Free guide

Data, AI & Real-World Evidence guide

Every Data, AI & Real-World Evidence program at Regulated Science Institute in one place: who each program is for, what you will learn and how long it takes.

2 programs
28 hours of study
PDF to keep

How to use this guide

Start with the program closest to your current role, then add the ones your next role asks for. Each entry below lists who the program is written for and the skills you leave with, so you can compare them side by side. Every program ends with a digital certificate of completion you can add to LinkedIn.

Real-World Evidence for Regulatory and Payer Decisions Professional Certificate

About 14 hours · online, self-paced · certificate

Who it is for

Data analysts, epidemiologists, clinical scientists, and medical affairs staff who generate or evaluate real-world evidence.

What you will learn

Judge whether a real-world data source is fit for purpose
Choose an appropriate RWE study design for a question
Identify and mitigate key sources of bias
Explain what FDA expects in RWE submissions
Communicate RWE results to regulators and payers

AI Governance in Drug and Device Development Professional Certificate

About 14 hours · online, self-paced · certificate

Who it is for

Regulatory, quality, data science, and digital health professionals who must deploy or evaluate AI in regulated life-science work.

What you will learn

Define the context of use and risk level for an AI model
Apply FDA's credibility assessment steps to a drug development use case
Outline a PCCP for an AI-enabled device
Determine EU AI Act obligations for a product or internal tool
Draft an AI governance policy for a GxP organization

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See the Data, AI & Real-World Evidence programs