Advanced Training on US FDA IVD Regulations & the New EU IVDR
EX-FDA on FDA Regulation
Notified Body
on EU MDR
ISRAC on Medical lab Accreditation
Registration
EX-FDA on FDA Regulation
Notified Body
on EU MDR
ISRAC on Medical lab Accreditation
Registration
About
This one-day seminar is intended to educate manufacturers of in-vitro diagnostics, companion diagnostics and Laboratory Developed Test (LDTs) about the up-to-date regulatory expectations in the US, the EU (new EU IVDR) and Israel. The speakers include Ex-FDA IVD officer, IVD expert from BSI (Notified Body), the General Manager of ISRAC (Israel Laboratory Accreditation Authority) and the Head of IVD Practice at Physio-Logic.
*Certificate of attendance will be provided to seminar participants.
Agenda*
08:30-09:00
Gathering -Light Breakfast
09:00-09:10
Welcome note
G. Ginot
09:10-10:00
Introduction to FDA IVD Regulatory Framework
Dr. E. Cowan
10:00-10:30
FDA IVD Pre-Market Activities: Pre-subs, 510(k) and PMA pathways
Dr. E. Cowan
10:30-10:45
Coffee break
10:45-11:30
Accreditation to ISO 15189 Professional requirements from diagnostic products
Etty Feller
11:30-12:15
The new EU IVDR – Notified BodyPerspective
12:15-13:00
Practical guide on how to approach the transition to the new EU IVDR
Dr. T. Katzav
13:00-14:00
Lunch
14:00-14:30
IVD Analytical & Clinical Performance toFDA Expectations
Dr. E. Cowan
14:30-15:00
CLIA
Dr. E. Cowan
15:00-15:30
LDT & Companion Diagnostics
Dr. E. Cowan
15:30-15:45
Coffee break
15:45-16:30
FDA IVD Labeling Requirements
Dr. E. Cowan
16:30-17:00
Open discussion on FDA and EU IVD Regulations
Speakers
17:00-18:00
1X1 complimentary meeting (RSVP only)
Speakers
Etty Feller
General Manager, ISRAC
M.Sc. degree in Biochemistry and a Business Administration with a major in management. Over the worked in pharmaceutical companies in roles including Quality Control, Development of portfolio, Filing for FDA registration and clinical trial of approximately 300 patients as a VP QA. Mrs. Feller initiated the medical laboratory accreditation dev. reference material and proficiency testing accreditation and GLP in accordance with the OECD principles and GCLP.
Dr. Tamar Katzav
Head of IVD Practice, Physio-Logic
Tamar will act as a focal point and coordinate the activities needed for the realization of the project. Tamar brings forward over 12 years of experience in leading quality assurance, compliance and regulation of medical devices, active substances and drugs. Tamar holds three academic degrees (Biology, Molecular Microbiology and Biotechnology, and Zoology) and has over 15 years of biological research experience.
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Dr. Elliot Cowan
Senior IVD Regulation Expert, IVD Practice, Physio-Logic
Elliot is a former FDA officer (20 yr., including asChief of FDA’s Product Review Branch for IVDs) and a renowned regulatory expert in global IVD regulation. He has also served as an advisor to the World Health Organization for the evaluation of IVDs and is Physio-Logic’s expert on IVD regulation.
IATI
Members, Physio-Logic customers
275 NIS
Early registration
Until March 1st
325 NIS
Early registration
Past March 1st
450 NIS
E-mail:
gila@physio-Logic.co.il
Phone:
03-9416297
This event is intended only for manufacturers. The organizers reserve the right to make changes to the agenda* and deny registration.