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Pharmacovigilance Training Course
Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.
Details
Course overview
This comprehensive three-day course has been designed to provide an introductory guide for all those concerned with pharmacovigilance. The interactive programme will cover topics from basic pharmacovigilance principles and terminologies through to the current regulatory framework and its global impact, including drug surveillance in the EU, US and Japan. Proactive pharmacovigilance pre- and post-marketing will be addressed as will risk management, the challenges of causality assessments and effective signal detection.
Our panel of experts will offer practical guidance throughout the course and use real-world examples and case studies to contribute to the development of your knowledge. There will also be ample opportunity to share experiences with the speakers and fellow professionals, which will further enhance your understanding of pharmacovigilance issues.
Key topics to be addressed include:
- Principles of pharmacovigilance and data resources
- Risk management, causality assessment and postauthorisation safety and efficacy studies (PASS/PAES)
- Pharmacoepidemiological studies and evolution of periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRERs) and development safety update reports (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 (RMPs)
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
Programme
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
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 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
- 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
- RMPs and risk minimisation
- 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
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
Risk-benefit assessment
- General principles
- Quantifying risk
- Taking action to optimise risk-benefit
- Monitoring the effectiveness of risk management measures
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
- DSURs
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
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 RMP
- Requirements of RMPs from an industry point of view
- How to write a successful RMP
- Reporting results of outcomes of activities in the RMP
- Updating a RMP
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
Glyn Belcher (More...) (21-23 Jun 2021, 6-8 Dec 2021)
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.
Book now
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21-23 Jun 2021 Face-to-face, (venue not yet confirmed) |
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21-23 Jun 2021 Face-to-face (venue not yet confirmed) |
GBP 1,849 1,549 EUR 2,589 2,169 USD 2,884 2,416 Until 10 May* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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6-8 Dec 2021 Face-to-face, (venue not yet confirmed) |
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6-8 Dec 2021 Face-to-face (venue not yet confirmed) |
GBP 1,849 1,549 EUR 2,589 2,169 USD 2,884 2,416 Until 25 Oct* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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* Note the early booking discount cannot be combined with any other offers or promotional code