Drug Safety eLearning Program
Buy all six modules and Save 20%!
Drug safety affects everyone involved in the drug development life cycle. The DIA's Drug Safety eLearning Program will provide a broad overview of safety regulations, requirements, and activities throughout the product life cycle from clinical trials, approval, to postmarketing activities. This program is designed for professionals involved in drug safety and pharmacovigilance, clinical research, marketing approval, and postmarketing activities. It will also benefit anyone working in related fields including regulatory affairs, clinical development, medical affairs, and quality assurance/compliance, who would like to enhance their knowledge and understanding of drug safety.
The Drug Safety eLearning Program is based on DIA’s popular Drug Safety training courses, Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum; Premarketing Clinical Safety and Pharmacovigilance; and Postmarketing Drug Safety and Pharmacovigilance. The eLearning 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. Continuing education credits are offered for each module in the Drug Safety eLearning Program.
All six modules will be launched in 2014. The modules can be purchased individually at $400 each, or save 20% today by purchasing all six modules*. Learners will have access to Module 1-5 immediately after purchase. When Module 6 is available, learners will be notified by email (see launch date below). Users will have one year from the date the module is launched to complete it.
Module 1: Introduction to Drug Safety Available Today!
- 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
Module 2: Drug Safety Regulatory Requirements Available Today!
- Harmonization Initiatives
- Important US Regulations
- Important EU Regulations
- Good Clinical and Pharmacovigilance Practices
- Standard Operating Procedures
Module 3: Premarketing Clinical Trial Safety Available Today!
- 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
Module 4: Postmarketing Safety Management Available Today!
- Spontaneous Case Reporting
- Aggregate Reporting
- Benefit-Risk Assessment
- Risk Management Plans
- Risk Evaluation and Mitigation Strategies (REMS)
- Postmarketing Case Studies
Module 5: Basics of Signal Detection and Pharmacoepidemiology Available Today!
- Safety Signal Basics
- Data Mining
- Safety Databases
- Mathematics of Drug Safety
Module 6: Safety Audits and Inspections
Scheduled Launch Date: October 2014
- Types and Scope of Audits and Inspections
- Common Inspection Findings
- Responding to an Inspection
- Corrective and Preventative Action Plan
* Purchase all six modules in one transaction and receive 20% off the purchase price.
DIA offers discounted rates to companies that are interested in purchasing eLearning modules for 10+ users! Users will be able to complete the modules on the DIA Learning Management System (LMS) or companies can choose to license the modules to host on their LMS. Licensed modules can be tailored to meet your needs. To request a proposal for multiple users contact Katie.Hill@diahome.org.