Drug Safety eLearning Program

Drug safety is a primary concern throughout the medical product development lifecycle. The Drug Safety eLearning Program provides the knowledge you need, from regulations and requirements through pre-market review and post-market monitoring. This 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 is divided into six modules and this package contains all six modules:

• Module 1: Introduction to Drug Safety
• Module 2: Drug Safety Regulatory Requirements
• Module 3: Pre-Marketing Clinical Trial Safety
• Module 4: Post-Marketing Drug Safety
• Module 5: Basics of Signal Detection and Pharmacoepidemiology
• Module 6: Safety Audits and Inspections

“Excellent module! Well organized and explained. I loved the interactive elements included to entertain and reinforce learning!”  

-Previous Participant

• 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 Plan

The six modules take an average of 24.25 hours to complete.

These modules are designed for professionals involved in:

• Drug safety and pharmacovigilance
• Clinical research and development
• Quality assurance and compliance
• Regulatory affairs
• Medical affairs
• Marketing

Upon completion of this program, learners should be able to:

Module 1: Introduction to Drug Safety

• Discuss the history, principles, and regulatory framework for clinical drug safety
• Define terms used in day-today pharmacovigilance work
• Describe a typical company drug safety unit and the path of a case from start to finish
• Identify reference safety information provided by the Investigator’s Brochure and post-marketing labeling
• Explain the assessment of seriousness, expectedness, and causality of adverse events

Module 2: Drug Safety Regulatory Requirements

• Identify key harmonization initiatives and important US and EU regulations
• Recognize the roles that the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and Council for International Organizations of Medical Sciences (CIOMS) play in drug safety regulations
• Describe good clinical and pharmacovigilance practices and standard operating procedures (SOPs) that support drug safety

Module 3: Pre-Marketing Clinical Trial Safety

• Identify the purpose and elements of informed consent in clinical trials
• Define the roles of institutional review boards, ethics committees, and data and safety monitoring boards in clinical trials
• Explain pre-marketing individual case reporting, aggregate reporting requirements, and review of safety data in marketing application
• Describe risk assessment in clinical trials

Module 4: Post-Marketing Safety Management

• Define spontaneous reporting and describe the spontaneous reporting system
• Discuss the requirements for aggregate reporting of adverse events in marketed products
• Explain the presentation of risks required in US labeling and the efforts that have been made internationally to standardize benefit-risk assessment in the post-marketing phase
• Compare risk management plan requirements in the EU with risk evaluation and mitigation strategies (REMS) that are required in the US during port-marketing

Module 5: Basics of Signal Detection and Pharmacoepidemiology

• Define a safety signal and list the activities in signal management.
• List different safety databases and the information each contains
• Explain the use of statistics in drug safety, data mining, and their role in signal detection
• Define pharmacoepidemiology and explain its role in drug safety management
• Explain signaling regulations and guidances in the US and EU, and CIOMS VIII principles for signal detection

Module 6: Safety Audits and Inspections

• Describe FDA inspections, possible sanctions, and how a company should respond to an FDA inspection, including the Corrective and Prevention Action (or CAPA) Plan
• Explain European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) inspections, the legal basis for European inspections, the new European guidelines on pharmacovigilance inspections, the MHRA’s risk-based approach, and possible sanctions
• Recognize Health Canada safety inspections and after-inspection activities
• Discuss inspection findings common to both FDA and MHRA, and to each agency individually
• Demonstrate best practices for the company’s management of audits and inspections