Professional training for the regulated life sciences
Regulated Science Institute offers 20 online programs for professionals at pharmaceutical, biotech and medical device companies, in six tracks from regulatory affairs to data, AI and real-world evidence. All programs are self-paced, with an audio version of each lesson. Every program ends with a certificate you can verify and add to LinkedIn.
Programs
Select a program to see who it is for and what it covers. Tick the ones you want, then enroll below.
Regulatory Affairs
5 programs
US Drug and Biologics Regulatory Pathways Professional Certificate
Written for scientists, clinicians, and project managers moving into regulatory affairs roles at drug and biologics sponsors or CROs.
US Medical Device Premarket Submissions Professional Certificate
Written for engineers, quality staff, and life-science graduates who want to prepare or support 510(k), De Novo, and PMA submissions.
EU MDR and IVDR Compliance Certificate Program
Written for regulatory, quality, and clinical professionals at device and diagnostics companies selling into the European Union.
CMC Regulatory Affairs Professional Certificate
Written for chemists, process engineers, and QA/QC staff who want to move into CMC regulatory roles.
Regulatory Operations and eCTD Submissions Certificate Program
Written for administrative, publishing, and documentation professionals seeking entry-level regulatory operations jobs.
Clinical Operations
4 programs
ICH E6(R3) Good Clinical Practice Implementation Professional Certificate
Written for clinical research coordinators, monitors, study managers, and sponsor staff who need to apply the revised GCP guideline in daily work.
Risk-Based Quality Management and Central Monitoring Professional Certificate
Written for clinical research associates, data managers, and study leads who want to move into central monitoring or RBQM roles.
Clinical Trial Project Management Professional Certificate
Written for CRAs, CRCs, and in-house clinical staff aiming for clinical trial manager or clinical project manager roles.
Decentralized and Hybrid Clinical Trials Certificate Program
Written for clinical operations staff, site staff, and digital health professionals who design or run trials with remote elements.
Quality & Compliance
5 programs
Drug Supply Chain Security and Traceability Certificate Program
Written for supply chain, distribution, pharmacy operations, and trade compliance staff at manufacturers, wholesalers, 3PLs, and dispensers.
Computer Software Assurance and Computerized System Validation Professional Certificate
Written for IT, QA, and validation engineers who need to validate GxP systems using modern risk-based methods.
GxP Data Integrity Professional Certificate
Written for QC analysts, QA reviewers, lab managers, and clinical data staff responsible for trustworthy GxP records.
Medical Device QMS: FDA QMSR and ISO 13485 Certificate Program
Written for quality engineers, QA specialists, and operations staff at medical device manufacturers and suppliers.
GMP Deviations, CAPA, and Inspection Readiness Professional Certificate
Written for manufacturing, QC, and QA staff who investigate deviations or prepare sites for regulatory inspections.
Drug Safety & Pharmacovigilance
2 programs
Drug Safety and ICSR Case Management Certificate Program
Written for life-science graduates, nurses, and pharmacy or healthcare professionals seeking entry-level drug safety associate roles.
Pharmacovigilance Signal Detection and Risk Management Professional Certificate
Written for drug safety associates and PV professionals ready to move into signal management, aggregate reporting, or PV scientist roles.
Market Access & HEOR
2 programs
US Market Access and Drug Pricing Policy Certificate Program
Written for commercial, medical, and policy professionals moving into market access, pricing, or trade relations roles.
HEOR and Health Technology Assessment Professional Certificate
Written for scientists, pharmacists, epidemiologists, and analysts who want to move into health economics and outcomes research or HTA roles.
Data, AI & Real-World Evidence
2 programs
Real-World Evidence for Regulatory and Payer Decisions Professional Certificate
Written for data analysts, epidemiologists, clinical scientists, and medical affairs staff who generate or evaluate real-world evidence.
AI Governance in Drug and Device Development Professional Certificate
Written for regulatory, quality, data science, and digital health professionals who must deploy or evaluate AI in regulated life-science work.
Training for your team
We offer group enrollment for companies, CROs and consultancies. If you want to train a team, email us with the programs you have in mind and roughly how many people would take them.
Free
A free guide for every track
Every program of a track in one guide: who each is for, what you will learn and how long it takes. Read it online or save it as a PDF.
Get a free guideQuestions
What is Regulated Science Institute?
Regulated Science Institute offers online, self-paced professional training in regulatory affairs, clinical operations, quality and compliance, drug safety and pharmacovigilance, market access and HEOR and data, AI and real-world evidence for people who work in the pharmaceutical, biotech and medical device industries.
Are the programs online?
Yes. Every program is online and self-paced, with an audio version of every lesson.
Do programs include a certificate?
Yes. When you finish every lesson of a program you receive a digital certificate of completion with a unique ID that anyone can verify, and you can add it to LinkedIn.
How do I enroll?
Open a program and select "Enroll". You pay securely by card, Apple Pay or Google Pay, and your account is ready as soon as the payment goes through.
How much do programs cost?
$395 per program, per person. Email support@regulatedscience.org for team pricing.
Can my company train a team?
Yes. Email support@regulatedscience.org with the programs and the size of your team.
Is there anything free?
Yes. Each track has a free guide, and you can see a sample certificate. Many programs also have a free practice quiz and a free first lesson.
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