Research and Markets Adds Report: ‘Pharmacovigilance – A Basic Training Course for Those Working on Drug Safety Monitoring in the EU, USA and Japan…
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Research and Markets Adds Report: 'Pharmacovigilance - A Basic Training Course for Those Working on Drug Safety Monitoring in the EU,
In a release,
WHY YOU SHOULD ATTEND
This
WHO SHOULD ATTEND
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 THIS CONFERENCE:
-Principles of Pharmacovigilance and Data Resources
-Risk Management and the development of the Pharmacovigilance plan
-Causality Assessment: Clinical Diagnosis of Adverse Events
-Pharmacoepidemiology Studies
-Evolution of PSURs, PBRERs and DSURs
-Pro-active Pharmacovigilance Pre- and Post Marketing
-Pharmacovigilance Regulations (clinical trials & post marketing) including new EU Pharmacovigilance
-Risk/Benefit Analysis
-Drug Surveillance in countries outside
-Post-marketing Surveillance:
-Introduction to Signal detection
-Introduction to Risk Management plans
-
Key Topics Covered:
Day One
CHAIRMAN: PROF.
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
Professor
10.30 - Coffee
10.45 - Risk Management and Risk Minimisation: Basic Principles
-Basic principles
-Proactive strategies
-Development of the pharmacovigilance plan
Professor
11.30 - 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
Professor
12.30 - Discussion
12.45 - Lunch
CHAIRMAN:
14.00 - Regulatory Framework
-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
15.30 - Tea
15.45 - European Post-Marketing
-Pharmacovigilance Regulations
Overview of requirements which will include:
-The role of Pharmacovigilance Risk Assessment Committee
-Quality Management Systems and the Pharmacovigilance 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
17.15 - End of Day One and Drinks
Reception
Day Two
CHAIRMAN: DR
09.00 - 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
Dr
10.00 - Discussion
10.10 - Risk/Benefit Analysis
-Standardising risk/benefit analysis
-Putting risks into context
-Taking effective action and communicating effectively
Inga Bellahn, PhD
11.10 - Discussion
11.15 - Coffee
11.30 - 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)
Dr
12.35 - Discussion
12.45 - Lunch
CHAIRMAN: DR
14.00 - Pharmacoepidemiological Studies -
-Basic Designs, Strengths,
-Weaknesses and Examples
-Real World Data is the King
-Randomisation in the real world
-Drugs and devices- its all exposure
-Tracking all Patients?
Dr
15.30 - Tea
15.45 - 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
16.45 - Discussion
17.00 - End of Day Two
Day Three
CHAIRMAN: DR
09.00 - Drug Surveillance in Countries Outside Europe
-US culture
-NDA and IND safety reporting
-Inspections
-
-Post-marketing safety surveillance programmes in
-Pharmacovigilance in developing countries
Dr
10.00 - Discussion
10.15 - Post-marketing Surveillance: Observational Cohort Studies
-Monitoring events v monitoring ADRs
-Using observational cohorts for signal detection v signal clarification
-Strengths and pitfalls of observational studies
Dr
11.00 - Coffee
11.20 - Introduction to Signal Detection
-Definitions of signals
-Regulatory guidances on signal detection by industry and regulators
-Resources for signal detection
-Quantitative v qualitative signal detection
Dr
12.00 - Introduction to Risk Management Plans from the
-The details of the EU risk management plan and how successfully to write one
-Assessment of risk management plans by EU regulators
-Updating risk management plans and the link with the new PSUR Global risk management plans
-What to consider concerning operationalisation of risk management plans
-A real world case example of the development of an EU risk management plan
Dr
13.00 - Discussion
13.15 - Lunch
14.15 -
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 assessment and communication of risk benefit
Dr
16.00 - End of conference and Tea
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