HU Credits:
2
Degree/Cycle:
2nd degree (Master)
Responsible Department:
Biotechnology
Semester:
2nd Semester
Teaching Languages:
English
Campus:
Rehovot
Course/Module Coordinator:
Dr. Moshe Neuman
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 phase, in order to support filing of registration product files for review and approval by the authorities.
Attendance requirements(%):
80%
Teaching arrangement and method of instruction:
Frontal instruction
Course/Module Content:
• Introduction to regulatory affairs and regulation of medicinal products, overview of the global perspective
• The development path for a drug/ biotechnological medicinal product
• The regulatory umbrella - the international ICH guidelines and other published information by the FDA in the USA and the EMA in the European Union for drug/biotechnological medicinal product development
• The Food and Drug Administration (FDA) in the USA - structure, authorities and the legal basis for drug approval process
• Classification of medical products, the basis for choosing the required development path - guiding principles and definitions (product classification exercise)
• Introduction to IND submission - knowledge of the existing IND tracks, the structure and content of the IND application
• The information package that supports drug/biotechnological medicinal product registration file - basic principles, product characterization for a certain indication, choosing a strategic path for development
• Construction of the information package supporting the registration file - the CMC chapter, drug substance development (purity, characterization methods, specifications, stability)
• Construction of the information package supporting the registration file - the CMC chapter drug product development, formulation development, packaging development (purity, characterization methods, specifications, stability)
• Good Manufacturing Practices (GMP) requirements, during the various stages of development, GMP for investigational product (and aseptic -processing environment)
• Construction of the information package supporting the registration file - the preclinical toxicology development phase and pharmacology chapter - dose selection, MTD, pharmacokinetic profile, ADME study
• Unique topics in CMC for the development of biotechnological products and advanced therapies, GTP
• Construction of the information package supporting the registration file - clinical development, clinical trial protocol design, obtaining IRB Committee approval to conduct the trial, data collection to support product efficacy and safety claims, mandatory rules for processing clinical data
• Preliminary meeting with the FDA in the USA (Pre IND meeting)
• The structure of the harmonized CTD information package and eCTD electronic submission procedures to the regulatory authorities
• Review process of the IND by the FDA review team
• Transition from IND to submitting an NDA or BLA for product registration in the US or MAA in the EU
• Unique expedited registration tracks to speed up product approval procedures (Accelerated approval, Fast track, Breakthrough therapy, Orphan drug designation, 505 b(2))
• Development of generic products and introduction to biosimilars
• Similarities and differences in product registration by EMA in the European Union
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
Grading Scheme :
Written / Oral / Practical Exam / Home Exam 100 %
Additional information:
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