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Studium
Biotech, Pharma & MedTech Management
NeuZertifikat, 2 Semester, berufsbegleitend
Assoz.-Prof. Dr. Jens Hartmann, Studienleitung - Department für Biomedizinische Forschung, Jens Hartmann Studienleitung
Krems, AT, Universität für Weiterbildung Krems, Dr.-Karl-Dorrek-Straße 30, 3500
Module, Das Certificate Program "Biotech, Pharma & MedTech Management" bereitet Sie auf die Besonderheiten des strikt regulierten Healthcare Marktes und dessen kompetitiven internationalen Umfelds vor. Es besteht aus vier Modulen à vier Tagen im Blended Learning Format. , Health Care Markets, Health Care Markets I Health Care Markets II Compliance & Governance Supply Chain Management , 6.0, Quality and Regulations, Quality Management & Lean Management Intellectual Properties Management Regulatory Affairs GMP/GLP/GDP/GCP , 6.0, Digital Transformation and R&D, Digitalization in Health Care Big Data Management and Precision Medicine R&D Strategies Technology Transfer , 6.0, Innovation and Market Access, Innovation New Business Models Approaches to Financing Dealmaking & Negotiations , 6.0
Zertifikat, 2 Semester, berufsbegleitend
Das Programm richtet sich an Regulierungsfachleute, die ihre Karriere auf dem Gebiet der EU-Registrierung von Arzneimitteln und Medizinprodukten vorantreiben wollen, und umfasst auch verwandte Bereiche wie Nahrungsergänzungsmittel, Kosmetika und Tierarzneimittel., Salma Michor PhD, RAC, Managing Director and Global Unit Head Regulatory Affairs
QBD GROUP AUSTRIA, Salma Michor
Examination subjects, EU Regulatory Affairs, CP, Introduction to Regulatory Affairs, , 4.0, Drug Regulatory Affairs I, (Pre-market requirements, types of applications, types of registration procedures, data requirements) , 5.0, Drug Regulatory Affairs II, (Medicinal Product post marketing & compliance) , 5.0, Medical Device Regulatory Affairs I, (Medical device pre-market requirements, Conformity Assessment and Notified Bodies) , 5.0, Medical Device Regulatory Affairs II, (Medical device post marketing & compliance) , 5.0, Pharmaco-economics and Decision- Analytics, (Benefit of drugs, Cost-Benefit Analysis, Value Dossiers, Market Access, Efficiency and Effectiveness, Admission Strategies) , 5.0, choose two of the options, Special Topics in Regulatory Affairs, Generics, Orphan drugs, Cosmetic products, Food supplements, Veterinary medicinal products, OTC products, advertising & promotion , 5.0, Quality management and compliance, Quality systems, enforcement and national authorities , 5.0, Clinical Trial management, Drugs and devices , 5.0, Biotech, plasma and blood products, Biotech products, Human tissue regulation, Products from human blood/plasma, biosimilars , 5.0
MBA
Spezialisierung Biotech, Pharma & MedTech Management
Master of Business Administration, 4 Semester, berufsbegleitend
"Ich habe hier eine weitere Sprache gelernt.", Dr. Christoph Zaba, MBA , Absolvent MBA Biotech, Pharma & MedTech Management, Director Global Product Management - Fresenius Medical Care, Christoph Zaba