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:

  • Medical directors
  • Project managers
  • Quality assurance personnel
  • RA personnel

Participation fees:
PDA members - 690 NIS
Non members - 885 NIS

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Registration is mandatory, please register here

 

 

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