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HU Credits:
2
Degree/Cycle:
2nd degree (Master)
Responsible Department:
School of Pharmacy
Semester:
1st Semester
Teaching Languages:
Hebrew
Campus:
Mt. Scopus
Course/Module Coordinator:
Zohar Yahalom, Adv.
Coordinator Office Hours:
Thursday, 10.00-11.00
Teaching Staff:
Zohar Yahalom
Course/Module description:
Introduction of the regulation of the pharmaceutical industry in Israel and abroad
Course/Module aims:
Acquaintance with the basic principles and terminology of pharmaceutical regulation in Israel and abroad
Learning outcomes - On successful completion of this module, students should be able to:
Analyze basic questions related to the pharmaceutical regulation
Attendance requirements(%):
required
Teaching arrangement and method of instruction:
Frontal Presentation
Course/Module Content:
1. Regulatory definition and classification of medicinal products.
2. Registration of Medicinal Product and its exemptions.
3. Clinical trials.
4. Regulation of pharmaceuticals’ manufacturing, distribution, dispensing and importation.
5. Pharmacovigilance.
6. Pharmaceuticals’ chain of supply.
7. Drug Information
and Pharmaceuticals’ advertisement.
8. Pricing and Reimbursement.
9. Pharmaceutical Companies and HCPs interactions.
10. Enforcement and surveillance in the pharmaceutical market.
Required Reading:
petition to the High Court
30/82,70/80.1405/14,4675/03
Additional Reading Material:
Course/Module evaluation:
End of year written/oral examination 100 %
Presentation 0 %
Participation in Tutorials 0 %
Project work 0 %
Assignments 0 %
Reports 0 %
Research project 0 %
Quizzes 0 %
Other 0 %
Additional information:
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