Why Pharma Teams Choose GxPVigilance
Generic AI training ignores regulatory reality. Teams leave with ideas they can’t implement — and inspectors ask questions the trainer never covered.
Practical • Audit-ready • Regulator-aligned
The Problem
Most AI training isn’t built for regulated pharma.
- Regulatory constraints are missing: TGA/FDA expectations, validation, and audit trails.
- Ideas don’t translate to action: frameworks without implementation detail.
- Inspection risk increases: teams can’t defend the “why” behind decisions.
Our Difference
AI you can deploy — and defend.
- Regulator-acceptable implementation: traceability, documentation, justification.
- Independence: capability transfer, not consulting dependency.
- Pharma-only scenarios: PV triage, literature monitoring, protocol review with oversight.
- Fits your QMS: aligned to ISO 9001 + GAMP 5.
What You Actually Get
Practical deliverables — not fluff.
Not:
Certificates, vendor partnerships, or generic frameworks
Certificates, vendor partnerships, or generic frameworks
Yes:
Workflows, templates, and audit-ready evidence your team can use immediately
Workflows, templates, and audit-ready evidence your team can use immediately
Deployable workflows
Literature search agents, case triage, protocol analysis — built during training.
Validation templates
CSV/GAMP 5/ALCOA+ aligned documentation that supports inspection readiness.
Risk playbooks
Bias checks, drift monitoring, and hallucination controls are designed for pharma use.
- Decision frameworks: enterprise vs open models, cloud vs on-prem.
- Audit-ready documentation: AI assists without replacing human judgment.
- Regulatory strategy: ethics submissions, IND/CTA workflows, AI-related device paths.
Next step: Contact us to discuss your AI challenges, inspection questions, and a realistic timeline.
Artificial Intelligence in Pharmacovigilance
4-Hour Hands-On Online Workshop | Launching 10 March 2025
A practical workshop structured around the CIOMS Working Group XIV Seven Guiding Principles for responsible AI deployment in pharmacovigilance. Learn to implement AI safely in safety operations while maintaining inspection readiness and patient safety. No coding or technical background required.
Course Outline
- Session 1: AI Fundamentals & The CIOMS Framework — Key AI methodologies (ML, NLP, LLMs), the PV landscape, and seven guiding principles overview
- Session 2: Risk-Based Approach, Human Oversight & Validation — Risk classification, HITL/HOTL models, and validation approaches for AI systems
- Session 3: Privacy, Security, Bias & Ethical Considerations — Data protection, bias mitigation, fairness, and transparency requirements
- Session 4: Governance, Accountability & Implementation — Organisational readiness, audit preparation, workforce enablement, and change management
What You’ll Learn
- Understand key AI methodologies: machine learning, natural language processing, classifications, and large language models (LLMs)
- Evaluate leading AI tools for PV use — ChatGPT, Gemini, Claude, Copilot — including their benefits and limitations
- Recognise and manage risks related to data privacy, security, bias, and ethical concerns
- Apply the CIOMS seven guiding principles to AI implementation decisions
- Design human oversight frameworks and validation criteria for AI-assisted PV processes
- Address organisational implications: governance, audit readiness, workforce enablement, and change management
Who Should Attend
- QPPVs, A-PVCPs, and local safety officers
- Safety physicians and medical reviewers
- Case processors and signal analysts
- PV operations and quality managers
Artificial Intelligence in Clinical Trials
4-Hour Hands-On Online Workshop | Launching 11 March 2025
A practical workshop for clinical research professionals ready to use AI tools safely and effectively. Learn to apply AI across the trial lifecycle — from protocol development to close-out — while maintaining GCP compliance and data integrity. No coding or technical background required.
