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Three Day Pharmacovigilance Course: Understanding PhV Today in Europe, the USA and Japan - London, United Kingdom - June 24th-26th, 2019

DUBLIN, May 23, 2019 /PRNewswire/ -- The "Pharmacovigilance - Understanding PhV Today" conference has been added to ResearchAndMarkets.com's offering.

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.

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
  • Post-marketing surveillance: observational cohort studies
  • An overview of signal detection and risk management plans

Who Should Attend:

All those 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

Agenda:

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 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 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 and detailed guidance (CT-3)
  • 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

For more information about this conference visit https://www.researchandmarkets.com/r/5rjh5j

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SOURCE Research and Markets