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Date(s) - 12/05/2018 - 12/06/2018
All Day

Embassy Suites Old Town


NAMSA invites you to join us at the Q1 Productions 11th Annual IVD Regulatory Affairs Conference in Alexandria, VA on December 5-6. This event will bring together industry leaders, as well as health authority representatives from the U.S. and beyond to discuss recent critical guidance related to In Vitro Diagnostics (IVD) development. In addition, the conference will offer a unique networking platform for delegates to connect with a multitude of key experts in the field.

NAMSA Education Session: Navigating Planning Considerations for Early-Stage Product Development
December 5 (11:30 a.m.) 
Sonia Lecce; Sr. Medical Research Manager (NAMSA)

Description: The ability to navigate the early stages of IVD development if often a key differentiator as to whether an organization will be a top performing company. A well-planned approach can yield significant competitive advantages by shortening time-to-market without adding excessive costs. Planning appropriately will not cover every possible scenario, but can help frame and gauge time to market and lessen costs.

Topics to be discussed:

  • Intellectual Property (IP) protection
  • Market opportunity, competitive environment and other opportunity factors
  • Regulatory requirements for market approval
  • Needs to demonstrate product safety and efficacy
  • Requirements for manufacturing with appropriate controls
  • What investors are looking for
  • How the product will be reimbursed (paid for) and by whom

Complimentary Consultations 
Throughout this event, NAMSA will have IVD development experts available for 30-minute complimentary consultations in the exhibitor area. We welcome the opportunity to discuss with you the most cost-effective pathway to market based on your unique product development requirements. We’ll also walk you through our latest case study with French biosurgical firm, Biom’Up, and help you understand how NAMSA provided the organization savings of $17M and 23 months in PMA development timelines (read case study here). Please email us at communications@namsa.com to reserve your consultation time.

Learn More about NAMSA’s IVD Services & Resources