Course Outline
- Session 1: AI & Machine Learning — Key concepts, emerging applications, and the AI landscape in clinical research
- Session 2: Enhancing Trial Design & Data Analysis — The role of AI in improving efficiency, plus automation opportunities across the trial lifecycle
- Session 3: Regulatory & Ethical Considerations — Compliance requirements, risk management, and CSV implications for AI-enabled systems
- Session 4: Implementing AI in Clinical Research — Prompt engineering techniques, workflow integration, and practical tool adoption
What You’ll Learn
- Write effective prompts for research documentation, analysis, and reporting tasks
- Identify automation opportunities that reduce manual effort without compromising quality
- Understand how AI impacts computerised system validation (CSV) and GAMP 5 considerations
- Select tools based on privacy requirements, data sensitivity, and validation needs
- Document AI assistance to meet GCP, ICH E6(R3), and ethics committee expectations
- Build team confidence through practical, low-risk starting points
Who Should Attend
- Clinical trial coordinators and research staff
- Clinical operations and project managers
- Research administrators and quality personnel
- HREC/ethics committee officers
Pharma Professionals: The Perplexity Guru
3-Hour Intensive Online Workshop | Master AI-Powered Research for Pharmaceutical Intelligence (24 February 2026)
Transform from passive information consumer to strategic research operator. Master Perplexity AI—the answer engine fundamentally different from ChatGPT—to conduct regulatory intelligence, competitive analysis, and evidence synthesis with unprecedented speed while maintaining the citation rigor demanded by pharmaceutical professionals.
Course Outline
- Session 1: Perplexity Fundamentals — The answer engine mindset, dual-engine architecture, Focus modes, source evaluation, and why real-time citations matter for pharma
- Session 2: Advanced Search Techniques — Prompt engineering for pharmaceutical intelligence, multi-phase Deep Research, Perplexity Spaces for specialized domains
- Session 3: Pharmaceutical Use Cases — Regulatory intelligence, competitive analysis, literature reviews, document analysis (PDF upload), vendor assessment
- Session 4: Advanced Features & Productivity — Comet Browser automation, citation management, API integration, building your research workflow system
What You’ll Master
- Design high-quality prompts using Context + Specificity + Constraints + Output format for precise pharma answers
- Complete competitive trial landscape analysis in 30 minutes (vs. 8+ hours traditional research)
- Conduct rapid peer-reviewed literature reviews using Academic Focus and Deep Research capabilities
- Use Comet Browser to extract data from ClinicalTrials.gov, regulatory databases, and technical websites
- Analyze 100+ page documents (protocols, guidance, vendor reports) in minutes via PDF upload
- Evaluate source credibility using Tier 1/2/3 hierarchy (regulatory agencies vs. industry vs. opinion)
- Build audit-trail research workflows meeting regulatory documentation standards
- Achieve 70%+ time savings on research tasks while improving citation quality
Who Should Attend
- Regulatory affairs professionals and compliance specialists
- Pharmacovigilance and drug safety officers
- Clinical research associates and medical monitors
- Quality assurance, validation, and GxP auditors
- Medical affairs and evidence generation teams
- Pharmaceutical consultants and advisors
Technical Writing with AI and Microsoft Copilot
4-Hour Hands-On Online Workshop | Launching 17 March 2025
A practical workshop for professionals who write SOPs, protocols, reports, and regulatory documents. Learn to use Microsoft Copilot effectively while maintaining the accuracy, traceability, and quality standards required in regulated environments. No prior Copilot experience required.
Course Outline
- Session 1: Understanding Copilot & Technical Writing Foundations — How Copilot works within M365, data handling, good technical writing principles, and structuring source documents
- Session 2: Writing & Researching with Copilot — Drafting from templates vs blank documents, using reference materials, iterative section building, and research techniques
- Session 3: Styling, Templating & Quality Control — Consistent formatting, building reusable templates, verification processes, and accuracy checks for GxP standards
- Session 4: Advanced Techniques & Audit-Ready Documentation — Long document strategies, M365 integration, maintaining audit trails, and documenting AI assistance
What You’ll Learn
- Understand how Microsoft Copilot processes documents and where your data goes
- Structure source documents to get better, more accurate AI outputs
- Apply good technical writing practices: clarity, precision, consistency, and appropriate tone
- Build reusable templates and style guides that work with Copilot assistance
- Verify AI-generated content for accuracy, completeness, and traceability
- Document AI assistance to meet quality system and audit requirements
Who Should Attend
- Quality and regulatory document authors
- SOP writers and technical writers
- Regulatory affairs professionals
- Anyone preparing controlled documents in GxP environments