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Eu2P Course Domains
- Basics for pharmacovigilance and pharmacoepidemiology
- Benefit assessment of medicines
- Medicines pharmacovigilance and regulatory aspects
- Medicines risk identification and quantification
- Medicines benefit-risk assessment
- Medicines and public health
- Medicines risk communication
- American programme in pharmacovigilance
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Short Courses
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- Basics for pharmacovigilance and pharmacoepidemiology
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Benefit assessment of medicines
- Domain Overview
- Heterogeneity of treatment effect in clinical trials
- Selecting outcomes: Surrogate endpoints
- Fundamentals of the adaptive clinical trials
- Fundamentals of the network meta-analysis
- Strategies for handling missing data in clinical trials
- Composite outcomes in clinical trials
- Early stopping rules in clinical trials
- Non inferiority approach in clinical trials
- Recruitment strategies in clinical trials
- Minimal clinically important differences in clinical trials
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Medicines pharmacovigilance and regulatory aspects
- Domain Overview
- Pre-Marketing Pharmacovigilance Legislation
- Post-Marketing Pharmacovigilance Legislation
- EudraVigilance and EVMPD
- Development Safety Update Report (DSUR)
- International Harmonisation Initiatives
- Guidelines for Good Pharmacoepidemiology Practices
- Vaccines biologics Regulations
- Device vigilance and surveillance
- US Regulations
- Japanese Regulations
- French Regulations
- Contractual Agreements in PV
- Canadian Pharmacovigilance regulations
- GVP Module I - Pharmacovigilance Quality Management System
- GVP Module II - Pharmacovigilance System Master File (PSMF)
- GVP Module III - PV Inspections
- GVP Module IV - PV Audits
- GVP Module V - Risk Management System
- GVP Module VI - Collection, management and submission of reports of suspected ADR to Medicinal Products
- GVP Module VII - Periodic Safety Update Report (PSUR)
- GVP Module VIII - Post-Autorisation Safety Studies (PASS)
- GVP Module IX - Signal Management
- GVP Module XVI - Risk Minimisation Measures
- Signal Detection
- Validation of Computerized Systems
- Management and Reporting of ADR
- Gestión y Notificación de RAM
- Risk management plans and European Union regulatory perspective
- Principles of labeling and Summary of Product Characteristics (SmPC)
- Role of the Qualified Person Responsible For Pharmacovigilance (QPPV)
- Medicines risk identification and quantification
- Medicines benefit-risk assessment
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Medicines and public health
- Domain Overview
- Health care records from large databases as a tool to study the use of medicines
- Integrating Pharmacovigilance and consumption data analysis - uses, limitations and potentiality
- From individual cases to the community impact of adverse drug reactions: measuring tools
- From individual cases to the community impact of adverse drug reactions: limitations
- Risk Management Plans: the value of concomitant medication
- Risk Management Plans: the effects of inappropriate use of the target medicine
- Interpretation of drug consumption data - uses and limitations in common practice
- Identification of dispensable and redundant medication in the population
- Bone fracture associated with common medication - an example of the Public Health impact estimation
- Intracranial bleeding associated to medicines - From systematic reviews and meta-analyses to consumption databases
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Medicines risk communication
- Domain Overview
- Why communicate? Specificity of health communication
- Basis of risk communication with special focus on risk communication on medicines
- Understand communication challenges facing the regulatory agencies
- How can risk communication be minimized?
- Concept of risk communication throughout modern time
- How do risk perception and risk communication hang together
- Risk perception. How to deal with it in risk communication?
- Communicating emerging safety risks of marketed medicines
- A case study: the pandemic influenza vaccine
- How to measure the effectiveness of risk communication?
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American programme in pharmacovigilance
- Domain Overview
- US-EU Regulations: principles and comparison
- Overview of the Legal Basis of PV Regulations and the Role of the QPPV
- Principles of Labeling and Description of United States Prescribing Information (USPI)
- Pharmacovigilance in Combination Products and Regulations
- From individual cases to the community impact of adverse drug reactions: measuring tools
- Aggregate reporting in the US
- Vaccines Biologics Regulations
- Gene therapy
- Pharmacovigilance for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT-Ps)
- Targeted Therapeutics
- FDA Adverse Event Reporting System (FAERS)
- FDA Sentinel System
- Health care records from large databases as a tool to study the use of medicines
- Integrating Pharmacovigilance and consumption data analysis - uses, limitations and potentiality
- Principles and methods of benefit-risk assessment in decision-making of medicines
- Role of benefit-risk assessment and pharmaco-economics in decision-making of medicines
- Concepts in Risk Management
- Organization for risk management in the industry
- Risk Evaluation and Mitigation Strategy (REMS)
- Scope and Background on Medication Errors
- Medication Error Pharmacovigilance
- Minimizing Medication Errors Related to Nomenclature
- Minimizing Medication Errors Related to Product Design
- Optimizing Labeling and Packaging to Minimize Medication Errors
- Human Factors and its Role in Preventing Medication Errors
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Browse by domain
- Basics for pharmacovigilance and pharmacoepidemiology
- Benefit assessment of medicines
- Medicines pharmacovigilance and regulatory aspects
- Medicines risk identification and quantification
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Medicines benefit-risk assessment
- Domain Overview
- Introduction to benefit-risk assessment and pharmacoeconomics in decision making
- Principles of pharmacoeconomics and valuation of health states
- Fundamentals of quantitative benefit-risk assessment methods in decision making on medicines
- Advanced quantitative benefit-risk assessment methods in decision making on medicines
- Medicines and public health
- Medicines risk communication
- American programme in pharmacovigilance
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