Descrizione della formazione

Certificate of Advanced Studies (CAS) ist eine Nachdiplomausbildung der Hochschulen und entspricht mindestens 10 ECTS-Punkten. Dieses CAS verlangt 15 ECTS-Punkte.

Regulatory Thinking (RT) is a methodological thinking approach to ensure translation of research and development into clinical solutions. It considers interests of the various stakeholders, e.g., health authorities but also patient interests. The main topics of the CAS are: Regulatory World; Regulatory Thinking; Road Map; Development Process: Pre-??clinical; Production (GMP); Development Process: Clinical; Approval / Post Market Activities; Success Factors.

Modules:

The CAS ETH in Regulatory Thinking consists of 8 modules:

• Regulatory world
• Regulatory Thinking
• Intended Use/Indication
• Development Process: Preclinical
• Production: Good Manufacturing Practice (GMP)
• Development Process: Clinical
• Approval/Post Market Activities
• Success factors

Piano di formazione

1 ECTS-Kreditpunkt entspricht einem Aufwand von 25-30 Arbeitsstunden.