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Drug Safety eLearning Program


Overview

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 postmarket 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:


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

-Previous Participant

Featured topics

  • Tracking a Case from Start to Finish
  • Assessing Cases
  • Referemce 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 hours to complete.

Who should attend?

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

Learning objectives

Module 1: Introduction to Drug Safety: Upon completion of this module, learners should be able to:

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

Module 2: Drug Safety Regulatory Requirements: Upon completion of this module, learners should be able to:

  • Identify key harmonization initiatives involved in drug safety
  • Identify important US regulations
  • Identify important EU regulations
  • Describe 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
  • Describe standard operating procedures (SOPs) that support drug safety

Module 3: Premarketing Clinical Trial Safety: Upon completion of this module, learners should be able to:

  • Discuss the purpose of  informed consent in clinical trials
  • Identify the 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 premarketing individual case reporting and aggregate reporting requirements
  • Discuss risk assessment in clinical trials
  • Explain the premarketing review of safety data in a marketing application

Module 4: Postmarketing Safety Management: Upon completion of this module, learners should be able to:

  • 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
  • Describe the efforts that have been made internationally to standardize benefit-risk assessment in the postmarketing phase
  • Compare risk management plan requirements in the EU with risk evaluation and mitigation strategies (REMS) that are required in the US during postmarketing

Module 5: Basics of Signal Detection and Pharmacoepidemiology: Upon completion of this module, learners should be able to:

  • 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: Upon completion of this module, learners should be able to:

  • Define audits and inspections, different types, and their scope
  • Describe FDA inspections and possible sanctions
  • Describe European Medicines Agency (EMA) and MHRA inspections, the legal basis for European inspections, the new European guideline on pharmacovigilance inspections, the MHRA’s risk-based approach, and possible sanctions
  • Describe the Health Canada safety inspections
  • Discuss inspection findings common to both FDA and MHRA, and to each agency individually
  • Describe how a company should respond to an FDA inspection, including the Corrective and Preventive Action (or CAPA) Plan
  • Explain best practices for the company's management of audits and inspections

 

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