12th Annual IVD Regulatory Affairs Conference

December 2019 | Arlington, VA
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“I thought the conference was excellent!  Having a conference tailored to one discipline made each panel and contact relevant.”

Director, Compliance & Legal Affairs
Orexigen

“Great insight to hear payer perspective in contracting and account management and the changing healthcare landscape.”

Channel Liaison
Biogen

“It was definitely an excellent well-rounded opportunity to meet new people, get new ideas, and get an in-depth education on what’s to come with the FDA collaborations.”

Quality Engineer
Centurion Medical Products

“It was very well organized event and high quality, the fact to have an IVD track was also interesting. Thanks, I will recommend the Q1 event!”

Regulatory Affairs – EMEA Regional Head
BIOMERIEUX

“The organization and support staff were fantastic! I’m looking forward to next year.”

Global Business Project Lead
Genentech

About the Conference:

Diagnostic test sophistication, including the rapid integration of Next Generation Sequencing and machine learning into diagnostic testing are changing the way that healthcare professionals approach diagnosis, as well as the regulations surrounding such advanced methods. From the US FDA’s stance surrounding regulation of Laboratory Developed Tests (LDTs) as well as Next Generation Sequencing, to considerations of the EU IVDR, regulatory affairs executives face a wide range of challenges in ensuring tests meet evidence and regulatory dossier requirements.

Core Topics to be Addressed:

  • Strategic Alignment for Companion Diagnostics
  • Post-Market Surveillance & Quality Concerns
  • Implementation of European IVD Regulation (IVDR)
  • Regulatory Changes for Varied Test Categories
    • Laboratory Developed Tests
    • Next Generation Sequencing
    • Companion Diagnostics
    • CLIA Waivered Tests

Program Highlights:

  • Participation from US FDA Reviewers
  • Multiple European Notified Body Participants
  • Industry Stakeholder Presentations

Audience

75 Attendees

All attendees come directly from laboratories and diagnostic companies

Distinguished Presenters

Speaker recruitment in process

Networking

Networking time is built into the agenda to allow industry peers to connect and exchange ideas

Open Dialogue and Group Share

Each presentation is followed by 10-15 minutes of open dialogue for questions and exchange of best practices

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