The Israel Chapter of PDA Invites you to

  A ONE-DAY SEMINAR

on

Organised by

Karin Baer (Omrix) and Eitan Gross (Kamada)

To be held on Monday, July 2, 08:30-17:00h
at Lev Hakongressim, Weizmann Science Park, Ness Ziona

A combination product includes : (1) A product comprised of two or more regulated components, i.e ., drug/device, biological product / device, drug/biological product, or drug/device/biological product, that are physically, chemically, or otherwise combined or mixed and produced as a single entity; (2) two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products; (3) a drug, device, or biological product packaged separately that, according to its investigational plan or proposed labeling, is intended for a defined use. "

Program:

Time Topic Lecturer 09:15 – 09:30 Opening Notes Raphy Bar, PDA Israel Chapter President 09:30 - 10:15 Device Regulations & Requirements in Israel Nadav Sheffer AMAR, Ministry of Health 10:15– 10:45 Combination products - The new trend Karin Baer Omrix 10:45– 11:30 Coffee Break 11:30– 12:15 Patches-QA/RA requirements for a combination product-case study Hana Gadasi TransPharma 12:15 – 13:00 Regulatory Affairs Overview - Working with a Notified Body Adi Ickovicz Medicsense 13:00– 14:00 Lunch 14:00– 14:45 Preparing a Medical Device Company for FDA Inspection Boris Aradovsky  VisionCare 14:45– 15:15 Insulin Pumps-combination products QA/RA aspects Doron Bushi Medingo 15:15 – 15:45 Teabreak 15:45 – 16:30 PillCam™ Capsule Endoscopy – QA and regulatory aspects Hezi Erez Given Imaging 16:30– 17:00 Panel Discussion Seminar Speakers

Location:

Lev Hakongressim, Weizmann Science Park, Ness Ziona
for map please click here
Telephone: +972-8-93-13-070

Seminar fees:
Members : 690 shekel
Non-members: 885 shekel

Registration is mandatory, please register here.