In Vitro Diagnostic Regulatory Affairs Course

Name: In Vitro Diagnostic Regulatory Affairs Training Course
Availability: InStock

Advanced IVD regulatory strategy, classification, performance evidence, quality, market access, and post-market governance

In Vitro Diagnostic Regulatory Affairs Course

At a glance

Duration: 1 Week
Format: Classroom
Cities: Madrid, Cairo, Rome, Trabzon, Sharm El-Sheikh, Chicago and more
Next session: 26 – 30 October 2026, Madrid
Average fee: 5,750 €

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In Vitro Diagnostic Regulatory Affairs Training Course

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Overview

In Vitro Diagnostic Regulatory Affairs Training Course is a one-week advanced programme for professionals who plan, assemble, review, or maintain regulatory evidence for in vitro diagnostic devices. Participants connect intended purpose, qualification, classification, conformity assessment, quality management, risk management, performance evaluation, technical documentation, economic-operator responsibilities, market access, post-market surveillance, vigilance, and lifecycle change control. The course uses the European IVD regulatory framework as a structured case environment while requiring every participant to verify current jurisdiction-specific obligations with authorised regulatory and legal specialists.

Each participant develops an IVD Regulatory Pathway Dossier for a selected diagnostic product. The dossier brings together a regulatory strategy, classification rationale, evidence map, quality and risk interfaces, performance-evaluation plan, submission readiness review, surveillance design, and governance calendar. Agile Leaders Training Center presents regulatory affairs as a traceable lifecycle system rather than a one-time submission exercise.

Who Should Attend

Regulatory-affairs professionals responsible for diagnostic product strategy, submissions, registrations, and change assessment
Quality-assurance professionals maintaining an IVD quality management system and regulatory records
Clinical, scientific, and performance-evaluation teams responsible for analytical and clinical evidence
Risk-management and product-safety specialists linking hazards, controls, performance, and surveillance
Research, development, engineering, and product-management teams preparing IVD products for market
Manufacturing, supply-chain, and authorised-representative teams supporting economic-operator obligations
Internal auditors and compliance professionals reviewing regulatory readiness and lifecycle controls

This advanced course assumes familiarity with medical-device or diagnostic product development. It does not provide legal advice, certification, notified-body approval, or a jurisdiction-specific market authorisation.

Departments and Industries

The course supports in vitro diagnostic regulatory affairs across:

Regulatory affairs, quality assurance, clinical affairs, medical affairs, product safety, and compliance
Diagnostic manufacturers, laboratories, biotechnology companies, software-enabled diagnostic developers, and contract organisations
Importers, distributors, authorised representatives, research institutions, and healthcare technology organisations
Product development, manufacturing, supply chain, post-market surveillance, and executive governance functions

Learning Objectives

Map the IVD ecosystem, relevant actors, and regulatory responsibilities across the product lifecycle
Define intended purpose and document qualification and classification decisions
Select and justify a conformity-assessment and market-access pathway
Connect quality-system processes, risk management, and regulatory evidence
Structure analytical, clinical, and scientific performance-evaluation evidence
Plan technical documentation and conduct an evidence-readiness review
Design post-market surveillance, vigilance, trend reporting, and corrective-action interfaces
Govern regulatory changes, renewals, registrations, and continuing obligations

Practical Work Product

Participants build an IVD Regulatory Pathway Dossier containing:

Product and intended-purpose profile
Qualification and classification decision record
Actor and responsibility map
Conformity route and evidence requirements matrix
Quality and risk-management interface map
Performance-evaluation evidence plan
Technical-documentation readiness tracker
Post-market surveillance and vigilance framework
Regulatory change and governance calendar

Day 1: IVD Regulatory Ecosystem and Product Scope

Diagnostic product lifecycle and the roles of manufacturers, authorities, notified bodies, laboratories, representatives, importers, and distributors
Product concept, intended purpose, target population, specimen, user, setting, and claimed benefit
IVD qualification boundaries and interfaces with medical devices, laboratory-developed activities, research-use products, and software
Regulatory intelligence sources, controlled assumptions, and evidence traceability
Responsibility assignment through a regulatory actor map and decision log

Workshop: create the product profile, stakeholder map, and regulatory-question register for the IVD Regulatory Pathway Dossier.

Day 2: Classification and Market-Access Pathway

Risk-based classification logic and the evidence needed to support a classification rationale
Classification rules, special characteristics, companion diagnostics, self-testing, near-patient testing, and software considerations
Conformity-assessment routes and the consequences of product class for external assessment
Economic-operator readiness, registration, identification, labelling, and language considerations
Market-access sequencing, dependency mapping, and regulatory milestone planning

Workshop: produce a documented classification rationale, conformity route, and milestone map with explicit assumptions and escalation points.

Day 3: Quality, Risk, and Technical Documentation

IVD quality management system interfaces with design, suppliers, production, verification, release, complaints, and corrective action
Risk-management planning, hazard identification, risk controls, benefit-risk reasoning, and residual-risk communication
Traceability between intended purpose, requirements, risks, verification, validation, labelling, and claims
Technical-documentation architecture, document ownership, version control, and evidence-status tracking
Submission-readiness reviews, evidence gaps, remediation priorities, and governance checkpoints

Workshop: build a quality-risk-regulatory traceability matrix and a technical-documentation readiness tracker.

