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
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Registration is mandatory, please register
here
