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Medical Writing (MW)

Module Title: Medical Writing

Module No.:

MW

Semester / Term:

--

Duration:

1 Semester

Module Type(s):

Pflicht

Regularly offered in:

WS, SS

Workload: 150 h

Credit Points: 5

Admission Requirements:

None

Language of Instruction:

Englisch

Contributing Courses to Module:

Workload:

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

Course Coordinator(s) / Tutor(s):

Module Director:

Dr. Andrea Schaefer

References to Other Programs:

• N/A

References to Other Modules in the Program:

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

Qualification and Educational Objectives of the Module:

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.

Course Content of the Module:

• 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

Teaching Methods:

See the contributing course outline(s)

Literature:

See the contributing course outline(s)

Percentage of the Module Grade Relative to the Final Grade for the Program:

--

Prerequisites to Qualify for Assessment:

Assessment:

See course outline(s)

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