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Organised by Karen Ginsbury
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| Topic |
Duration |
Speaker |
| Registration |
08.30 - 09.00 |
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| Welcoming Remarks |
09.00 - 09.15
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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 |
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| Approach to Quality: Risk Assessment vs Quality Manual |
11.00 - 11.45 |
Ilana Ziegelman, Teva |
| Comparability protocol |
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Einat Frydman, Teva |
| Lunch |
12.30 - 13.30 |
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| 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 |
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| 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 |
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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:
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Research and Development (know your market requirements) |
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Quality Assurance / Compliance |
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Quality Control and Laboratories |
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Manufacturing |
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Regulatory Affairs |
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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
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For more information or directions, contact Naama at BioForum Tel: 08-9409085
Fax: 08-9409086 E-mail:bioforum@bezeqint.net site: www.bioforum.org.il |
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