Primarily focused on the In Vitro Diagnostic Regulation, this course will present the latest information and draw out the differences from the In Vitro Diagnostic Directive.

The course will cover:

• Classification & Conformity Assessment
• Quality Management
• Technical Documentation
• Performance Studies and Analytical Data
• Risk Management
• Post-Market Surveillance
• Other Relevant Legislation
• New Regulations
• Labels and IFUs
• Other Regulated Markets 
• Companion Diagnostics and other Emerging Technologies

Speakers Include:

• Aaron Cousins Vice President Quality & Regulatory Affairs Beckman Coulter (Module Leader)
• Stuart Angell Regulatory Affairs Manager Novartis
• Stephen Lee Senior Regulatory Policy Manager IVD MHRA
• Gillian Morgan Director Sestria
• Kim French Regulatory Affairs Team Leader R&D Swiss Precision Diagnostics 
• Alison Gillies Regulatory Affairs Consultant RA Specialists 
• Nancy Consterdine Senior Regulatory Affairs Manager Novartis
• Ben Jacoby Director Cambridge RA   
• Dirk Stynen President - Principal Consultant Qarad 
• Paul Kenny Head of Global Regulatory Affairs The Binding Site
• Daryl Colombage Senior Medical Device Specialist MHRA
• Simon Richards VP Regulatory Affairs EME Abbott 

Who is it for?

What will I learn?

Download the full programme

Learning outcomes:

• Demonstrate critical understanding of the regulatory environment in the EU and the legislative framework
• Demonstrate critical understanding of the regulatory environment and legislative framework in other territories and critically evaluate how these compare to the EU
• Critically evaluate the challenges involved in conducting clinical evidence studies using IVD products, giving consideration to the differences between these products and other medical devices in the design and production of clinical data
• Demonstrate critical understanding of the quality system requirements associated with the manufacture and supply of IVDs
• Demonstrate critical understanding of the roles of the different stakeholders involved in the manufacture, supply and regulation of IVDs.

Skills and attributes:

• Be able to recommend development strategies for IVD products that will meet global requirements
• Explain the regulatory requirements for vigilance and post-market surveillance for IVDs and be able to guide make recommendations about the implementation of a surveillance strategy
• explain the regulatory requirements for the development of an IVD Medical Device and be able to guide the preparation of the IVD technical documentation needed for CE Marking
• Critically appraise and evaluate communications from regulatory bodies and research publications regarding IVDs.

CPD Hours: 21

How do I apply? 

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