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Real World Evidence and Non Interventional Studies Course & Certification
Intermediate
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About
The Real World Evidence (RWE) and Non-Interventional Studies Course & Certification is designed to provide a practical understanding of how real-world data is generated, analyzed, and applied in clinical research and healthcare decision-making. The course focuses on generating evidence from routine clinical practice to support drug development, regulatory decisions, and post-marketing surveillance.
This course covers real-world data sources, study designs for non-interventional studies, observational research methods, bias and confounding, data analysis approaches, and regulatory expectations. It also emphasizes Good Pharmacoepidemiology Practice, study planning, and interpretation of real-world evidence in clinical and regulatory contexts. Upon successful completion, learners receive a certification demonstrating competency in RWE and non-interventional study methodologies.
Who Should Enrol ?:
- Clinical Research Professionals
- Pharmacovigilance and Drug Safety Teams
- Epidemiologists and Biostatistics Professionals
- Regulatory Affairs Professionals
- Medical Affairs and HEOR Teams
- Data Science and Analytics Professionals in Life Sciences
- Pharmaceutical and Biotechnology Employees
- Life Science, Pharmacy, Nursing, and Medical Graduates
What you will learn
Understand the fundamentals of Real-World Evidence (RWE) and non-interventional studies (NIS), including their role in clinical research and healthcare decision-making.
Learn key regulatory expectations, ethical principles, and data protection requirements governing RWE generation and non-interventional study conduct.
Gain knowledge of study design, operational execution, data collection, quality assurance, and pharmacovigilance considerations in NIS.
Develop an understanding of analysis, interpretation, regulatory use of RWE, common challenges, and future trends including AI-driven insights in real-world research.
Course Syllabus
- Foundations of Real-World Evidence
- Global regulatory perspective
- Decision-making with RWE
- Common pitfalls and how to avoid them
- A practical decision tool
- Bringing it together
- Defining non-interventional studies
- The NIS study type family
- Choosing and defending a design
- Common mistakes and pitfalls
- Bringing it together
- The global regulatory map
- The EU framework
- The FDA framework
- MHRA and other jurisdictions
- Practical workflows
- Pitfalls, case study and checks
- Bringing it together
- Ethical foundations
- Consent models
- GDPR and data protection
- International context
- Operational excellence
- Case study and knowledge checks
- Bringing it together
- Design decision framework
- Biases and how to control them
- Sample size, endpoints and SAP
- Pitfalls, case study, checks
- Bringing it together
- The RWD data universe
- Common data models
- Relevance, reliability and quality
- Quality assurance in practice
- Case, checks, takeaways
- Bringing it together
- NIS inside pharmacovigilance
- PASS in depth
- Active surveillance and modern PV
- Benefit-risk and RMPs
- Pitfalls, case and checks
- Bringing it together
- Governance and team
- Sites, vendors and data
- Documentation and change
- Quality and inspection
- Case and checks
- Bringing it together
- Reading RWE with discipline
- From significance to meaning
- Interpretation for audiences
- Pitfalls, case, checks
- Bringing it together
- Regulator-accepted use cases
- Anatomy of acceptance
- Post-marketing and lifecycle
- Scientific advice — strategic use
- Cases — success and failure
- Bringing it together
- The four pillars of failure
- Design failures — five classics
- Data failures — four classics and honest data humility
- Analysis failures — four classics
- Communication failures
- Anonymised failure cases
- Credibility recovery
- The technology stack of 2030
- Digital health data
- Federated analytics & real-time evidence
- AI governance
- Course synthesis
Course Benefits
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with FDA RWE guidance series, EMA GVP Module VIII, the EMA DARWIN EU programme, MHRA RWD guidance series, PMDA, Health Canada and TGA expectations, GDPR and international data-transfer rules, and the emerging AI governance frameworks (TEBPAH). Our training courses are constantly monitored, reviewed and updated as guidance evolves.
Learn from Industry Experts
The course content has been developed by senior practitioners across pharmacovigilance, regulatory affairs, epidemiology and HEOR with 35+ years of cumulative SME experience. Every module integrates anonymised case studies, decision tools and Whitehall-developed playbooks (the RWE readiness checklist, the data-source selection guide, the NIS design brief, the acceptance matrix, and the TEBPAH AI governance framework) so learners can move directly from concept to application.
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