Guidelines for Good Pharmacoepidemiology Practices Course

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February 13 to June 28, 2019

Researchers from RTI Health Solutions will be teaching a short course on good pharmacoepidemiology practices through the European programme in Pharmacovigilance and Pharmacoepidemiology (Eu2P).

Objectives

This course intends to give you an overview of the Guidelines for Good Pharmacoepidemiology Practices by providing you with:

  • A description of the protocol for pharmacoepidemiologic research
  • An overview of the origin and key elements of the most relevant guidance for good pharmacoepidemiology practice
  • An overview of the guidelines for good pharmacoepidemiology practice in regards to responsibilities, personnel, facilities, resource commitment, and contractors
  • An overview of the principles of human data protection and key aspects of data collection, management, and verification in pharmacoepidemiologic studies
  • Guidelines for analysis and reporting of pharmacoepidemiologic research
  • An overview of the key guidance on best practice in the communication and dissemination of information about pharmacoepidemiology studies
  • An overview of the guidelines on adverse drug events reporting and archiving practices in pharmacoepidemiologic studies

Learning Outcomes

By the end of the training you will be able to :

  • Access the tools that are available to support good practice in the area of pharmacoepidemiology
  • Identify the need for a protocol, the elements of a protocol, and tools to check the completeness and quality of a protocol and access examples in the EU PAS® Register
  • Become familiar with aspects relating to responsibilities, personnel, facilities, resource commitment, and contractors and the data protection regulations and ethics requirements and data collection principles in pharmacoepidemiologic studies
  • Understand the rationale for and key components of a statistical analysis plan
  • Plan and implement efficient and effective communication and dissemination of information about pharmacoepidemiology studies
  • Become familiar with the key concepts and the requirements regarding reporting adverse events related to drugs as well as the guidance for archiving of study materials
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