Overview of the different Guidance Documents
Karen Ginsbury
PCI Ltd.
MOH Approach and Expectations Rina Heimlich
MOH
The required Mindset-what does DI really mean? Karin Baer
Teva
Case Study IT - computerized systems Moshe Radovitch
Tera-zon

Main topics:

  • Data Integrity - the Ministry of Health's policy
  • Guidance overview
  • Industry case studies and plans for implementations and improvement
בהשתתפות משרד הבריאות
ההרצאות ינתנו בעברית

Seminar program:

Duration Topic Speaker
13:30-14:00 Gathering
14:00-14:45 Overview of the different Guidance Documents
Karen Ginsbury
PCI Ltd.
14:45-15:30 MOH Approach and Expectations Rina Heimlich
MOH
15:30-16:00 The required Mindset-what does DI really mean? Karin Baer
Teva
16:00-16:30 Break
16:30-17:00 Case Study Nurit Scheinkman / Ido Abramson
Kamada
17:00-17:30 Case Study IT - computerized systems Moshe Radovitch
Tera-zon
17:30-18:30 Panel Discussion with MOH - Rachel Shimonovitch and representatives from the Industry and IT systems

Note: the program and speakers are tentative and subject to change without prior notice.

Target Audience:

Quality (QA & QC), Engineering, IT, Operations, Regulatory affairs CMC R&D

Participation Fees:
PDA members - 450 NIS
Non members - 550 NIS 

Organized & Produced by
Bioforum - Applied Knowledge Center
Golda Meir 3, Weizmann Science Park
P.O.B. 4034 Ness Ziona, Israel, 70400
Tel: 08-9313070
Fax: 08-9313071
E-mail: bioforum@bioforum.co.il
site: www.bioforum.co.il