Domains You Will Master

Topics: Case processing, literature review, signal basics

Hands-on: Full case lifecycle

Audience: Professionals / Students / Engineers

Outcome: Advanced PV • Entry to mid-level roles

Mode: Virtual / Face-to-Face / Hybrid

Topics: Protocol design, monitoring, safety reporting

Hands-on: Site monitoring simulation

Audience: Professionals / Students / Engineers

Outcome: Clinical depth • DRA / QC / CRA / CRC roles

Mode: Virtual / Face-to-Face / Hybrid

Topics: PMS, PMCF, FSCA, risk management

Hands-on: Device risk analysis

Audience: Professionals / Students / Engineers

Outcome: Device expertise • Entry to specialist roles

Mode: Virtual / Face-to-Face / Hybrid

Topics: Submission process, audits, compliance

Hands-on: Mock audits

Audience: Professionals / Students / Engineers

Outcome: Global exposure • QC / Engineering / Regulatory roles

Mode: Virtual / Face-to-Face / Hybrid

Topics: Safety DB, EDC, AI in Healthcare

Hands-on: Tool demos

Audience: Professionals / Students / Engineers

Outcome: Tech integration • Future readiness

Mode: Virtual / Face-to-Face / Hybrid

Topics: End-to-end processing, QC, mock audits

Hands-on: Real simulations

Audience: Professionals / Students / Engineers

Outcome: Hands-on expertise • Industry ready

Mode: Virtual / Face-to-Face / Hybrid

Topics: Quantitative analysis, benefit–risk, global strategy

Hands-on: Signal exercises

Audience: Professionals

Outcome: Expert PV • Leadership roles

Mode: Hybrid

Topics: RBM, data management, inspection readiness

Hands-on: Audit simulations

Audience: Students

Outcome: Senior CRA roles

Mode: Hybrid

Topics: EU MDR, ISO 14971, SaMD

Hands-on: Device lifecycle project

Audience: Engineers

Outcome: Specialization • Consulting roles

Mode: Hybrid

Topics: Drug–device integration, regulatory complexity

Hands-on: Case scenarios

Audience: All

Outcome: High-demand niche roles

Mode: Hybrid

Topics: Governance, stakeholder management, project management

Hands-on: Capstone project

Audience: Professionals

Outcome: Leadership readiness • Manager roles

Mode: Hybrid

Topics: End-to-end safety project

Hands-on: Final presentation

Audience: All

Outcome: Real-world validation • Consulting readiness

Mode: Hybrid

Topics: History (Thalidomide), PV lifecycle, AE/SAE/SUSAR, FDA, EMA, CDSCO

Hands-on: Mock case intake

Audience: Students, Pharmacy Undergrads

Outcome: Entry-level Drug Safety roles

Topics: MedDRA, WHODrug, Narrative writing

Hands-on: Coding scenarios

Audience: Freshers, PV Associates

Outcome: ICSR processing expertise

Topics: PBRER, PSUR, Signal detection

Hands-on: Report drafting

Audience: PV Scientists

Outcome: Safety Scientist roles

Topics: ISO 14971, RMP, REMS

Hands-on: Risk strategy

Audience: Senior PV Scientists

Outcome: Risk Management Specialist

Topics: EU MDR, FDA MDR, PMS

Hands-on: Device mapping

Audience: Industry Professionals

Outcome: Device Safety SME

Topics: PSMF, CAPA, QPPV

Hands-on: Audit simulation

Audience: Managers, Directors

Outcome: Leadership roles

Topics: Device classification, Intended use, Metal-on-metal history

Hands-on: User error vs malfunction cases

Audience: Biomedical/Pharma students

Outcome: Entry-level safety roles

Topics: EU MDR, FDA MDR, CDSCO, IMDRF basics

Hands-on: Mock reporting (serious health threat)

Audience: PV & Regulatory professionals

Outcome: Regulatory compliance expertise

Topics: IMDRF coding, RCA, CER

Hands-on: Failure → clinical mapping

Audience: Engineers, Safety Scientists

Outcome: Technical analysis expertise

Topics: PMS, FSCA, Recalls, Trend reporting

Hands-on: Field Safety Notice drafting

Audience: PMS Leads, QA Managers

Outcome: PMS leadership roles

Topics: ISO 14971, RMF, Benefit-risk

Hands-on: Risk matrix creation

Audience: Senior leadership

Outcome: Risk Management Director

Topics: PMOA, Drug-device integration, 21 CFR 4

Hands-on: Case study (stent/syringe)

Audience: Senior professionals

Outcome: MedTech SME roles

Topics: FDA, EMA, PMDA, PLM, IND/NDA/BLA/MAA

Hands-on: Drug journey mapping (multi-region)

Audience: Students, Entry-level RA

Outcome: Regulatory Associate roles

Topics: CTD Modules 1–5, eCTD v3.2.2 vs v4.0

Hands-on: Dossier building (Module 3)

Audience: RA Associates

Outcome: eCTD Publishing Specialist

Topics: Variations, Labeling, Artwork, Project tracking

Hands-on: Global submission tracker

Audience: RA Professionals

Outcome: Regulatory Operations Lead

Topics: SUPAC, Variations, Renewals, Tech transfer

Hands-on: Filing category assessment

Audience: Senior RA / Manufacturing

Outcome: CMC Regulatory Manager

Topics: UDI, GSPR, MDR/IVDR, Tech files

Hands-on: GSPR gap analysis

Audience: MedTech & RA specialists

Outcome: Device Regulatory SME

Topics: FDA meetings, PSP/PIP, Orphan drugs

Hands-on: FDA Type B meeting simulation

Audience: Managers, Directors

Outcome: Head of Regulatory

Topics: Structured vs unstructured data, GIGO, stats vs ML

Hands-on: Data cleaning using Python/R

Audience: Students, Researchers

Outcome: Data-savvy CRA roles

Topics: ML, Deep Learning, QSAR

Hands-on: Virtual screening model

Audience: Bioinformatics, R&D

Outcome: Computational Biologist

Topics: NLP, Automated case intake, Signal detection

Hands-on: Sentiment analysis tool

Audience: PV professionals

Outcome: PV Automation Lead

Topics: SaMD, GAMP 5, AI compliance

Hands-on: Bias audit

Audience: RA & QA

Outcome: AI Compliance Manager

Topics: Digital biomarkers, recruitment optimization

Hands-on: Predictive enrollment model

Audience: Clinical Ops

Outcome: Clinical Data Scientist

Topics: AI strategy, ROI, digital transformation

Hands-on: AI roadmap (3-year plan)

Audience: Senior leaders

Outcome: Digital Transformation Director