ICH GCP E6(R3) PRACTICAL TRAINING

A modern, role-based training built for how clinical research actually works under R3

Learn ICH GCP E6(R3) the way FDA/EMA expect: through systems, risks, processes, and decisions

Shared theory

Role-specific practice

Skills you can immediately apply in your daily work

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WHY R3 MATTERS TODAY
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ICH GCP E6(R3) is not an update — it is a complete redesign of how quality is defined and achieved in clinical trials.

Regulators now expect:

✔ risk-based thinking
✔ management of Critical-to-Quality (CtQ) factors
✔ proportionality — controls matched to risk
✔ strong Sponsor, CRO and Site oversight
✔ ALCOA++ data & records integrity
✔ documented, defensible decision-making
Yet most professionals still operate in the E6(R2) mindset, resulting in:

✔ repeated findings
✔ weak oversight
✔ poor documentation logic
✔ unpredictable quality
✔ stress during audits and inspections

This training exists to bridge that gap and bring your skills to the R3 level.

WHAT THIS TRAINING IS ABOUT

A modern, practical R3 program built around:
- systems instead of checklists
- risks instead of tasks
- decisions instead of compliance anxiety
- role-specific practice instead of generic theory
Every participant receives:

✓ solid R3 theoretical foundation (QbD, Proportionality, RBQM, Oversight, ALCOA++)
✓ practice labs designed for their real role
✓ case studies based on FDA/EMA/The QARP findings
✓ assignments that simulate real clinical scenarios
✓ international certificate

WHAT CHANGED IN R3 — AND WHAT YOU WILL MASTER

Quality by Design (QbD)

Identify CtQ factors and build your processes around them.
Oversight as a system

Understand the responsibilities of Sponsors, CROs, Investigators, Vendors
Proportionality

Apply controls that match the true risk — stop over-monitoring or under-controlling.
Data & Records Integrity (ALCOA++)

Define source data, traceability, and manage digital systems correctly.
RBQM in practice

Build a Risk Register, QTLs, KRIs, escalation logic, and mitigation strategies
Evidence-based decision-making

Document decisions in a way that withstands an inspection

THE UNIQUE VALUE: ROLE-BASED PRACTICAL TRACKS

One theory.

Five different practical paths — tailored to how each role works in real life.

FOR INVESTIGATORS & SITE TEAMS

Practice labs:

• ICF errors & reconstruction
• identifying IPD + Root Cause + CAPA
• safety oversight scenarios
• Source Data reconstruction exercises
Outcomes:

• fewer deviations
• clearer documentation
• confident PI oversight
• inspection-ready behaviour

request the program

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FOR CRAs / SITE MANAGERS

Practice labs:

• remote monitoring drill
• identifying critical data deviations
• proper escalation and follow-up
• risk-based monitoring logic
Outcomes:

• fewer missed findings
• strong documentation trail
• confidence in remote & centralized monitoring
• alignment with RBQM expectations

request the program

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FOR PROJECT MANAGERS (CRO & SPONSOR)

Practice labs:

• building a Risk Register + QTLs
• Vendor Failure scenario (labs, imaging, data providers)
• Oversight File audit simulation
Outcomes:

• managing studies as risk-based systems
• predictable operational quality
• clean documentation for Sponsor oversight
• fewer escalations, smoother inspections

request the program

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FOR SPONSOR TEAMS

(Clinical, Data, Safety, Medical, PV)

Practice labs:

• decision-making on SAE, data discrepancies, protocol deviations
• mapping and assessing data flows
• Inspection Defense Simulation (EMA/FDA style)
Outcomes:

• confident regulatory decision-making
• strong data governance
• inspection-ready responses
• better cross-functional communication

request the program

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FOR QA, AUDITORS & COMPLIANCE PROFESSIONALS

Practice labs:

• auditing critical processes under R3
• RCA for complex deviations and issues
• classification challenge (minor/major/critical)
• reviewing oversight, TMF, vendor processes
Outcomes:

• conducting R3-level system audits
• identifying systemic failures, not symptoms
• building effective CAPA
• becoming an R3-competent audit expert

request the program

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WHAT YOU WILL DO DIFFERENTLY IN 30 DAYS

✔ think in systems, not tasks

✔ evaluate risks logically, not intuitively

✔ distinguish CtQ from noise

✔ document decisions like an inspector expects

✔ manage and monitor proportionally

✔ prevent deviations instead of closing them

✔ communicate professionally across roles

This is the skillset the industry now requires

WHY COMPANIES CHOOSE THIS TRAINING

Measurable quality improvement

Fewer findings → fewer delays → lower operational risk
Inspection readiness

Training content is directly aligned with EMA/FDA expectations
Team alignment

Everyone speaks one language: CtQ, risks, QTLs, ALCOA++, oversight
ROI in 1–2 studies

Better processes pay for themselves quickly

ABOUT THE TRAINER

Maxim Bunimovich

International GCP Auditor

• Conducted audits across EU & US regions
• Extensive experience with imaging vendors, Phase I units, central labs, CRO oversight
• Creator of the CSV training program for GCP auditors
• Over 500 audit findings analyzed and classified
• Works with Almirall, Menarini, AEMPS, Telix, EU-funded studies

A trainer who uses R3 every day — not someone who only teaches it.