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Clara Fargo
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I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
AI Bootcamp: Copilot for Clinical, Pharmacovigilance & Regulatory Teams Course & Certification
Intermediate
4.7
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97% Recommended
Updated 2026
3 hours
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Each course includes:
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 any changes to ICH E6(R3), EU CTR, 21 CFR Part 11, GVP Modules VI and IX,
ICH E2D/E2E, ICH E3, GxP and ALCOA+ data integrity principles, and the evolving guidance on AI in
regulated drafting and inspection — our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed by Whitehall Training in collaboration with practitioners across
clinical operations, pharmacovigilance, regulatory affairs and quality assurance, so that learners can
apply Copilot to real protocols, ICSRs, aggregate reports, LoQs, lay summaries, SOPs and inspection drills
on day one.
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About
The AI Bootcamp: Copilot for Clinical, Pharmacovigilance & Regulatory Teams Course & Certification is designed to provide hands-on exposure to AI-powered tools and copilots used in clinical research, drug safety, and regulatory operations. The course focuses on improving productivity, accuracy, and decision-making by leveraging AI-assisted workflows in regulated life sciences environments.
This bootcamp covers AI copilots for clinical trial operations, pharmacovigilance case processing, regulatory document generation, data summarization, and workflow automation. It also emphasizes responsible AI use, data privacy, compliance requirements, and real-world applications across clinical, safety, and regulatory functions. Upon successful completion, learners receive a certification demonstrating practical competency in AI copilot tools for life sciences.
Who Should Enrol ?:
- Clinical Research Professionals
- Pharmacovigilance and Drug Safety Teams
- Regulatory Affairs Professionals
- Medical Writers and Documentation Specialists
- Data Management and Clinical Operations Teams
- Pharmaceutical and Biotechnology Professionals
- AI/ML Beginners in Life Sciences
- Life Science, Pharmacy, Nursing, Medical, and Engineering Graduates
What you will learn
Understand the fundamentals of AI copilots in life sciences, including how they function as decision-support and productivity tools across clinical, pharmacovigilance, and regulatory workflows.
Learn how AI can be applied in clinical operations, protocol development, pharmacovigilance case processing, and drug safety activities to improve efficiency and accuracy.
Gain knowledge of AI-assisted regulatory and quality documentation processes, including structured content creation, review support, and compliance alignment.
Develop an understanding of advanced AI use cases such as agents, automated workflows, and scalable implementation strategies across clinical and regulatory teams.
Course Syllabus
- What makes a great prompt
- Before & after
- Prompt patterns that travel
- Iteration — where the value lives
- Guardrails in regulated work
- Your 90-minute practice plan
- Protocol design and review
- Feasibility and site selection
- Study start-up
- Monitoring and oversight
- Deviations and CAPAs
- Investigator communications
- Query management
- Meetings and minutes
- Risk-based monitoring
- Close-out and lessons learned
- Case intake & triage
- Narrative writing — CIOMS
- MedDRA coding support
- Signal detection — the prep work
- Signal validation & assessment
- Aggregate safety reports
- Literature surveillance
- Risk management plans
- Regulatory reporting
- Governance, audit & inspection
- Submission strategy
- Health authority question
- Clinical Study Report (CSR) writing
- Lay summaries
- SOPs and controlled documents
- Labels and product information
- Inspections and audits
- Document synthesis
- Regulatory intelligence
- Quality in an AI era
- What is an agent, really
- Agent recipes for clinical operations
- Agent recipes for pharmacovigilance
- Agent recipes for regulatory
- Loop as your team OS
- Measuring the value
- Team rollout and adoption
- Governance at scale
- The 12-month roadmap
- Practice exercise — 90-day plan, agent design, inspection self-check
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