Medical Affairs: Evidence Generation

Build foundational evidence-generation skills, including clinical trial design, real-world evidence, literature searching, and critical appraisal to support informed Medical Affairs decision-making.

Build evidence generation capability in Medical Affairs.

Medical Affairs professionals play a critical role as stewards of scientific evidence, supporting decision-making and engagement across the healthcare ecosystem. This course provides a structured introduction to the core principles of evidence generation and interpretation, equipping participants with the foundational skills required to work effectively in Medical Affairs roles. 

 

Why enrol? 

As the volume and complexity of healthcare data continue to grow, the ability to interpret clinical evidence and apply it appropriately is now a core capability for Medical Affairs professionals. Many early-career practitioners lack formal training in clinical trial design, real-world evidence, and literature appraisal. This course addresses that gap by building essential evidence literacy and confidence.

What will you learn?

Participants will develop a practical understanding of:

  • Clinical trial design fundamentals, including phases, randomisation, blinding and endpoints
  • Differences between clinical trial data and real-world data/evidence
  • Principles of Good Publication Practice (GPP)
  • Structured literature searching using scientific databases
  • Techniques for critically appraising published studies
  • Data-informed decision-making in Medical Affairs contexts 

Through guided learning and applied activities, participants will strengthen their ability to assess evidence quality, identify appropriate sources, and contribute meaningfully to scientific discussions under supervision.  

Course Highlights

  • Designed specifically for Medical Affairs professionals
  • Industry-aligned and practical learning approach
  • Self-paced online delivery with flexible access
  • Focus on real-world application of evidence generation 
  • Builds a critical foundation for scientific engagement

 
Who Should Attend

  • Medical Affairs professionals (MSLs, Advisors, Managers)
  • Professionals transitioning into Medical Affairs roles
  • Healthcare or industry professionals seeking foundational knowledge

Topics

  • Clinical trial design and methodology
  • Randomised controlled trials vs real-world evidence
  • Literature search techniques (e.g. PubMed)
  • Critical appraisal of scientific studies
  • Good Publication Practice (GPP)
  • Data-informed decision-making
  • Evidence generation across the product lifecycle 

Learning Outcomes

By the end of this course you will be able to:
Explain key clinical trial designs and their strengths and limitations
Differentiate between RCT data and real-world evidence
Describe principles of Good Publication Practice and evidence use
Construct a structured literature search for a scientific question
 

 

Course delivery method

Fully online, self-paced (asynchronous) on-demand learning. Participants may start at any time and complete the course at their own pace, within the specified course availability period. Pre-recorded lectures, interactive learning activities. 

 

Course pre-requisites

N/A

Additional course information

 

Aligned to MAPA Competency Framework.

Participants must successfully complete at least 80% of the program to be eligible for completion recognition. Progression through the content will be tracked, and participants will be required to submit a self-declaration at the conclusion of the program confirming that this completion threshold has been met. This declaration may be independently verified by the University if required. Upon successful completion of the program, participants will be issues with a Certificate of Completion from the University of Sydney.

 
  
Aligned with the MAPA Working Group   - Medical Affairs Competency Framework. 

Domain 1: Scientific and Technical Knowledge 
Domain 2: Evidence Generation 
Domain 3: Compliance and Ethics 
Domain 4: Leadership and Professionalism 
Domain 5: Communication and Collaboration 
Domain 6: Business Knowledge

If you're interested in the other courses, please click here.

For terms and conditions, please view here

 

Course fees
 Standard  $1,700
 Alumni/Staff  $1,530
You cannot proceed until you select 2 electives 

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