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First-in-Human (FIH) Clinical Trials Course & Certification
Intermediate
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4.7
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97% Recommended
Updated 2026
3 hours
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1 x First-in-Human (FIH) Clinical Trials
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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 the EMA FIH guideline (EMEA/CHMP/SWP/28367/07 Rev.1), FDA Phase I IND practice, MHRA Phase I accreditation, and current FIH safety practice, as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed by experienced clinical pharmacologists and Phase I unit leaders to ensure that learners can support FIH studies safely and competently.
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About
The First-in-Human (FIH) Clinical Trials Course is designed to provide a clear understanding of the design, planning, and execution of early-phase clinical studies conducted in humans for the first time. The course focuses on ensuring participant safety, scientific rigor, and regulatory compliance in early clinical development.
This course covers FIH study design, dose selection strategies, risk assessment, preclinical requirements, safety monitoring, escalation designs, regulatory expectations, and ethics considerations. It also emphasizes Good Clinical Practice (GCP) compliance, study oversight, and best practices for conducting safe and effective early-phase trials. Upon completion, learners receive a certification demonstrating competency in First-in-Human clinical trial concepts.
Who Should Enrol?
- Clinical Research Professionals
- Clinical Trial Managers and Coordinators
- Clinical Research Associates (CRAs)
- Principal Investigators and Sub-Investigators
- Regulatory Affairs Professionals
- Pharmacovigilance and Clinical Operations Teams
- Pharmaceutical and Biotechnology Industry Professionals
- Life Science, Pharmacy, Nursing, and Medical Graduates
What you will learn
Understand the fundamentals of First-in-Human (FIH) clinical trials, including their purpose, regulatory expectations, and translational science basis.
Learn key principles of dose selection, nonclinical data evaluation, study design, and safety assessment strategies for early-phase trials.
Gain knowledge of operational aspects such as investigational product control, clinical monitoring, safety oversight, and regulatory documentation requirements.
Develop an understanding of risk management, decision-making, audit readiness, and real-world case studies to support safe and compliant FIH trial execution.
Course Syllabus
- The drug development pipeline
- The risks and uncertainties of FIH
- Stakeholders and responsibilities
- Historic context - why we are careful
- Categories of FIH compounds
- Foundational concepts (preview)
- The FIH mindset
- Scenarios - thinking through FIH problems
- The regulatory map
- The EMA 2017 FIH guideline
- FDA expectations for Phase I INDs
- ICH guidelines that govern FIH
- EU CTR 536/2014 and CTIS
- Risk-based classification of FIH compounds
- Common regulator interactions and findings
- Scenarios - regulatory navigation
- The nonclinical pharmacology package
- The toxicology package
- Pharmacokinetics and ADME
- Pharmacodynamics and PK/PD modelling
- Safety pharmacology
- Special toxicology and supporting studies
- Translational science - bridging to humans
- Scenarios - translational decisions
- The dose-selection vocabulary
- NOAEL-based dose selection
- MABEL-based dose selection
- Special cases in dose selection
- From MRSD to escalation increments
- Common dose-selection errors
- Scenarios - dose selection decisions
- Identifying risks
- Safety margins
- Adverse events of special interest
- Risk mitigation
- The integrated safety strategy
- Real-time safety oversight
- Scenarios - safety strategy decisions
- Single Ascending Dose (SAD) design
- Multiple Ascending Dose (MAD) design
- Food-effect, DDI, and other integrated parts
- Integrated FIH protocols
- Sentinel dosing in detail
- Specialised designs
- Scenarios - design decisions
- Dosing-day operational discipline
- Adverse event monitoring
- Dose-escalation decisions
- Stopping rules
- Communication during conduct
- Real-world challenges
- Scenarios - clinical monitoring decisions
- The IMP supply chain
- Pharmacy operations at the Phase I unit
- Dose administration
- Dose-preparation errors
- Compliance checks
- Edge cases and complex compounds
- Scenarios - IMP and dosing decisions
- Identifying high-risk compounds
- The integrated risk-management framework
- Adaptive study design
- Risk escalation pathways
- Decision-making under uncertainty
- Crisis management
- Scenarios - risk management decisions
- The Investigator's Brochure
- The Clinical Trial Application (EU)
- The Investigational New Drug (US)
- The Trial Master File (TMF)
- The protocol
- Safety justification documentation
- Scenarios - documentation decisions
- Regulator inspection types
- MHRA Phase I-specific context
- FDA BIMO inspections
- Inspection findings - the patterns to know
- Internal audits
- Inspection readiness as continuous discipline
- Scenarios - inspection situations
- TGN1412 - 13 March 2006
- BIA 10-2474 - January 2016
- Dose miscalculation cases
- Lesser-known cases
- Compound-failure patterns
- Lessons learned and how to embed them
- Scenarios - applying historic lessons
- Course complete
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