Invitation to a
One-Day Seminar
on
The International harmonisation, a rapidly changing and demanding regulation and an increasing complexity of the new drugs and medicinal products have brought a major change in Drug Safety Surveillance.
Expectations and requirements are the same for a start-up and a big Pharma, and have expanded to the whole lifecycle of the products. Financial impact for non compliance could be critical for the company and the product.
Therefore the concepts, methods and tools of Pharmacovigilance must be implemented as early as possible, Safety must be demonstrated continually and Risk shall be identified and evaluated at the earliest stage. Actions must be initiated to prevent, mitigate the risk and to educate both healthcare professionals and patients
SEMINAR PROGRAM
| Duration |
Topic |
Speaker |
|
08:30 – 09:15 |
Registration |
|
09:15 – 09:30 |
Opening Remarks by the PDA President |
Dr.Mordechai Izhar
Ludan
|
|
09:30 – 10:30 |
The Pharmacovigilance Vision and its International Framework
|
Dr. Irene Fermont
ADDS |
|
10:30 – 10:30 |
Pharmacovigilance by us
|
Dr. Batya Haran
MOH
|
|
11:00 – 11:30 |
Coffee Break |
|
11:30 – 12:00 |
Pharmacovigilance at Teva |
Dr. Hedva Voliovitch
Teva |
|
12:00 – 12:30 |
Reporting of Medical Device Related Incidents to Regulatory Authorities |
Mrs. Tsvia Erlich
Contipi/NGIT |
|
12:30 – 13:30 |
Lunch |
|
13:30 – 14:00 |
The Pharmacovigilance Matrix for Small Pharma Companies |
Mr. Moshe Kamar
Private Consultant |
|
14:00 – 14:30 |
Pharmacovigilance in Biopharmaceuticals |
Dr. Sara Horn
Omrix |
|
14:30 – 15:00 |
Hands on : 10 steps to build a Pharmacovigilance System |
Dr. Irene Fermont
ADDS |
15:00 – 15:30 |
Coffee Break |
|
15:30 – 16:00 |
Panel Discussion |
Dr. Irene Fermont
ADDS |
Target Audience:
Participation fees:
PDA members - 690 NIS
Non members - 885 NIS
for map please click here
Registration is mandatory, please register here
