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Medical Writing (MW)

Course No.:

MW

Course Title:

Medical Writing

Hours Total:

150 h

Credit Points:

5 ECTS

Course Type: Pflicht

Course Availability: WS, SS

Course Duration: 1 Semester

Admission Requirements:

None

Course Coordinator / Instructor:

See current list of tutors in the Learning Management System

References to Other Modules:

Please see module description

Course Description:

Medical writing is involved in the entire process during the development of a pharmaceutical product. The main focus of this course will be on the documents relevant for the conduct of a clinical trial, starting with the generation of the fundamental clinical study protocol to the final study report at the end of a clinical trial as well as the common technical document (CTD) and all relevant subdocuments necessary for compilation of the CTD.

Students will be introduced to the documents involved and will be given the opportunity to write certain documents on their own.

International guidelines and local laws have to be followed for the successful conduct of a study and for the successful submission of a dossier for marketing application.

Course Objectives and Outcome:

On successful completion of this module, students will be able to:

  • write a subject information and informed consent form
  • structure a protocol
  • describe the content of the clinical study report
  • describe the structure of the CTD
  • write a review based on 2-3 publications

Teaching Methods:

This course is taught in blended format. It consists of 120 h directed, remote learning (via recorded presentations, self-readings, and exercises), followed by 4 days of full-time, face-to-face training in form of lectures, supplemented by class discussions. Class discussions refer to the concepts being introduced and case studies.

Course Content:

1 Introduction and Overview of the World of Medical Writing

2 Guidelines for Medical Writing

3 Techniques and Skills for Professional Medical Writing and Use of Templates

4 Processes: From Initial Information to the Final Document

5 Documents for Clinical Studies: Protocol, Clinical Study Report, and Subject Information with Informed Consent Form.

6 Regulatory Documents: Investigator’s Brochure, Common Technical Documents, Summary of Product Characteristics, and Submission Documents

7 Medical and Scientific Communication

8 Documentation in Pharmacovigilance

Literature:

• ICH E6. Note for guidance on good clinical practice (CPMP/ICH/135/95)
• ICH E3. ICH Harmonised Tripartite Guideline: Structure and content of clinical study reports.
• ICH M3. Common technical document (CTD)

Prerequisites to Qualify for Assessment:

• Course evaluation

Assessment:

• Research essay, 15-20 pages (DIN A4)

Student Workload (in hours): 150

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