INTRODUCTION
The pharmaceutical industry is challenged with providing oversight of a drug’s safety throughout the product lifecycle. This includes continually reviewing safety profiles and managing and assessing benefits and risks that arise during and after drug development. Thiscourse provides detailed coverage of the key pharmacovigilance concepts, global pharmacovigilance systems and regulations according to Good Pharmacovigilance Practice guidelines that support the development of optimal pharmacovigilance programmes.
PROGRAM OBJECTIVES
- Introducing ADRs and PV
- Reporting spontaneous adverse reaction
- Learning requirements and recommendations to set up PV system
- Mastering effective communication in pharmacovigilance
- Examining pharmacovigilance in Public Health Programmes , vaccines, herbals and PV methods
WHO SHOULD ATTEND?
- Drug Safety / Pharmacovigilance Staff
- Regulatory Affairs Staff
- Clinical Development Staff
- Clinical Research Organisation Staff
PROGRAM OUTLINE
- The Concept of Pharmacovigilance and Methodology
- Background and International Context
- General Information on Reporting System
- GPP General Principles
- Setting up National Pharmacovigilance Systems and Centers
- Basic Activities for Setting up a Pharmacovigilance Center
- PV Documentation, Characteristics of Reports and Other Documents
- Computer Systems
- Management of Reports (Submitting Reports, Data Coding and Entry, Characteristics of Reporting
- Review of the Database, Assessing Reports)
- Pharmacovigilance in Clinical Studies
- Identification of Risks
- Descriptive Analysis of a Series of Cases
- Use of Data Mining to Identify Associations between Medicines and Adverse Events
- Generation of Signals
- Quantification of Risks
- Quantification of the Strength of Association
- Studies to Quantify Risks
- Risk Assessment, Assessment of the Benefit/Risk Ratio
- Risk Management and Communication
- Periodic Safety Update Reports
- Publication and Information in Pharmacovigilance
- Crisis Management
- Risk Prevention
- Evaluation of the Pharmacovigilance System
- National Regulatory Authority
- Essential Elements of Effective Pharmacovigilance
- Relations with Marketing Authorization Holders
- Certification of GPP in the Pharmaceutical Industry
- National Pharmacovigilance System
- National and Local Pharmacovigilance Centers
- Public Health and Immunization Programs
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