Drug Safety eLearning Bundle
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Keyword(s)
Drug safety, Pharmacovigilance, Good pharmacovigilance practices, Quality assurance, Adverse events, Compliance, Safety regulations, Risk Assessment, Clinical trial safety, Spontaneous reports, Aggregate reporting, Benefit-risk Assessment, Risk Minimization Plans, Risk Evaluation and Mitigation Strategies (REMS), Signal detection, Pharmacoepidemiology, Data mining, Safety audits, Inspections, Pharmacovigilance, Epidemiology, Pharmacology, Pharmacogenomics, Pharmacogenetics
Drug safety is a primary concern throughout the medical product development life cycle. This bundle will help build a solid foundation in the key concepts of drug safety and pharmacovigilance throughout the medical product development lifecycle.The Drug Safety eLearning Bundle includes seven self-paced modules:
- Introduction to Drug Safety
- Drug Safety Regulatory Requirements
- Pre-marketing Clinical Trial Safety
- Post-marketing Safety Management
- Basics of Signal Detection and Pharmacoepidemiology
- Safety Audits and Inspections
- Basic Safety Sciences: Pharmacoepidemiology, Clinical Pharmacology, Pharmacogenomics, and Toxicology Studies
Learners have access to the eLearning modules 24 hours a day, 7 days a week for one full year, and are mobile compatible making it easy to learn on the go! Continuing education credits are offered for all modules.
Credit Information
ACPE: 31.25
IACET: 3.1
IACET: 3.1
Description
Featured Topics:
- Assessing cases
- Reference safety information
- Harmonization initiatives
- Important US and EU regulations
- Individual case and aggregate reporting
- Benefit-risk assessment
- Risk management plans and Risk Evaluation and Mitigation Strategies (REMS)
- Safety signal basics and data mining
- Types and scope of audits and inspections
- Common inspection findings
- Responding to an inspection
- Corrective and preventative action plan
- Toxicology
- Clinical pharmacology
- Pharmacogenomics
- Pharmacoepidemiology