A ONE-DAY SEMINAR on

Stability Tsting of Pharmaceuticals

Monday, October 22, 2007, 09:00 – 16:00h
Lev-Hacongressim , Ness Ziona

Organized by Dr. Raphy Bar and Rina Yamin

    Program:

Duration	Topic	Speaker
09:15 – 09:30	Opening Remarks	Rina Yamin (cts) Dr. Raphy Bar, PDA President
09:30 – 10:00	Stability Regulations - Status Update	Dr. Mimi Kaplan MOH
10:00 – 10:30	Stability of Adrenaline Ampoules: Case study	Dr. Ilana Schumacher IDF
10:30 – 11:00	Impurities Identification on Drug Products Stability Studies Profiles by LC-MS	Dr. Bianca Avramovitch Teva-Jerusalem
11:00 – 11:30	Coffee Break
11:30–12:00	Impurities from Drug-Excipients interactions	Dr. Dror Wohlfeiler Teva
12:00 – 12:30	Leachables in a drug product	Dr. Berta Yosefson Teva-Jerusalem
12:30 – 13:00	Stability of a Biotech product	Yaron Ramati Omrix
13:00 – 14:00	Lunch
14.00 – 14.30	Identification of Out-of-Trend Stability results	Dr. Raphy Bar PDA President
14.30 – 15.00	Logistics of Drug Stability: Organization, Implementation and Monitoring stability studies	Naomy Rohald Teva-KS
15.00 – 15.30	Coffee Break
15.30– 16.00	Panel discussion	Seminar Speakers

         WHO SHOULD ATTEND?

• Analytical chemists and laboratory technicians in QC and R&D laboratories in pharmaceutical companies, who monitor the stability of drug substances (APIs) and drug products
• QA and RA personnel involved in auditing and reviewing stability data.
• Pharmacists and formulators who want to understand the stability behavior of the drug product.
• Anyone who wants to be updated on the recent regulatory status and the current practice related to the issue of stability programs of drug substances and products

           Presentations will be in Hebrew

for map please click here