Pharmacovigilance

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

2-4 Dec 2019

& 22-24 Jun 2020 , 7-9 Dec 2020

GBP 1,849 1,549 *
EUR 2,589 2,169 *
USD 2,884 2,416 *
* When you book before 24 Oct

Book now

Course overview

This course aims to provide basic training for all 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.

Key topics to be addressed include:

  • Principles of pharmacovigilance and data resources
  • Risk management, causality assessment and PASS/PAES studies
  • Pharmacoepidemiological studies and evolution of PSURs, PBRERs and DSURs
  • Proactive pharmacovigilance pre- and post-marketing, risk-benefit assessment
  • Pharmacovigilance regulations, clinical trial ADR reporting requirements n Drug surveillance in countries outside Europe
  • Drug surveillance in countries outside Europe
  • Post-marketing surveillance: observational cohort studies
  • An overview of signal detection and risk management plans

Who should attend?

Anybody involved and interested in the daily practice of pharmacovigilance, including pharmaceutical physicians and those working in:

  • Drug safety
  • Adverse reaction monitoring
  • R&D
  • Regulatory affairs
  • Registration

Day one

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

Discussion session

The current regulatory framework and its global impact

  • Overview of European regulatory framework, including 2012 EU pharmacovigilance legislation
  • Implications for the 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 the Pharmacovigilance Risk Assessment Committee (PRAC) and SCOPE initiative
  • Quality management systems and the pharmacovigilance system master file (PSMF)
  • QPPV
  • Expedited reporting: solicited vs spontaneous
  • Periodic reports and signal management and use of EudraVigilance
  • Risk management plans and risk minimisation
  • Post-authorisation safety and efficacy studies (PASS/PAES)
  • Additional monitoring
  • Pharmacovigilance inspections/audit
  • Public hearings including first EMA hearing – September 2017
  • Stakeholder involvement initiatives such as PROTECT, WEB-RADR
  • New electronic reporting standards, E2B (R3), IDMP

Day two

Proactive 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

Discussion session

Risk-benefit assessment

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

Discussion session

Clinical trial ADR reporting requirements

  • ICH E2A and general requirements
  • Expedited reports
  • EU Clinical Trials Directive, Clinical Trial Regulation and detailed guidance
  • US IND requirements
  • Development safety update reports (DSURs)

Discussion session

Pharmacoepidemiological studies – basic designs, strengths, weaknesses and examples

  • Real-world data is the king
  • Randomisation in the real world
  • Drugs and devices – it’s all ‘exposure’
  • Tracking all patients?

Periodic reporting – PSURs and PBRERs

  • Evolution of the PSUR, PBRER and DSUR
  • What do we submit and when to submit it
  • Practical aspects of compiling PSURs and PBRERs
  • Linking DSURs, RMPs, PSURs, PBRERs and core safety Information

Discussion session

Day three

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 vs qualitative signal detection

Examples of pharmacoepidemiological studies used in risk management

  • How we weigh evidence
  • 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

A practical case study with valuable hands-on experience:

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

Presenter

Seema Jaitly (2-4 Dec 2019)

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

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%
GBP 1,549.00
EUR 2,169.00
USD 2,416.00
Until 24 Oct*
Enrol now
22-24 Jun 2020
22-24 Jun 2020 Rembrandt Hotel, London GBP 1,849.00
EUR 2,589.00
USD 2,884.00
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.
7-9 Dec 2020
7-9 Dec 2020 Venue not yet confirmed GBP 1,849.00
EUR 2,589.00
USD 2,884.00
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.

* Note the early booking discount cannot be combined with any other offers or promotional code

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Previous customers include...

  • 4 Clinics
  • Abbott Laboratories
  • Actelion Pharmaceutical Ltd
  • Adamas Consulting Ltd
  • AstraZeneca SA
  • AVENTIS PHARMA
  • Bayer Pharma AG
  • Bells Healthcare
  • Colgate Palmolive Research & Development Inc
  • DBV Technologies
  • Department of Health
  • Emas Pharma Ltd
  • Ewopharma AG
  • Faes Farma S.A.
  • Ferring Ireland Ltd
  • Ferring Pharmaceuticals Ltd
  • Genus Pharmaceuticals Ltd
  • H. Lundbeck A/S
  • Hospira UK Ltd
  • Medac GmbH
  • Novo Nordisk
  • Pierre Fabre Medicament
  • Promed
  • Reig Jofre Group
  • SCHERING HEALTH CARE LTD
  • Speedel
  • UCB Pharma SA
  • Unilever
  • University of Bradford
  • Winthrop Pharmaceuticals UK Ltd

The course gave overall understanding on pharmacovigilance. The presentations were clear and with helpful examples. Interaction between participants and speakers was great. All the speakers have good experiences and knowledge.

Teodora Crowe-Wijasa, Consultant Medical Safety Physician, DADA Consultancy BV

Workshop is very good because you have to USE the knowledge you gain. Interaction between speaker and attendees is very good too!

Anna Bøgelund Møller, Pharmacovigilance scientist, Larix

Obviously all speakers have huge experiences within the PV processes.

Haiping Ma, Senior Safety Quality Professional, Novo Nordisk A/S

Amazing speakers with a wealth of knowledge and experience.

Dalal Abdulaziz, Regulatory Manager, Al Hafez Trading Est

Co-ordinators were great, material provided was concise and well presented. Time for breaks and lunches were spot on. Most of the speakers were excellent. I have 18 months experience in PV and I felt like the course was at my level. This course is not suitable for beginners.

Bhupesh Panchal, Drug Safety & Information Officer, Wockhardt UK Limited

Expert presenters with engaging and thoughtful presentations that allow plenty of time for questions and discussion. All very knowledgeable and engaging.

Sam Allen, Drug Safety Operations Medic, Mundipharma Research Ltd.

My overall opinion is very positive, I am not disappointed at all. Speakers did a very good job - being approachable, giving examples, sharing his/her professional experiences, etc. Very knowledgeable speakers with relevant experience.

Vania Horta, Drug Safety & Information Officer , Wockhardt UK Limited

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

Very nice and informative course, very satisfied

Birgitte Wolf, Senior Safety Specialist , LEO Pharma

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.

Found the content delivered from the speakers very good.

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

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

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

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

Camille Soulet, Vigilances Training Officer, Pierre Fabre

Well organised and the speakers were very knowledgeable

Claire McLaughlin, Drug Safety Specialist, Kyowa Kirin International

Excellent. Very good speakers and interactions.

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

It was very good, I had a great time

Camille Soulet, Vigilances Training Officer, Pierre Fabre

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

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

Very passionate speakers

Sabrina Montante, Safety Scientist, GlaxoSmithKline

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

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

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

Liron Weisman, Pharmacovigilance Compliance Associate, Teva Pharmaceuticals Industries Ltd

Informative and well-organised but quite heavy going in parts

Gemma Anthony, PV & Regulatory Administrator, Meda Pharma Ltd