Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in Drug safety.

3-5 Dec 2018

& 24-26 Jun 2019 , 2-4 Dec 2019

GBP 1,849
EUR 2,589
USD 2,884

Book now

Course overview

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

  • Principles of pharmacovigilance and data resources
  • Risk management and risk minimisation
  • Causality assessment: Clinical diagnosis of adverse events
  • PASS and PAES studies
  • Regulatory framework
  • European Post-Marketing pharmacovigilance regulations
  • Pharmacoepidemiological studies
  • Evolution of PSURs, PBRERs and DSURs
  • Pro-active pharmacovigilance pre- and post marketing
  • Clinical Trial ADR reporting requirements
  • Risk/Benefit assessment
  • Drug surveillance in countries outside Europe
  • Examples of pharmacoepidemiological studies used in risk management
  • Introduction to signal detection
  • Introduction to risk management plans
  • Practical pharmacovigilance workshop

Why you should attend

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.

Who should attend

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.

Day one

09.00 Registration and coffee

09.30 Principles of Pharmacovigilance and Data Resources

  • Basic principles of monitoring drug safety
  • An overview of methodology
  • Data resources available for monitoring and evaluating drug safety
  • Responding to drug safety signals

Risk Management and Risk Minimisation: Basic Principles

  • Basic principles
  • Proactive strategies
  • Principles of risk minimisation
  • PASS and PAES studies

Causality Assessment: Clinical Diagnosis of Adverse Events

  • The principles of causality assessment with practical examples
  • Medical evaluation of individual reports of adverse events
  • Strategies for follow up

The Current Regulatory Framework and its Global Impact

  • Overview of European regulatory framework, including new EU pharmacovigilance legislation
  • Implications for global environment – the links to ICH and CIOMs recommendations
  • Inspections and penalties for non-compliance
  • Practical applications of definitions

European Post-Marketing Pharmacovigilance Regulations

Overview of requirements which will include:

  • The role of Pharmacovigilance Risk Assessment Committee and SCOPE initiative
  • Quality Management Systems and the
  • Pharmacovigilance System Master File (PSMF)
  • QPPV
  • Expedited Reporting solicited vs spontaneous
  • Periodic reports and Signal Management
  • Risk Management Plans and Risk Minimisation
  • Post Authorisation Safety and Efficacy studies (PASS/PAES)
  • Additional Monitoring
  • Pharmacovigilance Inspections/audit
  • Public Hearings
  • Stakeholder involvement initiatives such as PROTECT, WEB-RADR

17.15 End of Day One and Drinks Reception

Day two

09.30 Pro-Active Pharmacovigilance Pre-and Post Marketing

  • Anticipating drug safety issues in development of small molecules and biologics
  • What specific and non-specific safety monitoring should be done?
  • Handling safety signals in development
  • Differences between pre-marketing studies and post-marketing experience

Risk/Benefit Assessment

  • General principles
  • Quantifying risk
  • Taking action to optimise benefit/risk
  • Monitoring the effectiveness of risk management measures

Clinical: Trial ADR Reporting Requirements

  • IH E2A and general requirements
  • Expedited reports
  • EU Clinical Trials Directive and detailed guidance
  • US IND requirements
  • Development Safety Update Reports (DSURs)

Pharmacoepidemiology Studies – Basic Designs, Strenghts, Weaknesses and Examples

  • Real world data is the King
  • Randomisation in the real world
  • Drugs and devices – its all “exposure”
  • Tracking all patients?

Where are We Now with PSURs (or PBRERs)

  • Evolution of the PSUR, PBRER and DSUR
    - ICH E2C, Volume 9A, GVP Module VII and ICH E2C (R2)…
  • What do we submit now and when is it required?
  • Practical aspects of compiling PSURs
  • The link between DSURs, RMPs, PSURs, and Core Safety Information

17.00 Close of day two

Day three

09.30 Drug Surveillance in Countries Outside Europe

  • US culture
  • NDA and IND safety reporting
  • Inspections
  • Japan culture
  • Post-marketing safety surveillance programmes in Japan
  • Pharmacovigilance in other countries

Practicalities of Signal Detection

  • Definitions of signals
  • Regulatory guidances on signal detection by industry and regulators
  • Resources for signal detection
  • Quantitative v qualitative signal detection

Examples of Pharmacoepidemiological Studies Used in Risk Management

  • Prescription event monitoring
  • Prospective observational cohort studies
  • Case control studies
  • Drug registries (anti-TNFs)
  • Pregnancy registries

Practicalities of Risk Management
A real world example of the development of a successful EU risk management plan

  • Requirements of risk management plans from an industry point of view
  • How to write a successful risk management plan
  • Reporting results of outcomes of activities in the risk management plan
  • Updating a 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:

  • Handling an important safety alert from regulators
  • Assessment of risk
  • Determining measures to respond to previously unidentified risks
  • Continuing assessmnet and communication of risk benefit

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.

