PDA Afternoon seminar on

SCHEDULE:

Duration Topic Speaker
15:00 - 15:30
Registration
15:30-15:45 Opening remarks Rina Yamin
PDA Chapter President
15:45-16:00 Regulatory requirements for in use stability studies Dr. Rachel Karpel
PCI Pharmaceutical Consulting Israel
16:00-16:30 In use stability studies from a regulatory point of view
The MOH draft SOP for in-use stability to be discussed in this session
Dr. Rami Kariv
Ministry of Health
16:30- 17:00 Stability and in-use shelf life studies for oral liquid formulations Dr. Vered Roseberger
CTS
17:00-17:30 Coffee break
17:30- 18:00 In-use stability studies in solid oral dosage forms Yael Rotbart Cohen
Teva
18:00- 18:30 In-use stability studies of semisolids, liquids and nasal sprays Michal Arnon
Perigo
18:30- 19:00 Panel discussion Seminar Speakers

Note: Speakers and topics were confirmed at the time of publication. However, circumstances may necessitate changes without prior notice

WHO SHOULD ATTEND?

  • QA, RA, QC and R&D personnel involved in planning and execution of in-use stability studies
  • Anyone who wants to be updated on the recent regulatory status , current practices, and Ministry of Health expectations related to in-use stability studies

Participation fees:
PDA members - 320 NIS
Non members - 400 NIS

Registration is mandatory, please register here

      For map please click here

        Free parking is available inside Machon Ayalon

 
 
Organized & Produced by
Bioforum - Applied Knowledge Center
Golda Meir 5, Weizmann Science Park
P.O.B. 4034 Ness Ziona, Israel, 70400
Tel: 08-9313070
Fax: 08-9313071
E-mail: bioforum@bioforum.co.il
site: www.bioforum.co.il