Day 4: Performance Evaluation and Evidence Governance

Scientific validity, analytical performance, and clinical performance as connected evidence streams
Performance-evaluation planning, acceptance criteria, data provenance, protocol controls, and report structure
Study governance, specimen considerations, bias, limitations, deviations, and evidence quality
Claim-evidence alignment and disciplined review of labels, instructions, promotional statements, and intended users
Evidence maintenance, literature monitoring, performance follow-up, and lifecycle updates

Workshop: create a performance-evaluation evidence map that links claims, endpoints, data sources, gaps, owners, and approval decisions.

Day 5: Post-Market Control and Regulatory Governance

Post-market surveillance planning, complaint inputs, performance signals, trend review, and periodic reporting
Vigilance assessment, reportability decisions, timelines, field actions, and authority communications
Corrective and preventive action interfaces with risk files, performance evidence, labelling, and product changes
Change assessment for design, supplier, manufacturing, software, intended purpose, claims, and market expansion
Regulatory governance dashboard, renewal calendar, management review, escalation, and audit readiness

Capstone: present and challenge the completed IVD Regulatory Pathway Dossier through a simulated cross-functional regulatory review board.

Training Methods

Facilitated regulatory pathway mapping and decision exercises
Diagnostic product case studies with incomplete or conflicting evidence
Classification, traceability, and performance-evaluation workshops
Cross-functional review-board simulation and peer challenge
Templates for evidence mapping, readiness tracking, surveillance, and change governance

Course Outcomes

Participants leave able to organise a defensible regulatory pathway, expose evidence gaps early, assign accountable owners, and maintain product compliance throughout the IVD lifecycle. They also leave with a practical dossier structure that can be adapted to their organisation only after review against current laws, guidance, quality procedures, and market-specific requirements.

Frequently Asked Questions

Does the course cover the European IVD regulatory framework?

Yes. It uses the European framework and related guidance as a structured learning environment, while distinguishing regulatory principles from advice for a specific product or market.

Is this an introductory IVD course?

No. It is designed for experienced professionals who need to integrate regulatory, quality, risk, performance, and post-market work into one governed pathway.

Does completing the course confer certification or market approval?

No. Course completion does not constitute certification, conformity assessment, regulatory authorisation, or legal advice.

What practical document will I produce?

You will build an IVD Regulatory Pathway Dossier containing the core decision records, evidence maps, readiness controls, and lifecycle governance tools developed during the one week.

credits: 5 credit per day

Course Mode: full-time

Provider: Agile Leaders Training Center

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Showing 41-60 of 75 events

Location	Dates	Duration	Mode	Price
London	Week 19, 2027 10 – 14 May 2027	1 Week	Onsite	€5,700
Zanzibar	Week 19, 2027 16 – 20 May 2027	1 Week	Onsite	€5,500
Singapore	Week 20, 2027 17 – 21 May 2027	1 Week	Onsite	€5,700
Madrid	Week 21, 2027 24 – 28 May 2027	1 Week	Onsite	€5,700
Nice	Week 21, 2027 24 – 28 May 2027	1 Week	Onsite	€5,700
Jakarta	Week 22, 2027 31 May – 4 June 2027	1 Week	Onsite	€5,700
Dubai	Week 23, 2027 7 – 11 June 2027	1 Week	Onsite	€4,500
Accra	Week 23, 2027 13 – 17 June 2027	1 Week	Onsite	€4,100
Amman	Week 24, 2027 20 – 24 June 2027	1 Week	Onsite	€4,100
Manama	Week 25, 2027 27 June – 1 July 2027	1 Week	Onsite	€4,700
Phuket	Week 26, 2027 4 – 8 July 2027	1 Week	Onsite	€6,000
Abu Dhabi	Week 27, 2027 5 – 9 July 2027	1 Week	Onsite	€4,700
Doha	Week 27, 2027 11 – 15 July 2027	1 Week	Onsite	€5,500
Marbella	Week 28, 2027 18 – 22 July 2027	1 Week	Onsite	€5,700
Kuala Lumpur	Week 29, 2027 19 – 23 July 2027	1 Week	Onsite	€5,200
London	Week 30, 2027 26 – 30 July 2027	1 Week	Onsite	€5,700
Toronto	Week 31, 2027 8 – 12 August 2027	1 Week	Onsite	€12,000
Cairo	Week 32, 2027 9 – 13 August 2027	1 Week	Onsite	€4,100
Istanbul	Week 33, 2027 16 – 20 August 2027	1 Week	Onsite	€4,500
San Diego	Week 33, 2027 16 – 20 August 2027	1 Week	Onsite	€14,000

Frequently asked questions

What does this course cover?

Overview In Vitro Diagnostic Regulatory Affairs Training Course is a one-week advanced programme for professionals who plan, assemble, review, or maintain regulatory evidence for in vitro diagnostic devices. Participants connect intended purpose, qualification, classification, conformity assessment, quality management, risk management, performance evaluat…

Are training dates available?

Yes. Available dates and destinations are listed in the course dates section on this page.

How can I register?

Choose an available date on this page and complete the registration form, or send a programme enquiry.

Can I download the course brochure?

Yes. Use the brochure download link provided on this page.

In Vitro Diagnostic Regulatory Affairs Course