Organised by Karen Ginsbury

08.30 - 09.00
Welcoming Remarks
09.00 - 09.15
Karen Ginsbury
Ministry of Health Perspective and Update on PIC/S membership
09.15 - 10.00
Dr. Rachel Karpel, Ministry of Health
Post approval CMC changes in registration (type I, type II vs CBE etc.)
10.00 - 10.30
Veronique Bellaiche, Teva
Coffee Break
10.30 - 11.00
Approach to Quality: Risk Assessment vs Quality Manual
11.00 - 11.45
Ilana Ziegelman, Teva
Comparability protocol

11.45 - 12.30

Einat Frydman, Teva
12.30 - 13.30
Comparison of Pharmacopeial Requirements (USP, BP, Ph. Eur) for QC testing
13.30 - 14.15
Miriam Getsis, Taro
Cleanroom regulations
14.15 - 15.00
Karin Baer, Omrix
Coffee Break
15.00 - 15.30
Non-sterile dosage forms requirements
15.30 - 16.15
Karen Ginsbury, PCI
Comparison of EU vs FDA Inspection approaches: from the factory floor
16.15 - 17.00
Benny Klener, Teva

Who should attend:

This promises to be a unique seminar addressing aspects of regulations, manufacturing, Quality Assurance as well as research and development. The seminar is not to be missed and is suitable for participants from the following disciplines:

Research and Development (know your market requirements)

Quality Assurance / Compliance
Quality Control and Laboratories
Regulatory Affairs
All those involved in managing, preparing for or participating in regulatory inspections

Participation Fees:

590 NIS for PDA members
840 NIS for new members including electronic international PDA membership
1040 NIS for new members including full international PDA membership

For more information or directions, contact Naama at BioForum Tel: 08-9409085
08-9409086 site: