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

News provided by

May 23, 2019, 10:30 ET

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

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Media Contact:

Research and Markets
Laura Wood, Senior Manager
[email protected]

For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets