Buy the GCP R3 course & get a FREE eBook— your complete ICH-GCP R3 reference guide. Book Now →

  • AI ClinicalAI ClinicalNewRight Arrow
  • Clinical PracticeClinical PracticeRight Arrow
  • PharmacovigilancePharmacovigilanceRight Arrow
  • ManufacturingManufacturingRight Arrow
  • Laboratory PracticeLaboratory PracticeRight Arrow
  • DistributionDistributionRight Arrow
  • Medical DevicesMedical DevicesRight Arrow
  • Regulatory AffairsRegulatory AffairsRight Arrow
  • Research ComplianceResearch ComplianceRight Arrow
  • Health & SafetyHealth & SafetyRight Arrow
  • Quality AssuranceQuality AssuranceRight Arrow
  • BiostatisticsBiostatisticsTrendingRight Arrow
  • Pharmaceutical MedicinePharmaceutical MedicineNewRight Arrow
  • All Bundles
  • Clinical Trials Development
  • GCP & GxP Standards
  • GMP & Quality Assurance
  • Pharmacovigilance
  • Role Based
  • Distribution
  • Medical Devices
  • Medical Writing
  • AI Clinical
  • Quality Assurance
  • Customize your bundleBuild your own path
View all 28 learning paths
  • Preclinical & Laboratory Foundations Learning Path
  • Phase I – First-in-Human Trials Learning Path
  • Phase II & III – Efficacy & Pivotal Trials Learning Path
  • Clinical Trials Foundation PathNew
  • Regulatory Submission & Approval
Preclinical & Laboratory Foundations Learning Path - courses at £199

About

Clinical drug development is a structured process in which evidence on safety, tolerability, efficacy, and benefit-risk is generated progressively across different stages of clinical research. Each phase has distinct objectives, study designs, populations, and decision points that contribute to determining whether a medicine can progress toward regulatory approval and continued evaluation after marketing.
This Pharmaceutical Medicine – Clinical Phases of Drug Development Training Course & Certification provides comprehensive knowledge of preclinical development and the transition to first-in-human studies, Phase I, Phase II, Phase III, regulatory submission and approval, Phase IV post-marketing studies, development attrition, and go/no-go decisions across the clinical development lifecycle. Upon successful completion, learners receive a certification demonstrating their understanding of clinical development phases and the principles that guide pharmaceutical development and regulatory decision-making.

Who Should Enrol?

  • Clinical Research and Clinical Operations Professionals
  • Clinical Trial Managers and Clinical Research Associates
  • Pharmaceutical Medicine and Medical Affairs Professionals
  • Drug Development and Clinical Development Teams
  • Regulatory Affairs and Compliance Professionals
  • Biostatistics and Clinical Data Management Professionals
  • Pharmacovigilance and Drug Safety Professionals
  • Anyone seeking to understand the clinical phases, decision-making, and regulatory pathway of drug development
📢 Every purchase also includes our FREE companion Clinical Phases of Drug Development eBook, designed to help you apply principles in real-world pharmaceutical medicine settings.

What you will learn

Understand the progression of drug development from preclinical research through clinical development, regulatory submission, approval, and post-marketing evaluation.

Learn the objectives, study designs, participants, endpoints, safety considerations, and regulatory expectations associated with Phase I, Phase II, Phase III, and Phase IV clinical development.

Develop knowledge of first-in-human studies, dose selection, proof-of-concept development, confirmatory trials, benefit-risk assessment, and the evidence required to support regulatory decisions.

Gain practical understanding of clinical development decision points, development attrition, go/no-go decisions, regulatory interactions, and the transition from clinical development to post-marketing surveillance.

