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
|
