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Drug Safety eLearning Bundle

Learn about basics of drug safety and safety sciences in this seven module eLearning bundle.


Overview

The Drug Safety eLearning Bundle includes seven self-paced modules:

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 seven modules take an average of 30.5 hours to complete.

Featured topics

  • Assessing Cases
  • Reference Safety Information
  • Harmonization Initiatives
  • Important US and EU Regulations
  • Individual Case and Aggregate Reporting
  • Benefit-Risk Assessment
  • Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS)
  • Safety Signal Basics and Data Mining
  • Types and Scope of Audits and Inspections
  • Common Inspection Findings
  • Responding to an Inspection
  • Corrective and Preventative Action Plan
  • Toxicology
  • Clinical Pharmacology
  • Pharmacogenomics
  • Pharmacoepidemiology

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
  • Medical writing

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

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

  • 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: 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 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: 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

Module 7: Basic Safety Sciences: Pharmacoepidemiology, Clinical Pharmacology, Pharmacogenomics, and Toxicology Studies: Upon completion of this module, learners should be able to:

  • Summarize the basics of toxicology studies and the limitations in predicting human toxicity
  • Articulate the basic principles of clinical pharmacology and pharmacogenomics
  • Summarize principles of pharmacoepidemiology and other drug safety sciences to analyze potential safety issues and better understand the patient population

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