Course Syllabus

  1. A. Drug discovery and lead optimisation
  2. What 'preclinical' means and where it sits
  3. The funnel: from thousands of compounds to one lead
  4. Drug discovery: choosing a target
  5. target -> hit -> lead -> candidate
  6. What lead optimisation tunes
  7. How compounds are screened, in plain terms
  8. veltarib is selected as the lead
  9. B. What the nonclinical package must show
  10. The three questions the package answers
  11. Three kinds of pharmacology
  12. Primary pharmacology: does it work?
  13. Secondary and safety pharmacology
  14. The safety pharmacology core battery
  15. PK/ADME in plain terms
  16. Half-life and why it matters
  17. veltarib's PK profile at a glance
  18. C. GLP toxicology and the NOAEL
  19. What GLP means
  20. Repeat-dose toxicology in two species
  21. Why two species are required
  22. Other toxicology studies
  23. What a toxicology study measures
  24. The NOAEL defined
  25. veltarib's NOAEL, illustratively
  26. D. From NOAEL to a safe human starting dose
  27. Why we cannot just use the animal dose
  28. Step 1 - NOAEL to Human Equivalent Dose
  29. Step 2 - apply a safety factor
  30. Step 3 - the Maximum Recommended Starting Dose
  31. The whole chain on one card
  32. What can change the safety factor
  33. E. The IND / CTA and ICH M3(R2)
  34. From package to permission to dose
  35. What an IND is
  36. What the IND contains
  37. The CTA in the EU and UK
  38. ICH M3(R2) sets the expectations
  39. The review and the clinical hold
  40. The go decision to enter humans
  41. F. Small molecules vs biologics - and where the science lives
  42. Two modalities, two packages
  43. Species selection for biologics
  44. Immunogenicity - a biologic concern
  45. MABEL instead of NOAEL
  46. Where the deep science lives
  47. G. Worked example - veltarib from screen to first human dose
  48. Worked example, part 1 - screen to IND-enabling package
  49. Worked example, part 2 - NOAEL to a first human dose
  50. Worked example, part 3 - the go decision
  51. Preclinical timeline at a glance
  52. Common preclinical pitfalls
  53. Scope and boundary note

  1. A. What Phase I is actually for
  2. The four jobs of a Phase I programme
  3. Phase I is NOT a test of efficacy
  4. Pharmacokinetics: what the body does to the drug
  5. Pharmacodynamics: what the drug does to the body
  6. Phase I at a glance
  7. Key PK measures in plain English
  8. The healthy-volunteer setting
  9. B. Who receives the first doses
  10. Why healthy volunteers are the default
  11. When patients are dosed first
  12. novaxamab: the biologic contrast
  13. Why risk drives the setting
  14. Consent, oversight and payment
  15. C. SAD and MAD dose-escalation designs
  16. Single Ascending Dose (SAD)
  17. Multiple Ascending Dose (MAD)
  18. SAD vs MAD — how they differ
  19. The cohort: about eight subjects
  20. Six active, two placebo
  21. Sentinel and staggered dosing
  22. Blinding and placebo control
  23. D. Escalation rules, DLT, MTD and 3+3
  24. Pre-defined escalation rules
  25. Pre-defined stopping rules
  26. Dose-limiting toxicity (DLT)
  27. Maximum tolerated dose (MTD)
  28. The 3+3 design (oncology), conceptually
  29. A simple escalation-step illustration
  30. Who decides to escalate?
  31. E. Other Phase I (clinical pharmacology) studies
  32. Food-effect studies
  33. Drug-drug interaction studies
  34. Bioavailability
  35. Special-population studies
  36. Why this all sits in Phase I
  37. F. First-in-human safeguards and hard lessons
  38. First-in-human is inherently uncertain
  39. TGN1412 (2006): what happened
  40. The lessons: sentinel and staggered dosing
  41. MABEL: a more cautious starting dose
  42. FDA and EMA first-in-human guidance
  43. G. veltarib's Phase I — and what it hands on
  44. Adaptive first-in-human designs
  45. Worked example — veltarib SAD escalation
  46. Worked example — veltarib MAD and the go decision
  47. What a Phase I package delivers
  48. The handover into Phase II
  49. Where trial design and statistics live
  50. Common Phase I misunderstandings

  1. A. What Phase II is for
  2. The one question Phase II answers
  3. Where Phase II sits in the journey
  4. Two halves: Phase IIa and Phase IIb
  5. What Phase II is NOT
  6. What Phase II must deliver into Phase III
  7. Where Phase II fits the four questions
  8. B. Moving into the target patients
  9. Why Phase II needs real patients
  10. veltarib's target population
  11. Inclusion and exclusion — conceptually
  12. What changes when you dose patients
  13. Consent and ethics in the patient setting
  14. C. Phase IIa — proof of concept
  15. What 'proof of concept' means
  16. veltarib's IIa question
  17. Typical IIa size and duration
  18. Reading a proof-of-concept signal
  19. When proof of concept fails
  20. D. Endpoints, control and blinding
  21. Choosing a Phase II endpoint
  22. Biomarkers and surrogate endpoints
  23. Why use a surrogate in Phase II
  24. The control group: placebo or active
  25. Randomisation — conceptually
  26. Blinding — conceptually
  27. Where the design science lives
  28. E. Phase IIb — dose-finding
  29. The IIb question: which dose?
  30. The dose-arm design
  31. The dose-response relationship
  32. veltarib's dose-response, illustrated
  33. Picking the Phase III dose
  34. Too little, too much: the dosing risks
  35. Worked example (1 of 2): veltarib Phase IIa proof of concept
  36. Worked example (2 of 2): veltarib IIb dose-finding -> the Phase III dose
  37. F. Size, duration & the graveyard
  38. Typical Phase II sizes and durations
  39. Phase II in the escalating scale
  40. Why Phase II is the graveyard
  41. Fail-fast: why the graveyard is good
  42. Attrition across the phases
  43. G. The go/no-go decision
  44. The go/no-go-to-Phase-III gate
  45. The go/no-go criteria
  46. Adaptive and seamless II/III designs
  47. Phase II in one picture
  48. Phase II — key takeaways

  1. A. What Phase III is for
  2. Confirm, don't explore
  3. The intended-use population
  4. Efficacy and safety, together
  5. Where Phase III sits in the journey
  6. The questions Phase III must answer
  7. B. What makes a trial 'pivotal'
  8. What 'pivotal' means
  9. Adequate and well-controlled
  10. Substantial evidence: the two-trial idea
  11. When one trial can be enough
  12. Randomisation and blinding
  13. Superiority and non-inferiority
  14. Bias — the enemy Phase III fights
  15. C. Scale, duration and the safety database
  16. How big and how long
  17. The safety database
  18. ICH E1 exposure expectations
  19. Why about a year of treatment?
  20. Building the pooled safety database
  21. D. Endpoints and comparators
  22. Primary vs key secondary endpoints
  23. Choosing the comparator
  24. Surrogate and clinical endpoints
  25. The endpoint hierarchy
  26. Pre-specification and the analysis plan
  27. E. Global development — multi-regional trials
  28. What a multi-regional trial is
  29. ICH E17 — keeping it consistent
  30. Regional regulatory acceptance
  31. Intrinsic and extrinsic regional factors
  32. Why global development is the norm
  33. F. Running the trial well
  34. Data Monitoring Committees
  35. Interim looks — handle with care
  36. Special populations and subgroups
  37. Adherence, retention and data quality
  38. Adjudicating key clinical events
  39. G. VELOCITY-1 & VELOCITY-2 — design intent
  40. VELOCITY-1 & VELOCITY-2 — the design intent
  41. Why TWO pivotal trials — and a CV programme
  42. What can still go wrong in Phase III
  43. Phase III success is not guaranteed
  44. The output that feeds the submission
  45. The cardiovascular-safety programme
  46. Reading the VELOCITY read-out
  47. From last patient to database lock
  48. H. Where the deeper science lives
  49. Downstream course map for Phase III
  50. Phase III in one picture
  51. Common misunderstandings

