Description

A focused course, tailored for you

Building Modern Pharma GRC and Compliance Integration (FDA + EMA + Swissmedic + PMDA + NMPA + GxP + Data Integrity + AI Compliance + Pharmacovigilance + Engagement)

Build the modern pharma GRC and compliance integration capability in 10 weeks. FDA + EMA + Swissmedic + PMDA + NMPA + GxP + data integrity + AI compliance + pharmacovigilance + engagement.

Pharma GRC leaders at global pharma face multi-jurisdiction compliance complexity: FDA + EMA + Swissmedic + PMDA + NMPA + GxP + data integrity + AI compliance + pharmacovigilance. Leaders who build the modern capability take the senior global compliance work. Here is the 10-week build.

$199 one-time

Tailored to your situation. Access within 24 hours. 30-day money-back.

Includes a hand-built implementation playbook delivered alongside course access, generated for your specific situation.

Why this course

Pharma GRC and compliance leaders (Roche, Novartis, Sanofi, GSK, AstraZeneca, Bayer, Boehringer Ingelheim, Merck KGaA, Pfizer, Johnson & Johnson, Lilly, Bristol-Myers Squibb, AbbVie, Amgen, Gilead, Vertex, Biogen, Regeneron, Moderna, BioNTech, CureVac, Recursion, Insmed, Alnylam, Intellia, Editas, Beam Therapeutics, Verve Therapeutics, BeiGene, Daiichi Sankyo, Takeda, Eisai, Otsuka, Astellas, Mitsubishi Tanabe, Kyowa Kirin, Shionogi, Sumitomo Pharma, Chugai Roche-anchored, ONO Pharmaceutical, JCR Pharmaceuticals, BeOne Medicines BeiGene, Innovent Biologics, Junshi Biosciences, Kymera Therapeutics, Bicara Therapeutics, Mirati Therapeutics, Foghorn Therapeutics, Cellectis, Affimed, ChemoCentryx, Arrowhead Pharmaceuticals, Ionis Pharmaceuticals, Sarepta Therapeutics, Travere Therapeutics, Insmed, NextWave Pharma, NextWave Pharma, Solid Biosciences, RegenxBio, Sangamo Therapeutics, BridgeBio Pharma, Apellis Pharmaceuticals, Aldeyra Therapeutics, Cytokinetics, Geron, Mersana Therapeutics, Y-mAbs Therapeutics, Imago BioSciences) face multi-jurisdiction compliance complexity in 2024-2026.

Multi-jurisdiction regulatory landscape: FDA + EMA + Swissmedic + PMDA + NMPA + MFDS + TGA + CDSCO + ANVISA + COFEPRIS + Health Canada + MHRA + Saudi SFDA + UAE Ministry of Health + Singapore HSA + Israel Ministry of Health + Russia Roszdravnadzor + Ukraine SMA. GxP compliance (GMP, GLP, GCP, GDP, GVP, GAMP 5 Second Edition for computer-system validation), data integrity (FDA ALCOA+ principles, EU GMP Annex 11 update, PIC/S PI 041, WHO data integrity guidance), AI compliance (FDA AI/ML SaMD Action Plan, FDA PCCP guidance, EU AI Act for AI medical devices and high-risk AI, EU Annex 22 draft AI in GMP, IMDRF SaMD, NIST AI RMF), pharmacovigilance (PV system master file, individual case safety reports, periodic safety update reports, EU EudraVigilance, FDA FAERS, Japan PMDA's Risk Manager Plan, China NMPA Adverse Drug Reaction reporting, multi-jurisdiction signal detection), drug supply chain transparency (DSCSA US fully effective 2025, EU FMD), serialisation framework, anti-counterfeiting framework, trial transparency (ClinicalTrials.gov + EudraCT + EMA Clinical Trials Information System), anti-corruption (FCPA + UK Bribery Act + China Anti-Unfair Competition Law + Brazil Clean Companies Act + AKO Act in Italy), and engagement economics for global pharma scale all need to land at the compliance leader layer.

Leaders who build the modern capability take the senior global compliance work. Leaders who stay on classic single-jurisdiction compliance-only patterns watch the senior work shift to peers.

This course teaches the 10-week build of modern pharma GRC and compliance integration: multi-jurisdiction framework, GxP framework, data integrity framework, AI compliance framework, pharmacovigilance framework, supply chain framework, trial transparency framework, anti-corruption framework, and the executive engagement model. Twelve modules with deliverables. Plus a hand-built implementation playbook for your specific operation.

What you walk away with

A documented multi-jurisdiction framework.
A GxP framework.
A data integrity framework.
An AI compliance framework.
A pharmacovigilance framework.
A supply chain framework.
A trial transparency framework.
An anti-corruption framework.
An executive engagement model.
A 10-week build plan.

The 12 modules

Module 1. Pharma GRC landscape 2026

Detailed walkthrough of the pharma GRC landscape in 2026: peer-firm positioning at Roche + Novartis + Sanofi + GSK + AstraZeneca + Bayer + Boehringer Ingelheim + Merck KGaA + Pfizer + Johnson & Johnson + Lilly + Bristol-Myers Squibb + AbbVie + Amgen + Gilead + Vertex + Biogen + Regeneron + Moderna + BioNTech + CureVac + Recursion + Insmed + Alnylam + Intellia + Editas + Beam Therapeutics + Verve Therapeutics + BeiGene + Daiichi Sankyo + Takeda + Eisai + Otsuka + Astellas + Mitsubishi Tanabe + Kyowa Kirin + Shionogi + Sumitomo Pharma + Chugai + ONO Pharmaceutical + JCR Pharmaceuticals, regulatory landscape (FDA + EMA + Swissmedic + PMDA + NMPA + MFDS + TGA + CDSCO + ANVISA + COFEPRIS + Health Canada + MHRA + Saudi SFDA + UAE Ministry of Health + Singapore HSA + Israel Ministry of Health), and the strategic-level decisions facing compliance leaders.

Module 2. Multi-jurisdiction framework

Build the multi-jurisdiction framework: FDA framework, EMA framework, Swissmedic framework, PMDA framework, NMPA framework, MFDS framework, TGA framework, CDSCO framework, ANVISA framework, COFEPRIS framework, Health Canada framework, MHRA framework, Saudi SFDA framework, UAE Ministry of Health framework, Singapore HSA framework, Israel Ministry of Health framework, regulatory-harmonisation framework (IMDRF, ICH), and the integration with broader regulatory affairs.

Module 3. GxP framework

Build the GxP framework: GMP framework (FDA 21 CFR 211, EU GMP, PIC/S, WHO TRS 1019), GLP framework, GCP framework (ICH E6 R3, FDA, EMA, PMDA), GDP framework, GVP framework, GAMP 5 Second Edition computer-system validation framework, GxP-supplier framework, and the integration with broader quality strategy.

Module 4. Data integrity framework

Build the data integrity framework: ALCOA+ principles framework (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available), electronic-record framework (FDA 21 CFR Part 11, EU GMP Annex 11), audit-trail framework, exception-management framework, data-lifecycle framework, PIC/S PI 041 alignment framework, WHO data integrity guidance alignment framework, and the integration with broader compliance.

Module 5. AI compliance framework

Build the AI compliance framework: FDA AI/ML SaMD Action Plan integration framework, FDA PCCP (Predetermined Change Control Plan) framework, EU AI Act application framework (high-risk Annex III for AI medical devices + EU Annex 22 draft AI in GMP), IMDRF SaMD framework, NIST AI RMF integration framework, AI vendor due-diligence framework, AI model lifecycle management framework, and the integration with broader AI strategy.

Module 6. Pharmacovigilance framework

Build the pharmacovigilance framework: PV system master file framework, individual case safety reports framework, periodic safety update reports framework, EU EudraVigilance integration framework, FDA FAERS integration framework, Japan PMDA's Risk Manager Plan framework, China NMPA Adverse Drug Reaction reporting framework, multi-jurisdiction signal detection framework, risk minimisation measures framework, and the integration with broader safety strategy.

Module 7. Supply chain framework

Build the supply chain framework: DSCSA US (fully effective 2025) framework, EU FMD framework, serialisation framework, anti-counterfeiting framework, cold-chain framework, supply-chain transparency framework, and the integration with broader supply-chain strategy.

Module 8. Trial transparency framework

Build the trial transparency framework: ClinicalTrials.gov framework, EudraCT framework, EMA Clinical Trials Information System framework, FDAAA 801 framework, EU Clinical Trials Regulation 536/2014 framework, results-disclosure framework, lay-summary framework, plain-language-summary framework, and the integration with broader transparency.

Module 9. Anti-corruption framework

Build the anti-corruption framework: FCPA framework, UK Bribery Act framework, China Anti-Unfair Competition Law framework, Brazil Clean Companies Act framework, AKO Act framework (Italy), Mexico Federal Law on Public Contracts framework, India Prevention of Corruption Act framework, Japan Unfair Competition Prevention Act framework, sales-rep-and-physician interaction framework, transparency reporting framework (US Physician Payments Sunshine Act, EU EFPIA Transparency Initiative), and the integration with broader compliance.

Module 10. Engagement framework

Build the engagement framework: customer-CEO engagement framework, customer-CCO engagement framework, customer-CQO engagement framework, customer-Chief-Regulatory-Affairs-Officer engagement framework, customer-Chief-Safety-Officer engagement framework, customer-CMO engagement framework, customer-Board-Audit-Committee engagement framework, and the integration with broader executive engagement.

Module 11. Technology stack framework

Build the technology stack framework: GRC platform selection (ServiceNow GRC, OneTrust, MetricStream, RSA Archer, IBM OpenPages, Riskonnect, Galvanize Diligent legacy, AuditBoard, Workiva, in-house), QMS platform selection (Veeva Vault QMS, MasterControl, Pilgrim Quality Solutions, Sparta Systems TrackWise, ETQ Reliance, in-house), PV platform selection (Oracle Argus, ArisGlobal LifeSphere, Veeva Vault Safety, in-house), Trial Management platform selection (Veeva Vault CTMS, Oracle Clinical, Medidata Clinical Cloud, IQVIA Clinical Trial Management, ClinTrak, in-house), and the integration architecture.

