Drug Safety eLearning Program
Drug safety is a primary concern throughout the medical product development life cycle. Developed with DIA expertise to meet the unique needs of its stakeholders and members, the Drug Safety eLearning Program* provides the knowledge you need, from regulations and requirements through premarket review and postmarket monitoring. The online program includes six self-paced modules that can be accessed 24 hours a day, 7 days a week. Modules do not have to be taken in one sitting; users can start/stop at any time and begin where they left off. Users will have one year to complete the modules and continuing education credits are offered. The modules can be purchased individually at $400 each, or save 20% today by purchasing all six modules.
Approved by the Regulatory Affairs Professionals Society for 6 RAC credits.
Explore the Drug Safety eLearning Program, Watch a Short Video!
- Drug Safety: The Basics
- A “Typical” Company Safety Unit
- Tracking a Case from Start to Finish
- Assessing Cases
- Reference Safety Information: The Investigator Brochure and Postmarketing Labeling
- Harmonization Initiatives
- Important US Regulations
- Important EU Regulations
- Good Clinical and Pharmacovigilance Practices
- Standard Operating Procedures
- Informed Consent
- Institutional Review Board/Ethics Committee
- Individual Case Reporting
- Aggregate Reporting
- Risk Assessment
- Premarketing Review of Safety Data in an Application
- Data Safety Monitoring Boards
- Spontaneous Case Reporting
- Aggregate Reporting
- Benefit-Risk Assessment
- Risk Management Plans
- Risk Evaluation and Mitigation Strategies (REMS)
- Postmarketing Case Studies
- Safety Signal Basics
- Data Mining
- Safety Databases
- Mathematics of Drug Safety
- Types and Scope of Audits and Inspections
- Common Inspection Findings
- Responding to an Inspection
- Corrective and Preventative Action Plan
DIA and Rutgers School of Health Related Professions Biopharma Educational Initiative (Rutgers-SHRP-BEI) have partners to offer academic credit to learners completing the DIA Drug Safety eLearning course in conjunction with Rutgers online companion course.
* The Drug Safety eLearning Program is based on DIA’s popular Drug Safety training course, Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum.