Pharmacovigillance and Drug Safety
- Importance of Pharmacovigillance: Safety Monitoring of Medicinal Products
- Pharmacovigillance in Drug Regulation
- Monitoring Safety in Clinical Trials and Drug Development
- Role of Pharmacovigillance in drug development
- Post-marketing safety monitoring
- Adverse events reporting: Individual Case Safety Report (ICSR), Expedited reporting, Spontaneous & Aggregate reporting, Coding of adverse events etc.
- Risk management: Causality assessment, Risk management plans, Risk to benefit profile of drugs
- Pharmacoepidemiology, Pharmacogenetics and pharmacogenomics
- REMS/RMP design, Clinical Trials Registries
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Pharmacovigillance and Drug Safety Conference Speakers
Recommended Sessions
- Adaptive designs in Clinical Trials
- Bioethics and Regulatory Compliance in Clinical trials
- Challenges in Clinical Trials
- Clinical Research Operations & Project Management
- Clinical Trials Budgeting & Financial Management
- Clinical Trials Data Disclosure & Data Transparency
- Clinical Trials Design & Methodology
- Clinical Trials for Medical Devices
- Clinical Trials for various Diseases
- Clinical Trials Regulations
- Clinical Trials Supply & Management
- Data & Technology Driven Clinical trials
- Future of Clinical trials & Clinical Research
- Imaging in Clinical trials
- Interactive Response Technology (IRT) in Clinical Trials
- Outsourcing in Clinical Trials
- Patient Recruitment & Site Selection in Clinical trials
- Pharmacovigillance and Drug Safety
- Phases of Clinical Research: Current Trends & Future Developments
- Risk Management in Clinical Research & Clinical Trials
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