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Referral
ComplianceOnline
2600 E. Bayshore Road
Palo Alto, CA 94303
(888) 717-2436

Event Description

The training program will cover the roles of each legal perspective and how it might work towards regulating laboratory-developed tests (LDTs). The FDA has proposed to actively regulate LDTs. FDA’s regulations overlap with the Clinical Laboratory Improvement Act that falls under the Centers for Medicare and Medicaid Services (CMS).

Why Should You Attend:
The webinar will map out the legal players in the legal skirmish for regulating LDTs. For decades the FDA used enforcement discretion for LDTs, which meant the FDA held its regulatory controls in abeyance. In light of the FDA’s recent draft guidance on regulating LDTs, the webinar will address how FDA plans to actively regulate in-vitro diagnostic laboratories that produce LDTs.

Who Will Benefit:
Laboratory service providers for LDTs
Pathologists and medical practice groups
Third-party insurers/ reimbursement
Patient advocacy groups
In-vitro diagnostic manufacturers

Instructor Profile:
Casper Uldriks, through his firm Encore Insight LLC, brings over 32 years of experience with the FDA. He specialized in FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an associate center director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value.

Note:
Use coupon code 232082 and get 10% off on registration.

For Registration:
http://www.complianceonline.com/new-regulatory-brew-for-laboratory-developed-tests-webinar-training-704027-prdw

There may be many networking opportunities at the The New Regulatory Brew for Laboratory Developed Tests. Find out more in the event details below.

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Event Details

Website: http://www.complianceonline.com/new-regulatory-brew-for-laboratory-dev...
Conference/Event Dates: 07/21/2015 - 07/21/2015
Conference/Event Hours: 10:00 am to 11:00 am
Classification: B2B
Primary Industry: Pharmaceutical
Other Industries: Clinical Pharmacology, Pharmaceutical, Professional Healthcare
Cost to Attend: One Registration : 229
Audience: Laboratory service providers for LDTs
Pathologists and medical practice groups
Third-party insurers/ reimbursement
Patient advocacy groups
In-vitro diagnostic manufacturers
Show Owner:ComplianceOnline

Booth Details

Booth Size Booth Cost   Available Amenities
No exhibiting.   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: n/a
Other Booth Sizes Available: n/a

Advance Networking

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Mark Travers

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The New Regulatory Brew for Laboratory Developed Tests

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