  1. A. From last patient to a marketing application
  2. Last-patient-last-visit is a milestone, not the finish
  3. What a marketing application actually asks
  4. One medicine, several regulators
  5. The submission-to-approval timeline at a glance
  6. Before you can file: the pre-conditions
  7. B. The US routes — NDA vs BLA
  8. The NDA — veltarib's route (21 CFR 314)
  9. The BLA — novaxamab's route (21 CFR 601)
  10. Why NDA versus BLA actually matters
  11. User fees fund a predictable review
  12. Filing versus refuse-to-file
  13. C. The EU route — the MAA and the centralised procedure
  14. The MAA and the four EU routes
  15. The centralised procedure to EMA and CHMP
  16. Who does the work — CHMP rapporteurs
  17. The EU 210-day clock and clock-stops
  18. The UK / MHRA route, briefly
  19. D. The dossier — CTD and eCTD (ICH M4)
  20. The CTD — one structure, five modules
  21. Module 1 — regional administrative
  22. Modules 2 and 3 — summaries and quality
  23. Modules 4 and 5 — nonclinical and clinical
  24. The eCTD — the electronic dossier
  25. E. Talking to the regulator before you file
  26. Meet early, meet often
  27. The pre-NDA / pre-BLA meeting
  28. EU scientific advice and protocol assistance
  29. Advisory committees
  30. F. The review process and timelines
  31. The FDA review clock and PDUFA goal dates
  32. Standard versus priority review
  33. Rolling review — starting before the dossier is complete
  34. The review is a team of disciplines
  35. The EMA clock — Day 120 and Day 180 questions
  36. From CHMP opinion to European Commission decision
  37. When the review finds a serious problem
  38. FDA and EMA reviews side by side
  39. G. Labelling, expedited pathways and approval
  40. The label — the US Prescribing Information
  41. The label — the EU SmPC
  42. Expedited pathways — the idea
  43. US expedited pathways
  44. EU expedited pathways
  45. Approval is not the last submission
  46. Approval — and the handover to Phase IV
  47. Where the deeper detail lives
  48. Worked example — same evidence, three routes
  49. Worked example — veltarib through the FDA clock to approval

  1. A. Approval is not the finish line
  2. What Phase IV actually is
  3. Why approval is not the finish line
  4. What the trials could not tell us
  5. The real world is bigger, longer and messier
  6. From launch to lifecycle surveillance
  7. Who does the Phase IV work
  8. B. Requirements, commitments and post-authorisation studies
  9. Two kinds of obligation
  10. US post-marketing requirements (PMRs)
  11. US post-marketing commitments (PMCs)
  12. Requirements versus commitments at a glance
  13. The EU view: post-authorisation measures
  14. PASS: post-authorisation safety studies
  15. PAES: post-authorisation efficacy studies
  16. C. Outcomes trials — the veltarib CVOT
  17. What an outcomes trial is
  18. Surrogate markers versus real outcomes
  19. Why diabetes drugs face a CV expectation
  20. Reading a CVOT result in plain English
  21. How the CVOT feeds back into the label
  22. D. Real-world evidence and real-world data
  23. Where real-world data comes from
  24. From data to evidence
  25. What real-world evidence is good for
  26. The limits: confounding and data quality
  27. Real-world evidence versus randomised trials
  28. RWE complements — it does not replace trials
  29. E. The pharmacovigilance link
  30. What pharmacovigilance is and why it matters
  31. Spontaneous reports and ICSRs
  32. Who reports, and the company's duty
  33. Signal detection: spotting a new risk
  34. The pharmacovigilance loop
  35. The PSUR / PBRER periodic report
  36. Managing risk: RMP (EU) versus REMS (US)
  37. Benefit-risk over the whole lifecycle
  38. F. Lifecycle management
  39. What lifecycle management means
  40. Label expansions and new indications
  41. New formulations and new dosing
  42. New populations, including children
  43. Paediatric investigation plans
  44. End of lifecycle: generics and biosimilars
  45. G. Worked example — veltarib after launch
  46. veltarib’s post-marketing journey, step by step
  47. What the worked example teaches

