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  • Preclinical & Laboratory Foundations
  • Phase I – First-in-Human Trials
  • Phase II & III – Efficacy & Pivotal Trials
  • Clinical Trials Foundation PathNew
  • Regulatory Submission & Approval
Preclinical & Laboratory Foundations - courses at £199
  • Good Laboratory Practice (GLP)
  • 21 CFR Part 58 — Good Laboratory Practice (GLP) for Nonclinical Laboratories
  • OSHA Laboratory Safety Training
  • Laboratory Management Systems ISO/IEC 17025:2017
  • Computer System Validation - Validation, Data Integrity & Compliance (GAMP 5 & Annex 11)
  • Qualification Validation Training
  • Cleaning Validation
  • ISO 9001:2015 - Quality Management System for Pharmaceuticals

Author

Dr. Chirag Shah

Dr. Chirag Shah

Professor at the University of Washington (UW), Seattle, with research and teaching expertise in artificial intelligence, data science, machine learning, and search and recommender systems. A TEDx Speaker and ACM Distinguished Member.
Research focuses on task-based and conversational search and recommendation, user experience, multi-objective optimization, cold-start challenges, and agentic systems. Actively engaged in generative AI research, particularly in information access and image classification, with a strong emphasis on improving fairness and reducing bias in ML/AI systems.
Teaches undergraduate and graduate courses in Information Science and Data Science, and collaborates closely with leading industrial research labs as a visiting researcher. Recent industry engagements include Spotify, Amazon, Microsoft Research AI, Getty Images, and TikTok.
Has worked on real-world problems such as zero-intent and zero-query recommendations, marketplace fairness, and task-, journey-, and mission-based ranking systems, contributing to solutions and products that impact hundreds of millions of users across global markets.

About

The Module 1 – AI in Healthcare & Pharma: Foundations Course is designed to provide a clear introduction to the core concepts of artificial intelligence and its applications in healthcare, pharmaceuticals, and clinical research. The course focuses on building foundational knowledge of AI technologies and how they are transforming drug development, patient care, and healthcare operations.
This course covers AI fundamentals, machine learning concepts, data types in healthcare, real-world applications in clinical trials and drug discovery, regulatory and ethical considerations, and limitations of AI in life sciences. It also emphasizes responsible AI use, data privacy, and emerging trends shaping the future of healthcare innovation. Upon completion, learners receive a certification demonstrating foundational competency in AI for healthcare and pharma.

Who Should Enrol ?:

  • Clinical Research Professionals
  • Pharmaceutical and Biotechnology Professionals
  • Healthcare and Medical Professionals
  • Data Science and Analytics Beginners in Life Sciences
  • Regulatory Affairs and Compliance Professionals
  • Pharmacovigilance and Clinical Operations Teams
  • Life Science, Pharmacy, Nursing, and Medical Graduates

What you will learn

Understand the fundamentals of AI in healthcare and pharmaceuticals, including core concepts, use cases, and its role in modern clinical and operational environments.

Learn the principles of responsible AI implementation, including ethical considerations, governance expectations, and regulatory perspectives.

Gain knowledge of clinical validation approaches for AI systems, including performance evaluation, risk assessment, and lifecycle management.

Develop an understanding of post-market oversight, monitoring, and risk management of AI-enabled healthcare solutions to ensure safety, compliance, and reliability.

Course Syllabus

  1. Introduction & AI/ML Fundamentals
  2. Software Classification – US & EU Frameworks
  3. Design Controls & Quality Management
  4. AI-Specific Regulatory Considerations
  5. Documentation, Case Studies & Wrap-Up

  1. Introduction & Clinical AI Capabilities / Limitations
  2. Clinical Validation Requirements – US & EU
  3. Performance Monitoring & Post-Market Surveillance
  4. Risk Management & ISO 14971
  5. Case Studies & Documentation Checklist

Our Certified Customers

novartis
NHS
takeda
roche
baxter

Learner Rating & Reviews

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Frequently Asked Questions

  • Regulatory Affairs & Compliance Professionals
  • Clinical Research & Medical Affairs Teams
  • Quality Assurance & Quality Management Professionals
  • Digital Health, AI & Software Development Teams
  • Pharmaceutical & Medical Device Professionals
  • CROs, Sponsors, and Healthcare Innovators

This module builds the foundational understanding required to design and manage AI systems within regulated healthcare environments. This module focuses on clinical validation, performance monitoring, and risk management to ensure AI systems remain safe, effective, and compliant throughout their lifecycle.

  • Developed by regulatory and industry experts
  • Practical, real-world focus aligned with global regulatory expectations
  • Covers emerging AI regulatory guidance alongside established standards
  • Suitable for professionals across pharma, medical devices, and digital health
  • Designed to support audit readiness and compliant AI implementation