Book now

3-5 Dec 2018
3-5 Dec 2018 Rembrandt Hotel, London GBP 1,849.00
EUR 2,589.00
USD 2,884.00
+ VAT @ 20.00%
Enrol now
24-26 Jun 2019
24-26 Jun 2019 Rembrandt Hotel, London GBP 1,849.00
EUR 2,589.00
USD 2,884.00
+ VAT @ 20.00%
Enrol now
2-4 Dec 2019
2-4 Dec 2019 Rembrandt Hotel, London GBP 1,849.00
EUR 2,589.00
USD 2,884.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • 4 Clinics
  • ABBOTT GmbH & Co KG
  • Acorus Calamus
  • Actavis UK Ltd
  • Actelion Pharmaceuticals
  • AstraZeneca SA
  • AstraZeneca SPA
  • Bells Healthcare
  • Celgene B.V
  • Centrafarm Pharmaceuticals BV
  • Cephalon UK Ltd
  • Colgate-Palmolive R&D
  • DR Reddys Laboratories Ltd
  • Eli Lilly & Co Ltd
  • Genzyme Europe BV
  • GlaxoSmithKline
  • Hospira UK Ltd
  • IBS Institut Biochimique SA
  • Johnson & Johnson
  • Laboratorios Leti SL Unipersonal
  • NorthStar Healthcare Ltd
  • Promed
  • Pure Drug Safety Ltd
  • Reckitt Benckiser
  • UCB Celltech
  • Voyage Tour LLC
  • Winthrop Pharmaceuticals UK Ltd
  • Worwag Pharma GmbH & Co. KG

A greatly organised and informative course given by driven and well informed speakers.

Willem van Lierop, Senior Drug Safety employee, ApotheekZorg

Exactly what we need. Very good.

Gabriel Georgescu, Regulatory Affairs Manager, Ewopharma AG

All the speakers are knowledgable and have good experience

Negin Goudarz, Pharmacovigilance Associate , Emas Pharma Ltd

The course was very useful and interesting to me personally

Darya Pospíšilová, Pharmacovigilance Project Manager, Arriello

Enjoyed the course. Although quite intense in the number of topics, it was well organized and stuck only to the important things. Would recommend and am thinking about continuing to The advanced PV one.

Marta Telebar, PV Project Specialist, Arriello s.r.o.

Very nice and informative course, very satisfied

Birgitte Wolf, PV Specialist, LEO Pharma

Found the content delivered from the speakers very good.

Priya Cutts, Report Specialist, Procter and Gamble Technical Centres Ltd

I was happy about the location, the presenters and the organizers for this course

Abdullah Al Dawood, QPPV and Regulatory Affairs Supervisor , Apotex Saudi Arabia

The course was well structured and covered all important aspects of PV. Everything was presented in clear presentations with helpful examples. Interactions between participants and speakers was easy and helpful.

Birte Hofmann, Director Pharmacokinetics Expert, Bayer AG

Overall I found the course to be very informative. Not only did I learn new information, but it helped me realise how much information I have picked up through my short time working in the industry and it reinforced this knowledge. I liked that there were a number of different speakers from different backgrounds who effectively cover different aspects of the topic in depth.

Sarah Bruce, Pharmacovigilance Officer, Kyowa Kirin

Excellent. Very good speakers and interactions.

Susanne Mathias, Senior GCP Advisor Specialist, Novo Nordisk A/S

Very passionate speakers

Sabrina Montante, Safety Scientist, GlaxoSmithKline

It was very good, I had a great time

Camille Soulet, Vigilances Training Officer, Pierre Fabre

High level training with great speakers, very good welcome and accommodation

Camille Soulet, Vigilances Training Officer, Pierre Fabre

I feel this course gives a good amount of information and is presented well. The speakers are very knowledgeable

Lee Rolfe, , Actavis plc

Well organised and the speakers were very knowledgeable

Claire McLaughlin, Drug Safety Specialist, Kyowa Kirin International

I think the course and its content were very well run and I would be happy to attend another course by Management Forum

Lee Rolfe, , Actavis plc

Very nice course which provides good instruction into PV and overall picture of PV requirements/obligations

Oresta Makaruha Stegic, FDF RA manager, xellia

Informative and well-organised but quite heavy going in parts

Gemma Anthony, PV & Regulatory Administrator, Meda Pharma Ltd

It was a comprehensive, professional course, well organized and beneficial

Liron Weisman, Pharmacovigilance Compliance Associate, Teva Pharmaceuticals Industries Ltd