DUBLIN–(BUSINESS WIRE)–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 in 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/h53c27
Contacts
ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
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Related
Topics: Drug
Discovery