Understanding PhV today – a training course for those working on drug safety monitoring in the EU, USA and Japan
This course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance. The course will cover regulatory requirements and obligations and will include practical workshop sessions.
Key topics to be addressed at this pharmacovigilance conference
This course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance. In addition, detailed information will be provided on regulatory developments in pharmacovigilance in Europe, the USA, and Japan.
This three-day introductory course is aimed at personnel in research and development departments, adverse reaction monitoring units, regulatory affairs and registration departments; pharmaceutical physicians and drug safety officers. It will also be of direct benefit to all those who are involved and interested in the daily practice of pharmacovigilance.
09.00 Registration and coffee
09.30 Principles of Pharmacovigilance and Data Resources
Risk Management and Risk Minimisation: Basic Principles
Causality Assessment: Clinical Diagnosis of Adverse Events
The Current Regulatory Framework and its Global Impact
European Post-Marketing Pharmacovigilance Regulations
Overview of requirements which will include:
17.15 End of Day One and Drinks Reception
09.30 Pro-Active Pharmacovigilance Pre-and Post Marketing
Clinical: Trial ADR Reporting Requirements
Pharmacoepidemiology Studies – Basic Designs, Strenghts, Weaknesses and Examples
Where are We Now with PSURs (or PBRERs)
17.00 Close of day two
09.30 Drug Surveillance in Countries Outside Europe
Practicalities of Signal Detection
Examples of Pharmacoepidemiological Studies Used in Risk Management
Practicalities of Risk Management
A real world example of the development of a successful EU risk management plan
Practical Pharmacovigilance Workshop
As requested by previous participants in this course, this session will comprise a practical case study with valuable hands-on experience covering:
16.00 Close of day three
Carol Markwell (3-5 Dec 2018, 24-26 Jun 2019)
Carol Markwell is Principal Consultant at Director Drug Safety Solutions Ltd a consultancy providing assistance and Pharmacovigilance solutions to Pharmaceutical companies large and small across Europe: process review and optimisation; specification, implementation and validation of global safety databases; pharmacovigilance training, and interim management. She has worked in Pharmacovigilance since 1988, being one of the first to gain the Postgraduate Diploma in Pharmacovigilance from the University of Hertfordshire. In industry she managed a team responsible for international case management UK/ Eire submissions and the preparation of up to 25 PSURs annually.
John Parkinson (3-5 Dec 2018, 24-26 Jun 2019)
John Parkinson is a Data and Pharmaco-epidemiology Consultant having recently retired as the Director of the Clinical Practice Research Datalink (CPRD) at the MHRA. CPRD is the English NHS data and interventional research service. CPRD developed out of the GPRD and the NIHR Research Capability Programme. The CPRD provides data and research services around Drug safety/outcomes and risk-benefit. He joined the Medicines & Healthcare Products Regulatory Agency (MHRA) in September 2005 to run the GPRD (General Practice Research Database). He gained his PhD in Medical Biochemistry in 1972 and joined the Pharmaceutical Industry that year. From 1972 to 1996 he has worked in the Industry or as a Consultant and from 1989 in conjunction with the University of Dundee. In 1996 he moved from working on Medical Education Projects to work at MEMO, a Pharmacoepidemiology Research group, at the University. He has been instrumental in enabling record linkage of NHS data and of its wide use in the many aspects of pharmacoepidemiology as well as providing input to the pharmaceutical industry on studies and types of studies that companies may find helpful in their quest to make available effective and safe medicines. John is a Fellow of the Royal Society of Medicine as well as a Livery member of the Worshipful Society of Apothecaries of London
John Talbot (3-5 Dec 2018, 24-26 Jun 2019)
Dr John Talbot BPharm, MSc,PhD is Senior Lecturer, Pharmacovigilance within the School of Life Sciences at the University of Hertfordshire. Until mid-2011 he was Director Patient Safety, Processes & Standards based at AstraZeneca R&D Charnwood in Loughborough UK. He had been with AstraZeneca (and formerly Astra) since 1996 initially leading the Drug Safety function at one of its R&D sites and later having a global role encompassing Patient Safety processes and standards across the organisation. Before joining Astra, John was Head of the Spontaneous Reports Group, International Product Safety and Pharmacovigilance at GlaxoWellcome having worked with both investigational and marketed products over the past 15 years at Glaxo. Before joining the pharmaceutical industry, he was a hospital pharmacist at a number of UK teaching hospitals and held a joint appointment at the Department of Therapeutics in the University of Birmingham Medical School and the Queen Elizabeth Hospital where he did his PhD on adverse drug reaction monitoring.
