Current issues in Quality and Manufacturing of Biotechnology Products_13

You are cordially invited to participate in the Israel Chapter of PDA’s
Summer Event co-sponsored by the Israeli Ministry of Health

Program:

13:00	Registration and Light Lunch
13:45 – 14:00	Opening Remarks	Dr. Sigalit Portnoy President, Israel Chapter
14:00 – 15:00	Current Issues in Quality and Manufacturing of Biotechnology Products	Dr. Steven Kozlowski Director, Office of Biotechnology Products FDA
15:00 – 15:45	Issues in Process Validation of Biotechnology Products	Dr. Eli Schmell VP R&D Kamada Ltd.
15:45 – 16:00	Coffee Break
16:00 – 16:45	Issues in Investigational Biotechnology Products	Karen Ginsbury President PCI Pharmaceutical Consulting Israel Ltd.
16:45 – 17:45	Panel discussion with Questions and Answers
17:45 – 18:00	Closing Remarks

This meeting should not be missed if you are involved in:

Research and Development, Pilot manufacture, Quality Assurance, Production, Operations, OTS, Regulatory Affairs, Compliance, process validation, process optimization or conduct of clinical trials using Investigational products and in particular those produced using biotechnology.

This is an unusual opportunity and you are advised to register early as a large turnout is expected.

Fees:
800 NIS for PDA members
1,050 NIS for non-members (which includes one year’s membership)
1,250 NIS for new members including full international PDA membership

For more information contact Naama at Bioforum
Tel: 08-9409085, Fax: 08-9409086
E-mail: bioforum@bezeqint.net site: www.bioforum.org.il