Real-World Evidence in Pharmacoepidemiology


Course Info

Code IND5 - 155

Duration 5 Days

Format Classroom, Online

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Real-World Evidence in Pharmacoepidemiology

Day 5 of each course is reserved for a Q&A session, which may occur off-site. For 10-day courses, this also applies to day 10

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Course Summary

This advanced course thoroughly explores real-world evidence (RWE) in pharmacoepidemiology. Participants will explore the methodologies for generating and analysing RWE and understand its applications in drug safety, effectiveness, and public health decision-making. The course integrates theoretical knowledge with practical applications, preparing participants to use RWE effectively in various contexts.


Upon completion of this course, participants will be able to:

  • Understand the principles and importance of real-world evidence in pharmacoepidemiology.
  • Develop skills in designing and conducting real-world studies.
  • Learn advanced methods for analysing real-world data.
  • Interpret and communicate real-world evidence to inform healthcare decisions.
  • Explore the latest advancements and applications of RWE in drug safety and public health.

This course is intended for 

  • Pharmacoepidemiologists
  • Public health professionals
  • Medical researchers
  • Healthcare practitioners involved in drug safety and effectiveness
  • Data analysts in health sciences
  • Graduate students in public health, epidemiology, and related fields

The course employs a blend of instructional methods, including:

  • Interactive lectures
  • Hands-on data analysis sessions
  • Group discussions and case studies
  • Expert-led Q&A sessions
  • Comprehensive course materials and resources

Course Content & Outline

Section 1: Introduction to Real-World Evidence

  • Definition and significance of real-world evidence
  • Key differences between clinical trial data and real-world data
  • Sources of real-world data: electronic health records, registries, and claims data

Section 2: Study Design and Data Collection

  • Designing real-world studies: cohort, case-control, and cross-sectional studies
  • Data collection methods and tools
  • Ensuring data quality and integrity

Section 3: Advanced Data Analysis Techniques

  • Statistical methods for analysing real-world data
  • Propensity score matching and instrumental variable analysis
  • Handling biases and confounding factors in real-world studies

Section 4: Applications of Real-World Evidence

  • Evaluating drug safety and effectiveness
  • Informing regulatory decisions and health policy
  • Case studies: Applications of RWE in various therapeutic areas

Section 5: Practical Applications and Case Studies

  • Hands-on data analysis with real-world datasets
  • Developing and presenting real-world evidence projects
  • Collaborative problem-solving and case studies
  • Course review, expert Q&A, and certification ceremony

Certificate Description

Upon successful completion of this training course, delegates will be awarded a Holistique Training Certificate of Completion. For those who attend and complete the online training course, a Holistique Training e-Certificate will be provided.

Holistique Training Certificates are accredited by the British Assessment Council (BAC) and The CPD Certification Service (CPD), and are certified under ISO 9001, ISO 21001, and ISO 29993 standards.

CPD credits for this course are granted by our Certificates and will be reflected on the Holistique Training Certificate of Completion. In accordance with the standards of The CPD Certification Service, one CPD credit is awarded per hour of course attendance. A maximum of 50 CPD credits can be claimed for any single course we currently offer.