|
HU Credits:
2
Degree/Cycle:
2nd degree (Master)
Responsible Department:
Biotechnology
Semester:
2nd Semester
Teaching Languages:
Hebrew
Campus:
Rehovot
Course/Module Coordinator:
Tarryn Shuldiner-Harpaz
Coordinator Office Hours:
To be announced
Teaching Staff:
Dr. Moshe Neuman
Course/Module description:
The course includes a comprehensive review of the regulatory requirements and strategies for the development and approval of pharmaceuticals and biotechnological products (including stem cell-based advanced therapies) for marketing in the US and EU.
Course/Module aims:
Learning the principles and practice of statistics in biological research
Learning outcomes - On successful completion of this module, students should be able to:
To provide comprehensive knowledge at the practical level of the required R&D procedures, from the pre-clinical stage throughout the clinical development, in order to support filing of registration product files for review and approval by the authorities.
Attendance requirements(%):
Teaching arrangement and method of instruction:
Frontal instruction
Course/Module Content:
Required Reading:
A list of critical ICH guidelines and procedures published by the FDA in the US and EMA in the European Union will be provided
Additional Reading Material:
List of important articles will be provided
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:
|