  1. A. Development is mostly failure — by design
  2. The uncomfortable truth about the pipeline
  3. What 'attrition' actually means
  4. Attrition is designed in, not an accident
  5. Where compounds are lost
  6. The cost of getting the decision wrong
  7. B. The attrition funnel & odds by phase
  8. The funnel across the phases
  9. Likelihood of approval by phase
  10. Phase II — the biggest single drop
  11. The overall odds from Phase I
  12. Reading the declining survival curve
  13. A word on the figures
  14. C. Why drugs fail
  15. Four families of failure
  16. Efficacy — the number one killer
  17. Safety failures
  18. PK, commercial and strategic failure
  19. The reasons shift phase by phase
  20. D. Go/No-Go decision gates
  21. What a go/no-go gate is
  22. The gates across the pathway
  23. Criteria at each gate
  24. The go/no-go decision, as simple logic
  25. The target product profile — the yardstick
  26. veltarib's target product profile
  27. Who sits on a go/no-go board
  28. E. Portfolio thinking & fail-fast economics
  29. Kill early, fail fast
  30. The economics of late failure
  31. The sunk-cost trap
  32. Managing a portfolio, not one drug
  33. How a go/no-go board actually decides
  34. Worked example — veltarib's end-of-Phase-II board
  35. F. The downstream-course map
  36. This course is the spine, not the whole skeleton
  37. The course map
  38. The map as a hub
  39. Preclinical science -> Pharmacology & Toxicology
  40. Trial structure -> Clinical Trial Design
  41. Endpoints -> Endpoints in Clinical Trials
  42. Sizing & analysis -> the Biostatistics courses
  43. The sibling spine -> Intro to Pharmaceutical Medicine
  44. This course does not duplicate the others
  45. The whole map on one line for veltarib
  46. G. Putting it to work
  47. Reading the funnel like a practitioner
  48. Using the map in your role

  1. 📘 Bonus: Clinical Phases of Drug Development eBook (Free with purchase)

Course Benefits

Benefits ebook icon
Free eBook

Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever

Benefits cpd_points icon
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.

Benefits certification icon
Certification

Receive a personal certificate to show your subject knowledge on course completion.

Benefits affordable icon
Affordable

You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.

Benefits flexible icon
Flexibility

The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.

Benefits up_to_date icon
Keep Up to Date

You will stay up to date with any changes to ICH E9 (Statistical Principles for Clinical Trials), ICH E9(R1) (estimands and sensitivity analysis), ICH E3 (clinical study reports) and CONSORT 2010 reporting standards for time-to-event endpoints, as our training courses are constantly monitored, reviewed and updated.

Benefits industry_experts icon
Learn from Industry Experts

The course content has been developed by practitioners in oncology and clinical-trial biostatistics to ensure that learners can read a Kaplan-Meier curve and a forest plot, interpret a hazard ratio, and report a survival analysis that will withstand regulatory and peer review.


Our Certified Customers

novartis
NHS
takeda
roche
dhl

Learner Rating & Reviews

4.7
★★★★★★
Average Rating
536 global ratings
★★★★★
87.0%
★★★★★
5.0%
★★★★★
3.0%
★★★★★
3.0%
★★★★★
2.0%
RC

Working with Whitehall training for the last two years of partnership has been a very successful experience – I have fast access to all the GCP course...

SM

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...

Recommended Courses

General Pharmacology

General Pharmacology

Intermediate
£393 hrs3 points
Introduction to Pharmaceutical Medicine

Introduction to Pharmaceutical Medicine

Intermediate
£393 hrs3 points
Qualified Person Responsibilities, Batch Certification and Batch Release

Qualified Person Responsibilities, Batch Certification and Batch Release

Intermediate
£393 hrs3 points
Clinical Operations Specialist

Clinical Operations Specialist

Intermediate
£393 hrs2 points
SAS Programming for Clinical Trials

SAS Programming for Clinical Trials

Intermediate
£393 hrs3 points