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Medical Affairs: Evidence Generation

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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

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Course fees
Standard	$1,700
Alumni/Staff	$1,530

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Tutor/s

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Orin Chisholm View Profile
Matt Britland View Profile
David Carroll View Profile
Mahsa Kouhkamari View Profile

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Orin Chisholm Academic lead, Pharmaceutical and Medical Device Development programs Sydney Pharmacy School, Faculty of Medicine and Health Orin is the academic lead for the Pharmaceutical and Medical Device Development programs at the Sydney Pharmacy School, University of Sydney. In addition to her role in academia, she is a regulatory affairs consultant and an adjunct Associate Professor at UNSW Sydney, where she teaches global regulatory affairs leadership at Arizona State University, USA. Read More	True
Matt Britland Matthew Britland is a Medical Affairs leader with over 25 years of experience across clinical practice, the pharmaceutical industry, and academia. His expertise spans oncology, immunology, and rare diseases, with a focus on medical strategy, capability building, and patient outcomes. Currently completing a Doctor of Public Health at UNSW, his research explores Medical Affairs’ impact on the Quality Use of Medicines. A former MAPA President and MAPS APAC Steering Committee member, Matthew contributes to global best practices. He lectures at UNSW and USYD, mentoring future leaders and driving innovation through evidence-based healthcare and strategic collaboration. Read More	False
David Carroll David Carroll is a dedicated Learning and Capability Development specialist with over 25 years of experience in the pharmaceutical and biotechnology sectors. A passionate advocate for personal and professional growth, David believes that sustainable business success is built on strong foundations and a culture of continuous learning. Throughout his career, David has collaborated with leading global organisations including Johnson & Johnson, Novartis, AstraZeneca, AbbVie, and Eli Lilly. As a business leadership coach and capability development consultant, he designs and delivers impactful learning programs across commercial, medical affairs, management, and leadership domains. David’s work empowers individuals and teams to unlock their potential, drive performance, and foster innovation through strategic capability building. Read More	False
Mahsa Kouhkamari RWE leader and PhD-qualified scientist with 10+ years experience in observational research and real-world evidence generation. Passionate about teaching and translating data into impactful evidence. Read More	False

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