Module 12. Your 10-week build plan

Week-by-week plan with weekly deliverables. Weeks 1-2: pharma GRC landscape + multi-jurisdiction framework. Weeks 3-4: GxP framework + data integrity framework. Weeks 5-6: AI compliance framework + pharmacovigilance framework. Weeks 7-8: supply chain framework + trial transparency framework. Weeks 9-10: anti-corruption framework + engagement framework + technology stack. Deliverable: modern pharma GRC and compliance integration capability.

How this addresses your situation

Specific modules that map to what you said you are dealing with.

Module 1 covers the landscape.

Module 2 produces multi-jurisdiction.

Module 3 covers GxP.

Module 4 covers data integrity.

Module 5 covers AI compliance.

Module 6 covers pharmacovigilance.

Module 7 covers supply chain.

Module 8 covers trial transparency.

Module 9 covers anti-corruption.

Module 10 covers engagement.

Module 11 covers technology stack.

Module 12 covers the 10-week build plan.

What you get with this course

The 12-module course delivered as text plus downloadable templates.
Templates and worked examples for multi-jurisdiction framework, GxP framework, data integrity framework, AI compliance framework, pharmacovigilance framework, supply chain framework, trial transparency framework, anti-corruption framework, engagement framework, technology stack framework.
A hand-built implementation playbook generated for your specific operation.
Three worked examples of modern pharma GRC and compliance integration capabilities at peer firms.
Scripted talking points for the CEO and board-audit-committee engagement.

What you will have in hand by Day 1, Week 1, Month 1

Day 1: Multi-jurisdiction framework scaffold drafted.

Week 4: GxP + data integrity designed.

Week 8: AI compliance + pharmacovigilance + supply chain + trial transparency operational.

Week 10: Capability in operation.

Before and after

Before

Your GRC practice handles classic single-jurisdiction compliance-only patterns. Multi-jurisdiction regulatory complexity strains the operation. AI compliance and data integrity are reactive. Pharmacovigilance multi-jurisdiction signal detection is patchy. Senior global compliance work goes to peers shipping the modern capability.

After

A modern pharma GRC and compliance integration capability is in operation. Multi-jurisdiction framework, GxP framework, data integrity framework, AI compliance framework, pharmacovigilance framework, supply chain framework, trial transparency framework, anti-corruption framework, engagement framework, technology stack framework are all designed.

What happens if you do not address this

Leaders without the modern capability miss senior global compliance work. EU Annex 22 effective possibly 2027; DSCSA fully effective 2025; EU AI Act high-risk obligations August 2026; FDA ALCOA+ expectations tighten.

Who it is for

For pharma GRC and compliance leaders, Chief Compliance Officers, Chief Quality Officers, Chief Regulatory Affairs Officers, senior pharmacovigilance leaders, and senior compliance leaders at global pharma firms.

Who this is NOT for. Pure clinical-research roles without compliance scope. Practitioners at firms with no pharma business. Pure non-compliance roles.

How it arrives

Text-based course via LMS, plus downloadable templates and worked examples and the hand-built implementation playbook.

Time investment. Roughly 18 hours of reading and 100 to 200 hours of compliance-leader effort across the 10-week build.

Why $199 is the right number

External pharma GRC consultants (Big4 life-sciences practices like the firm Life Sciences, the firm Life Sciences, the firm Life Sciences, the firm Life Sciences, specialist firms like McKinsey Pharma, BCG Pharma, Bain Pharma, the firm Life Sciences, the firm Engineering Life Sciences, the firm Life Sciences, IQVIA Consulting, ICON Consulting, Parexel Consulting, Veeva Professional Services) charge $500K-$3M for GRC modernisation programmes. $199 buys the focused playbook plus the implementation document for your specific operation.

FAQ

Will this replace hiring a pharma GRC consultant?

Partially. It teaches the modern capability. You may still want specialist input for complex multi-jurisdiction PV signal detection.

What if my operation is primarily Japan + Korea + China (not US/EU)?

Modules 2 and 6 cover Asia-anchored patterns.

Does this cover oncology-specific compliance considerations specifically?

Modules 3 and 8 cover oncology-specific patterns.

What about rare disease drug compliance?

Modules 2 and 8 cover rare-disease patterns.

What is in the implementation playbook for me specifically?

Multi-jurisdiction framework tailored to your specific operating geography; AI compliance framework matched to your specific AI use cases; a 10-week build plan.

30-day money-back guarantee. If after a week of working through the materials this is not what you needed, reply to the receipt email and a full refund is processed. No questions, no forms.

Within 24 hours your account in the learning environment is provisioned and the tailored implementation playbook is delivered alongside it.