Medical communications (MedCom)2.5 ECTS
(englische Bezeichnung: Medical communications)
Modulverantwortliche/r: Miyuki Tauchi-Brück
Lehrende:
Miyuki Tauchi-Brück
Start semester: |
WS 2017/2018 | Duration: |
1 semester | Cycle: |
jährlich (WS) |
Präsenzzeit: |
30 Std. | Eigenstudium: |
45 Std. | Language: |
Englisch |
Lectures:
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Medical communications
(Vorlesung, Miyuki Tauchi-Brück, Tue, 15:00 - 16:30, Seminarraum - TRC; starting 24.10.2017; Please note that the first meeting takes place in the SECOND week of the lecture period. Restration via Email required/Anmeldung per Email erforderlich: miyuki.tauchi@uk-erlangen.de)
Inhalt:
Advancement in medicine is a huge collaborative work involving physicians, patients, medical professionals, engineers, scientists, and authorities to name a few. To promote and ease the development, there are rules and regulations to follow that enable interdisciplinary groups work together. Skills and knowledge for the entire structure in medical development belong to “medical communications”.
This lecture is to introduce “medical communications” to undergraduate and graduate students with medicine-related majors. The contents include physicians-patients and researchers-authorities communications in relation to pre-clinical and clinical studies.
The focus of the lecture is on clinical studies. Published articles in medical journals, regulatory documents, and/ or websites from different organizations will be used as study materials and active participation of students is expected.
1. Clinical studies
1a. Phase 0-IV clinical studies for a new drug
Study designs/ terminologies
Objective of studies in each phase
Different study designs for different objectives
Subjects
Ethical issues in clinical studies
Key statistics often used in clinical studies
1b. Clinical study for medical devices
Classification of medical devices
2. Communications
2a. Formality
Guidelines from International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Regulations in studies with animal subjects (preclinical studies)
European legislation
Regulations in studies with human subjects (clinical studies)
Arzneimittelgesetz (AMG)Sechster Abschnitt: Schutz des Menschen bei der klinischen Prüfung
Declaration of Helsinki
Good Clinical Practice
Requirement for drug approval
Requirement for CE marking of medical device
2b. Publication
Journals: Manuscript writing/ reading
Guidelines: CONSORT, STROBE, CARE, ARRIVE, etc
Terminologies: MedDRA
Conferences: Oral/ poster presentation
2c. Patients and publication ethics
Patients’ information/ informed consent
Who are patients?
What patients want to know:
Information source for patients
Lernziele und Kompetenzen:
The aim is to let the students:
Understand the structures and designs of clinical studies, including drugs and medical devices;
Be aware of ethical issues in clinical studies;
Find problems and solutions in patient-physician communications;
Practice soft skills used in medical communications, including “skimming and scanning” journal articles in unfamiliar fields, summarizing, writing, and presenting data.
Bemerkung:
About the lecturer: Miyuki Tauchi, Ph.D.& D.V.M., Deputy head at the laboratory for molecular and experimental cardiology, Medizinische Klinik 2 (Kardiologie und Angiologie), Universitätsklinikum Erlangen; and Freelance medical / scientific writer
Verwendbarkeit des Moduls / Einpassung in den Musterstudienplan:
Das Modul ist im Kontext der folgenden Studienfächer/Vertiefungsrichtungen verwendbar:
- Medizintechnik (Master of Science)
(Po-Vers. 2013 | TechFak | Medizintechnik (Master of Science) | Grundcurriculum für alle Studienrichtungen | M1 Medizinische Vertiefung | M1 Medizinische Vertiefungsmodule)
Studien-/Prüfungsleistungen: