Post-Marketing Studies and Real-World Evidence
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|---|---|---|---|---|
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About this course
Reasons to attend
In today's data-driven landscape, demonstrating the ongoing value, safety, and effectiveness of medicinal products doesn’t end at approval. This course is designed for pharmacovigilance professionals, lifecycle managers, affiliates, compliance officers, and local study leads who are involved in the post-authorisation phase.Participants will explore how to generate and leverage real-world evidence to meet country-specific regulatory obligations, support risk management, and fulfil post-approval commitments. Through practical examples and strategic insights, the course highlights how real-world data can power lifecycle success and sustained patient value.
What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course schedule
We provide this course in Classroom format.Classroom: 1-Day face-to-face: 09:00 - 17:00 |
Course Description
Once a medicinal product receives marketing authorisation, the journey is far from over. Increasingly, regulators, payers, and healthcare providers demand continued evidence of a product’s safety, effectiveness, and value in real-world use. This course provides a comprehensive overview of the strategic, operational, and regulatory aspects of post-marketing studies and real-world evidence (RWE) generation.Designed for professionals involved in lifecycle management, pharmacovigilance, compliance, and local study execution, the course explores how companies can fulfil post-approval commitments while generating insights that support decision-making across the product lifecycle. Participants will gain a clear understanding of the types and purposes of post-marketing studies (e.g. PASS, PAES), how to navigate evolving regulatory requirements across regions, and how to leverage real-world data to support safety monitoring, risk minimisation, and health technology assessments.
With a focus on practical application, the course will also cover how to design and manage post-authorisation studies effectively, engage stakeholders (including regulators and affiliates), and align evidence strategies with local and global obligations. Real-life examples and case studies will illustrate how RWE can be used not only to maintain compliance, but to demonstrate the continued value of medicines in diverse healthcare settings.
Whether you're new to post-marketing studies or looking to refine your RWE strategy, this course equips you with the knowledge and tools to confidently support product success after approval.
Programme highlight
- Overview of the role of post-marketing studies in lifecycle management
- Types of post-authorisation safety and effectiveness studies (PASS, PAES, registries, observational studies)
- Understanding real-world data sources and their practical limitations
- Navigating EU and international regulatory expectations for post-approval evidence
- Aligning post-marketing activities with risk management plans and local commitments
- Practical considerations for study design, implementation, and affiliate engagement
- Using real-world evidence to support safety, value, and access discussions
Learning objectives
By the end of this course, participants will:
- Describe the purpose and types of post-marketing studies and how they support regulatory and strategic goals
- Identify key regulatory requirements and local obligations for post-authorisation studies
- Understand the opportunities and constraints of real-world data in generating meaningful evidence
- Recognise how to align evidence generation activities with broader lifecycle and compliance strategies
- Apply practical principles to the planning and oversight of post-marketing studies
Who should attend
This course is ideal for professionals involved in post-approval activities and evidence generation, including:
- Pharmacovigilance specialists
- Lifecycle and product managers
- Local study leads and clinical operations staff
- Regulatory and compliance officers
- Medical affairs and affiliate team members
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design ()
- Ethical & Participants Safety Considerations ()
- Investigational Product Development and Regulation ()
- Clinical Studies Operations (GCPs or ISO 14155) ()
- Study and Site Management ()
- Data Management and Informatics ()
- Leadership and Professionalism ()
- Communication ()
- Teamwork ()
- Business acumen ()
Trainers
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