Regula Furegati Hafner: Catalogue data in Spring Semester 2019

NameMs Regula Furegati Hafner
Address
Inst. f. Pharmazeutische Wiss.
ETH Zürich, HCI H 417
Vladimir-Prelog-Weg 1-5/10
8093 Zürich
SWITZERLAND
Telephone+41 44 633 74 05
Fax+41 44 633 13 65
E-mailregula.furegati@pharma.ethz.ch
URLhttp://www.postgraduate.pharma.ethz.ch
DepartmentChemistry and Applied Biosciences
RelationshipLecturer

NumberTitleECTSHoursLecturers
541-0005-00LModule 5: Pharmaceutical Development and Production
Only for CAS in Pharmaceuticals.

The enrolment is done by the CAS in Pharmaceuticals study administration.
2.5 credits3GR. Furegati Hafner, R. Schibli
AbstractStudents learn about the pharmaceutical drug development process from the analytical characterisation of drug product both for small molecules and biotechnological drug substandes. The learnings include: formulation of clinical and market form, scale-up, 2D/3D printing technology for drugs, clinical trial supply, commercial packaging, supply chain management and continuous manufacturing.
Objective• Analytical characterization of the active pharmaceutical ingredient (API)
• Drug formulation: clinical form and market form
• Analytical characterization of formulations
• Scale-up of manufacturing processes
• Clinical trial supply
• Commercial packaging
• Technical project management
• Supply chain management
• Leading pharmaceutical operational excellence
• Research trends in drug formulation and delivery
Continuing Manufacturing
541-0006-00LModule 6: Regulatory Affairs
Only for CAS in Pharmaceuticals.

The enrolment is done by the CAS in Pharmaceuticals study administration.
2.5 credits3GR. Furegati Hafner, R. Schibli
AbstractStudents learn about the regulatory aspects of drug development, about the Swiss, European and FDA regulations, regulatory information and strategies, personalizing healthcare and the role of companion diagnostics, about special regulations for biosimilars, medical devices, generics, orphan drugs, GMOs and advanced therapeutics incl. gene therapy and pharmacovigilance.
Objective• European regulations for medicinal products
• Clinical trial directives and application procedures
• Marketing authorization procedures in the EU
• FDA regulations
• Swiss authorities and regulations
• Helvetisation of regulatory documents
• Variations and change control
• Pharmacovigilance
• Regulatory aspects of packaging
• Electronic submissions
• Health economics and outcomes research
• Special regulations: Biologics, Orphan drugs, Biosimilars, Pediatrics, Generics
• How to search the web for regulatory information
541-1000-00LEssay
Only for CAS in Pharmaceuticals.

The enrolment is done by the CAS in Pharmaceuticals study administration.
1 credit2DR. Furegati Hafner, R. Schibli
AbstractThe essay is an essential part of the CAS program „Pharmaceuticals – From Research to Market“ (CAS Pharm) and serves as final performance assessment.
ObjectiveThe essay documents the student’s competence development during the program as well as the transfer of acquired knowledge to professional practice/activities.