Jean Kilgour-Christie – Consultant
Jean Kilgour-Christie holds a Bachelor of Honours degree in Nursing from the University of Wales College of Medicine. Following a clinical nursing career in general/emergency nursing and diabetology obtained a Masters Degree in Clinical Pharmacology from the University of Aberdeen. She has over 25 years experience in Drug Safety/Pharma. Her career started in VAMP research with the GPRD database (now held at the MHRA – CPRD). Following this she spent time at SmithKline Beecham and Eli Lilly building up experience in all areas of PV across clinical trial and post-marketing, gaining experience in many therapeutic areas including anti-invectives, cardiovascular, diabetes, CNS, vaccines, biologics and in particular oncology. She also has experience globally and in particular working with the EMEA region, as Regional Head at Janssen, as well as working closely with Japan and Japanese regulations. She has been Deputy EU QPPV at Takeda for the last 5 years, with one year as Interim QPPV.
Throughout her time in PV she has expertise in and has been involved in the implementation of many new initiatives including PSURs, PBRERs, Risk Management Plans, 2012 Regulations, GVP and most recently the EMA Simplification Changes. She has spent three and a half years on the EFPIA PV Expert Group and has a particular interest and experience in training and development of PV.
Additionally she spent 2 years as European Head of Regulatory Operations at Janssen and as such gained experience in MAA, NDA and other global submissions from the regulatory as well as the PV perspective.