Personal Details

- Die Bedeutung der Biotechnologie verstehen

- Onboarding

- Motivation und Zielsetzung

- Aufbau eines starken Fundaments in Schlüsselkompetenzen

- Karriereerkundung und Networking

- Ethische Überlegungen und aufkommende Trends

- Teil einer Community of Practice werden

Vortrag, Einzel- und Gruppenarbeit, Praktische Umsetzungsaufgaben, Selbsteinschätzung durch Übungen zur Selbst-Reflexion und individuellen Anwendung, Praxisübungen mit Feedback und Analyse

Immanente Leistungsüberprüfung

Leistungsüberprüfung (z.B. Präsentation, Diskussion, schriftliche Arbeit, Reflexion)

- Classes of Pharmaceuticals (biopharmaceuticals and small-molecule drugs)

- Case studies: Clinical development of selected drugs

- Clinical drug development process

- Selected aspects of drug discovery and preclinical development

- Overview clinical study designs, outcomes and inclusion/exclusion criteria

- Randomized Controlled Trials (RCTs): Randomization, Blinding and Placebos

- Epidemiological study designs

- Conduct of clinical trials, data analysis and interpretation

- Ethical aspects, the origins and principles of Good Clinical Practice (GCP)

- Regulatory bodies, international regulations (EMEA, FDA, ICH)

- Phase IV/Post-marketing surveillance, life cycle management

- Interfaces: Regulatory Affairs and Pharmacovigilance, Marketing and Product Life Cycle Management

- Special chapters: Advanced Therapy Medicinal Products (ATMPs), repurposing, special populations

- Lecture with structured exercises

- Dialogue and discussion

- Group work

- Blended learning

- Guest lectures

Endprüfung

Exercises during class, exam

- Knowledge Management: Definitions, R&D focus, human and data perspectives, tools, and practices.

- Innovation Management: From invention to innovation, strategic processes, and implementation.

- Business Plan Development:

- Vision, market analysis, financials, legal aspects, implementation planning.

- Four phases: idea, feedback, testing, launch.

- Key Tools: Porter's 5 Forces, SWOT, life-cycle analysis, Canvas Model, risk analysis.

- Lecture

- Dialogue and discussion

- Group work

- Supervised distance learning

- Self-study

- Project work

Endprüfung

Presentation of the group work, documentation of the group work either in Word or Powerpoint