15th Annual IVD Clinical & Regulatory Affairs Conference

December 13-14, 2021 | Virtual Event

$1,500 for Virtual Registration

Target Audience:
Regulatory Affairs
Clinical Affairs
Medical Writers

Industries Represented:

Optimize submission strategies to secure approval from global regulatory authorities for innovative & existing products

As global regulations change, IVD manufacturers must adapt to a vastly different regulatory environment. The swiftly approaching EU IVDR has created a challenge for regulatory and clinical affairs professionals in the diagnostic space, as companies must find harmony between the multitude of different regulations in the EU, UK, Switzerland, Canada, China, and the US.

The 15th Annual IVD Clinical & Regulatory Affairs Conference will feature industry experts from leading diagnostic organizations and notified bodies to discuss global regulatory changes and compliance strategies.

You will learn how to align technical deliverables, including clinical evaluation reports and terminology within current guidelines. You will also learn strategies to minimize regulatory risk in future market opportunities, novel tests and across product portfolios.

This is a two-day program with multiple breaks to maximize retention and engagement. Q1 Production’s advanced event platform offers the ultimate virtual experience. Thoughtfully designed, customizable, networking features foster a sense of collaboration, discussion, allowing attendees to make direct connections.

Main topics include:

  • Interpreting EU IVDR guidance changes impacting clinical trial operations
  • Creating a secure database for effective diagnostic cybersecurity
  • Strengthening cybersecurity operations for global product lines
  • Valid Act: analysis of updated regulations for IVD manufacturers
  • Interpreting EU IVDR guidance changes impacting clinical trial operations
  • Navigating the regulatory approval process for non-cancer diagnostic tests

Featured speakers:

  • Andreas Stange, PhD, VP, MHS Global IVD, TÜV SÜD
  • Jennifer Paine, Head of WW Regulatory Affairs, JOHNSON & JOHNSON
  • Brad Spring, VP, Regulatory Strategy, Policy & Intelligence, BD
  • Peter Shearstone, VP, Global Quality Assurance and Regulatory Affairs, THERMO FISHER SCIENTIFIC
  • Susan Van Meter, Executive Director, ADVAMED

Chris Cockerell


Chris Cockerell, Senior Event Manager
Q1 Productions
+1 (312) 224-8722