Pharmacovigilance

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

KEY TOPICS TO BE ADDRESSED AT THE 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

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

• 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

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

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

Saad Shakir

Saad Shakir is Director of the Drug Safety Research Unit, Southampton, UK. He qualified in Medicine in 1976 and worked in hospital medicine for eleven years before moving to general practice. He has been working in pharmacovigilance & pharmacoepidemiology for more than a decade, initially at the Medicines Control Agency (MCA) in the UK then at the international pharmaceutical industry. He was appointed as the Director of the Drug Safety Research Unit (DSRU) in Southampton in 1999. The DSRU is an academic Unit associated with the University of Portsmouth. At the DSRU he leads a research team with an active programme for monitoring and studying the safety of medicines. He is a Fellow of the Royal Colleges of Physicians in Glasgow, Edinburgh and London, a Fellow of the Faculty of Pharmaceutical Medicine and a Member of the Royal College of General Practitioners in the UK. He continues to practice clinical medicine part-time. He has worked and advised on many drug safety issues including product withdrawals and major safety hazards. He is an author of many publications in scientific journals on pharmacovigilance and pharmacoepidemiology and is a member of the editorial boards of the journals of Pharmacoepidemiology and Drug Safety. He has led, co-ordinated and participated in many postgraduate educational and training programmes. He supervises postgraduate students for higher degrees and has been involved with a number of international initiatives to promote and develop pharmacovigilance and pharmacoepidemiology.

Carol Markwell

Carol Markwell is Director and 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

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.

John Talbot

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

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

William Richardson was previously Medical Assessor (Senior Medical Assessor from 2004)at the Medicines and Healthcare products Regulatory Agency, UK, and prior to that Senior Medical Adviser, Corporate Drug Safety, Boehringer Ingelheim GmbH, Germany. He has over 25 years of regulatory affairs and pharmaceutical medicine experience, from clinical development to post-marketing. Clinical assessment of drug safety aspects of marketing authorisation applications in a wide range of therapeutic areas particularly immunosuppressants including TNF inhibitors including biosimilar infliximab; epoetins and biosimilars; oncology products including thalidomide and analogues, and vascular endothelial growth factor (VEGF) inhibitors; anaesthetic agents/ICU medicines. Assessment of new drugs, biologics, generics and EU safety referrals and major changes to marketing authorisations. Expert in pharmacovigilance and risk management – risk:benefit evaluation, risk management planning and scientific advice in the context of the pharmacovigilance legislation introduced in 2012. Training in pharmacovigilance particularly risk:benefit evaluation.

Ian Douglas

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.

Shelley Gandhi

Shelley Gandhi joined NDA Group AB in 2012 and previously was with the MHRA (UK Regulatory Authority) for 19 years. She has extensive knowledge of all European regulatory processes relating to monitoring the safety of licensed medicinal products and ancillary devices and has investigated possible risks and has taken appropriate actions to minimise risk to public health through both European and National Committees.
She was Vigilance and Intelligence Research Group Unit Manager where she led a team of 30 whose primary role is to carry out risk assessment. In her final year at the MHRA, she mainly focussed on delivering the new pharmacovigilance legislation in Europe and ensuring the MHRA would be ready.
She is currently using this regulatory experience to work with industry to ensure they implement the new pharmacovigilance legislation.

• Actelion Pharmaceuticals
• Alcon Laboratories (UK) Ltd
• Amgen LLC
• Astellas BV
• Baxter Innovations GmbH
• Bells Healthcare
• British American Tobacco Ltd
• Cephalon UK Ltd
• Chugai Pharma Europe Ltd
• Ewopharma International sro
• GlaxoSmithKline Services Unlimited
• Hospira UK Ltd
• Immunocore Limited
• INVERNESS MEDICAL INNOVATIONS LTD
• Laboratorios Almirall S A
• Maccabi Healthcare Services
• MERCK SHARP & DOHME
• Octapharma Ltd
• Pinewood Healthcare Ltd.
• Poslovni centar Hemofarm
• QA Pharmaceutical Services
• Reig Jofre Group
• Sanofi-Aventis
• Saudi Food and Drug Authority
• Scottish National Blood Transfusion Service
• South Devon Healthcare NHSTrust
• Teva Czech Industries S R O
• Warner Chilcott Pharmaceuticals UK Ltd
• Wyeth Europa Ltd
• Wyeth Pharmaceuticals