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Syllabus Pharmaceutical and biotechnology products development compliant with regulatory requirements - 71174
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Last update 25-01-2024
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 Email: moshe@brd.co.il

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:
 
Students needing academic accommodations based on a disability should contact the Center for Diagnosis and Support of Students with Learning Disabilities, or the Office for Students with Disabilities, as early as possible, to discuss and coordinate accommodations, based on relevant documentation.
For further information, please visit the site of the Dean of Students Office.
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