He has written papers and book chapters on various aspects of drug safety. He is co-editor with Jeff Aronson of Stephens’ Detection and Evaluation of Adverse Drug Reactions 6th edition published by Wiley Blackwell in early 2012. Over the past 25 years, he has made many presentations at universities and international symposia on several drug safety topics and helped create the postgraduate course in Pharmacovigilance at the University of Hertfordshire.
Glyn Belcher (3-5 Dec 2018, 24-26 Jun 2019)
Dr Glyn Belcher has over 25 years experience in clinical development and drug safety in the pharmaceutical industry. He 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. He 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. He 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.
William Richardson (3-5 Dec 2018, 24-26 Jun 2019)
Bill Richardson qualified in medicine in 1980, and subsequently trained as an anaesthetist. He took up his first post in the pharmaceutical industry as a Medical Adviser in 1987. The next 15 years were spent in the industry in Medical Affairs, Clinical Development, and Pharmacovigilance. He joined the Medicines Control Agency (now MHRA) in 2002 and had responsibility for monitoring the safety of “black triangle” products; signal generation and assessment; pharmacovigilance assessment for CHM, PRAC and CHMP; assessment of licence variations; assessment of Periodic Safety Update Reports and Risk Management Plans; and assessment of advertising. He left the MHRA in 2014 to become a pharmacovigilance consultant for NDA Group.
Ian Douglas (3-5 Dec 2018, 24-26 Jun 2019)
Dr Ian Douglas is an epidemiologist, currently funded by an MRC Methodology Fellowship. He initially studied physiology and completed a PhD in Manchester. Since then he has spent several years at the UK Medicines & Healthcare Products Regulatory Agency and in the pharmaceutcial industry investigating adverse effects of drugs – both in clinical trials and post-marketing. He completed the MSc in epidemiology at LSHTM in 2005. He is the course organiser for the LSHTM Certificate Course in Pharmacoepidemiology and Pharmacovigilance.
His research interests are primarily in pharmacoepidemiology, and in particular, how we can use large primary care databases to investigate the effects of drugs – both harmful and beneficial. He is exploring methodologies to minimise some of the biases inherent in the research of drug effects, and main current areas of interest are case-only approaches to study design and the use of propensity scores. He is also a member of the UK Medicines and Healthcare Products Regulatory Agency’s Pharmacovigilance Expert Advisory Group.
Seema Jaitly (3-5 Dec 2018)
Dr Seema Jaitly qualified in Medicine from Charing Cross and Westminster Medical School in 1992 and worked in hospital medicine for four years. She has worked in the pharma industry for over 18 years at CROs and companies spanning clinical research, medical affairs, pharmacovigilance and the EU QPPV role. In 2010 she founded Essjay Solutions to offer pharmacovigilance services, consultancy and contracting services.
She is currently studying for an MSc in epidemiology with the London School of Hygiene and Tropical Medicine.
|3-5 Dec 2018|
|3-5 Dec 2018||Rembrandt Hotel, London||GBP 1,849.00
+ VAT @ 20.00%
|24-26 Jun 2019|
|24-26 Jun 2019||Rembrandt Hotel, London||GBP 1,849.00
+ VAT @ 20.00%
|2-4 Dec 2019|
|2-4 Dec 2019||Rembrandt Hotel, London||GBP 1,849.00
+ VAT @ 20.00%