Meeting Agenda:
Speaker Speaker
15:30 - 16:00
16:00 16:15
Opening Remarks, President Dr. Sigalit Portnoy - Taro
16:15 16:25
Treasurer report Karin Baer - Omrix
16:25 16:35
Worldwide Education and Training at the PDA Gail Sherman TRI Manager - PDA
16:35 17:35
Quality and Excellence as Milestones to Daring and Innovativeness Giora Shalgi - Former President & CEO, Rafael
17:35 17:45
Hanukah Candle Lightning
17:45 18:15
Coffee Break
18:15 19:00
Discussion Groups:
Hall A
Hall B
Hall C
Hall D
Method Qualification by Phase of Drug Development
Dr. Raphy Bar - Pharmos

Process Development
Dr. Yoram Sela

Vendor Qualification
Ilana Zigelman
Life Cycle of IT Systems
Lilit Levi
19:10 20:00

Ministry of Health Discussion Groups:
Questions for the MOH Discussion Group should be submitted prior to the meeting to:

Hall A
Hall B
Hall C
Dr. Rami Kariv
GMP National Supervisor
Dr. Mimi Kaplan
Pharmaceutical Industry Laboratory Manager
Dr. Ofra Exelrod
Biological Products Unit Manager
Who should attend:

This promises to be a unique meeting addressing aspects of regulations, clinical trials, manufacturing, quality assurance as well as research and development. The meeting 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
Clinical Trials
IT Systems
All those involved in managing, preparing for or participating in regulatory inspections
Participation Fees:
1. 250 NIS for PDA members
2. 500 NIS for new members (including electronic international PDA membership)
3. 700 NIS for new members (including full international PDA membership)


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