Three Day Pharmacovigilance Course (London, United Kingdom - December 4-5-6, 2017) - Research and Markets
DUBLIN, Apr. 20, 2017 /PRNewswire/ --
Research and Markets has announced the addition of the "Pharmacovigilance" conference to their 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.
This three-day introductory course is aimed at personnel in research and development departments, adverse reaction monitoring units, regulatory affairs and registration departments; pharmaceutical physicians and drug safety officers. It will also be of direct benefit to all those who are involved and interested in the daily practice of pharmacovigilance.
Key Topics to Be Addressed at the Pharmacovigilance Conference:
- Principles of Pharmacovigilance and Data Resources
- Risk Management and Risk Minimisation
- Causality Assessment: Clinical Diagnosis of Adverse Events
- PASS and PAES Studies
- Regulatory Framework
- European Post-Marketing Pharmacovigilance Regulations
- Pharmacoepidemiological Studies
- Evolution of PSURs, PBRERs and DSURs - Pro-active Pharmacovigilance Pre- and Post Marketing
- Clinical Trial ADR reporting requirements
- Risk/Benefit Assessment
- Drug Surveillance in countries outside Europe
- Examples of pharmacoepidemiological studies used in risk management
- Introduction to Signal detection
- Introduction to Risk Management plans
- Practical Pharmacovigilance Workshop
Agenda:
Day 1 Schedule
09.00 Registration and coffee
09.30 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
The Current Regulatory Framework and its Global Impact
- Overview of European regulatory framework, including new EU pharmacovigilance legislation
- Implications for 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
- Risk Management Plans and Risk Minimisation
- Post Authorisation Safety and Efficacy studies (PASS/PAES)
- Additional Monitoring
- Pharmacovigilance Inspections/audit
- Public Hearings
- Stakeholder involvement initiatives such as PROTECT, WEB-RADR
17.15 End of Day One and Drinks Reception
Day 2 Schedule
09.30 Pro-Active 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 benefit/risk
- Monitoring the effectiveness of risk management measures
Clinical: Trial ADR Reporting Requirements
- IH E2A and general requirements
- Expedited reports
- EU Clinical Trials Directive and detailed guidance
- US IND requirements
- Development Safety Update Reports (DSURs)
Pharmacoepidemiology Studies - Basic Designs, Strenghts, Weaknesses and Examples
- Real world data is the King
- Randomisation in the real world
- Drugs and devices - its all exposure
- Tracking all patients?
Where are We Now with PSURs (or PBRERs)
- Evolution of the PSUR, PBRER and DSUR
- ICH E2C, Volume 9A, GVP Module VII and ICH E2C (R2)
What do we submit now and when is it required?
- Practical aspects of compiling PSURs
- The link between DSURs, RMPs, PSURs, and Core Safety Information
17.00 Close of day two
Day 3 Schedule
09.30 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 v qualitative signal detection
Examples of Pharmacoepidemiological Studies Used in Risk Management
- Prescription event monitoring
- Prospective 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
As requested by previous participants in this course, this session will comprise a practical case study with valuable hands-on experience covering:
- Handling an important safety alert from regulators
- Assessment of risk
- Determining measures to respond to previously unidentified risks
- Continuing assessmnet and communication of risk benefit
16.00 Close of day three
For more information about this conference visit http://www.researchandmarkets.com/research/2scctz/pharmacovigilance
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Research and Markets
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