More specifically, upon completion of the course, they will understand:
- Phases of development of medicinal products including approval procedures in EU (k1)
- Importance of GMP guidelines in pharmaceutical industry (e.g. ALCOA principles, Deviations, Change Controls) (k2, k3)
- Understanding the work with industry standards (e.g. certified environmental management system (ISO 14001), corporate social responsibility (CSR standard, ISO 26000), and integrated management systems (IMS). (k4, k5)
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Students are familiar with general guidelines for the pharmaceutical industry and legally prescribed standards for quality and hygiene standards in hospitals. The lecture content includes:
- Development of medicinal products: Pre-Clinical Phase, Clinical Studies, Approval procedures for medicinal products
- Regulations for Drug Saftey/Pharmacovigilance: ADR vs AE and reporting
- Good manufacturing practice: Overview of EU GMP Guidelines with special focus on e.g. Standard operating procedures, Deviations, Change Controls
- Pharmaceutical Industry: Terms and Definitions, Compliance, Audits and Inspections
- Quality Management: ISO 9001:2015, management models, EFQM model
- Risk Management: Systemic approach including Failure Mode and Effects Analysis (FMEA)
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