This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

IVD Regulations
August 11, 2022
Digital Conference8:00AM EST // 1:00PM BST // 2:00PM CEST
Menu
keyboard_arrow_right

IVD Regulations - ET (Eastern Time, GMT-05:00)

keyboard_arrow_leftSearch & Filter
search
IVD Regulations - ET (Eastern Time, GMT-05:00)
search
8:00am - 8:15am
Welcome Remarks
8:15am - 8:45am
Regulation Changes and Navigating Them
  • Transition period, significant changes
  • Challenges to be expected
  • Requirement differences between MDR, IVD and DDC regulations
  • Availability of information
  • Higher risk IVD regulations
8:45am - 9:15am
Experience of Auditing under IVDR
  • What to expect and challenges
  • Top 3 questions
  • Intended purpose
  • Annex 9 audits
9:15am - 9:45am
Manufacturers Staying up to Date and Compliant
  • Experiences of working with IVDR
  • Date of applications
  • Performance Evaluations and satisfying Notified Bodies
9:45am - 10:15am
Coffee Break
10:15am - 10:45am
Understanding Companion Diagnostics Regulations and Requirements
  • Clinical trials and interpreting results
  • Defining them under IVDR
  • Ensuring approval under IVDR
  • Francesca Cipolli - Associate Director, Precision Medicine and Companion Diagnostics Global Regulatory Sciences, Bristol Myers Squibb
10:45am - 11:15am
Importance of Risk Management and What to Know
  • Establishing a risk management assessment
  • What challenges to expect
  • Risk classifications
  • Shaloo Sood - Product Development Engineer, Institut Straumann AG
11:15am - 11:45am
Expert Panels
  • Performance Evaluation Consultation Procedure
  • Clinical performance of IVDs
  • High Risk IVDs and Class D
11:45am - 12:15pm
Networking Break
12:15pm - 12:45pm
Post Market Surveillance
  • Class C and D help
  • Market Surveillance and Vigilance
  • Safety and performance data
  • Collecting data – how is this being done?
  • Technical documentation
  • Ashleigh Batchen - Regulatory Affairs Manager, British In Vitro Diagnostic Association (BIVDA)
12:45pm - 1:15pm
Lab Market Research and Challenges
  • Safety and performance data
  • Research and challenges
  • Diagnostic tests
  • Analytical performance
1:15pm - 1:45pm
Working with Notified Bodies
  • Capacity
  • Notified bodies expectations
  • What challenges to expect
  • Hybrid Audits
  • How Notified Bodies prioritize work
Filter
Formats
Choose Day