Drug Safety eLearning Program
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Drug safety is a primary concern throughout the medical product development life cycle. The Drug Safety eLearning Program provides the knowledge you need, from regulations and requirements through premarket review and post-market monitoring. The online comprehensive program includes six self-paced modules that have been designed using the latest instructional strategies including microlearning and gamification to improve retention and make learning convenient for busy professionals. Each module is broken down in to bite-sized chunks of information that can typically be consumed in 5-10 minutes increments, preventing cognitive overload and improving learning outcomes. 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.The Drug Safety eLearning Program includes these six 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 InspectionsThe six modules take an average of 24 hours to complete.
Credit Information
ACPE: 24.25
IACET: 2.4
IACET: 2.4
Description
Featured Topics:
- Tracking a case from start to finish
- Assessing cases
- Reference safety information
- Harmonization initiatives
- Important US and EU regulations
- Individual case reporting
- Aggregate reporting
- Risk assessment
- Benefit-risk assessment
- Risk management plans
- Risk Evaluation and Mitigation Strategies (REMS)
- Safety signal basics
- Data mining
- Pharmacoepidemiology
- Types and scope of audits and inspections
- Common inspection findings
- Responding to an inspection
- Corrective and preventative action plans