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Medical Writing (MW)

Modulbezeichnung: Medical Writing

Modulnummer:

MW

Semester:

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Dauer:

1 Semester

Modultyp:

Pflicht

Regulär angeboten im:

WS, SS

Workload: 150 h

ECTS Punkte: 5

Zugangsvoraussetzungen:

None

Unterrichtssprache:

Englisch

Kurse im Modul:

Workload:

Lectures: 30 h
Self-study: 90h
Self-testing: 30 h

Kurskoordinatoren/Tutoren::

Modulverantwortliche(r):

Dr. Andrea Schaefer

Bezüge zu anderen Programmen:

• N/A

Bezüge zu anderen Modulen im Programm:

• Drug Development
• Conducting Clinical Trials
• Statistical Thinking for Clinical Trials

Qualifikations- und Lernziele des Moduls:

This course is a thorough introduction to medical writing in which students learn about the variety of documents required throughout the development, marketing authorization, and post marketing periods of pharmaceutical products. Regulatory requirements for certain relevant documents will also be presented.

Lehrinhalt des Moduls:

• Introduction and overview of the world of medical writing
• Guidelines for medical writing
• Techniques and skills for professional medical writing and use of templates
• Processes: From initial information to the final document
• Documents for clinical studies: Protocol, clinical study report, and subject information with informed consent form
• Regulatory documents: Investigator’s brochure, common technical documents, summary of product characteristics, and submission documents
• Medical and scientific communication
• Documentation in pharmacovigilance

Lehrmethoden:

See the contributing course outline(s)

Literatur:

See the contributing course outline(s)

Anteil der Modulnote an der Gesamtabschlussnote des Programms:

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Prüfungszulassungsvoraussetzung:

Abschlussprüfungen:

See course outline(s)

Research essay, 15-20 pages (DIN A4), 100%