2020 Semi-Annual IVD Clinical and Regulatory Affairs Conferences

October, 2020 | Arlington, VA 
December, 2020 | San Diego, CA 

2020 Semi-Annual IVD Clinical and Regulatory Affairs Conferences
October, 2020 | Arlington, VA
December, 2020 | San Diego, CA

Request Invite

WE GUARANTEE 100% PRIVACY, YOUR INFORMATION WILL NOT BE SHARED

“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:

With an impending compliance date for the EU IVDR as well as updates to FDA’s oversight of diagnostic test, regulatory and clinical affairs executives are tasked with monitoring a multitude of changing requirements in order to remain compliant. With new technology being introduced to IVDs such as machine learning algorithms and wearable technology, companies are staying at the forefront of innovation and forging new pathways to gather clinical evidence to support regulatory approval. In addition, the industry continues to explore less common types of tests such as companion diagnostics, personalized testing, and IVDs with new biomarker developments.

Core Topics to be Addressed:

  • Notified body clarification on the EU In Vitro Diagnostic Regulation
  • FDA requirements & regulations for IVDs, including kits and LDTs
  • Designing clinical trials to deliver robust results for submissions
  • Pharmaceutical partnerships for development of companion diagnostics
  • International requirements for clinical & regulatory compliance for tests

Program Highlights:

  • Breakout group discussions on top challenges & approaches
  • Diverse regulatory & legal perspectives on primary concerns
  • Networking with leading industry executives & organizations

Core Topics to be Addressed:

  • Notified body clarification on the EU In Vitro Diagnostic Regulation
  • FDA requirements & regulations for IVDs, including kits and LDTs
  • Designing clinical trials to deliver robust results for submissions
  • Pharmaceutical partnerships for development of companion diagnostics
  • International requirements for clinical & regulatory compliance for tests

Request Invite

 

WE GUARANTEE 100% PRIVACY, YOUR INFORMATION WILL NOT BE SHARED

Audience

75 Attendees

All attendees come directly from diagnostic companies

Distinguished Presenters

Speaker recruitment in progress

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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