Prof. Dr. Gerhard Fortwengel

• Doctoral studies at the Institute for Medical Law, Human resources and Health Politics at the University for Health Sciences, Medical Informatics and Technology, Hall/Tyrol, Austria  (PhD/Dr. sc. hum.)
• Master studies in Clinical Research Methodology at the School of Pharmacy and Chemistry John Moores University Liverpool, UK, (Master of Science ? MSc)
• Master studies in Health Sciences at the University Bielefeld, Germany (Master of Public Health - MPH)
• Advanced Studies in Information Management at the University Kassel, Germany, (Diploma)
• Studies in Biomedical Documentation at the University of Applied Sciences and Arts Hannover, Germany (Academic degree BA-equivalent)
• Nursing qualification

• Since 03/2010 Professor at the University of Applied Sciences and Arts, Hannover, Germany
• 09/2009 Appointment as Professor for Clinical Research and Clinical Trial Management at the University of Applied Sciences and Arts, Hannover, Germany
• 12/2002  Director, Head of Quality Systems at Actelion Pharmaceuticals in Allschwil, Switzerland
• 01/1998 Head of Clinical Quality Assurance at Chiron Vaccines for the research locations in Marburg, Germany, and Siena, Italy
• < 1998>

Basics in Epidemiology (lecture)

- How many people have heart attacks each year?

- Do workers in chemical companies have an increased risk of developing cancer?

- What is the relationship between poverty and mental health?

These are typical questions in epidemiology? The lecture covers cover the different areas of epidemiology, types of studies, key metrics and their significance, and possible bias and confounding factors.

International Summer Program in Clinical Research and Epidemiology (lecture with practical assignments) ? Mid May to end of June ? Full day course

International students of the life sciences or related fields of study will receive an introduction to clinical research. The content will be based, apart from the purely operational side of the topic, primarily on regulatory and ethical aspects.

Project Study Course (practical course)

The Germany-wide Multiple Sclerosis Registry is about to implement requirements as outlined in the EMA Initiative for Patient Registries aiming to optimize and facilitate the use of patient registries for benefit-risk evaluations of medicinal products in the European Economic Area (ref. Report on Multiple Sclerosis Registries - Workshop 7 July 2017).

During the project study, students are involved in project plan writing, project management and operational development and implementation of an E-CRF module, including its validation and piloting.

Monitoring of Clinical Trials (seminar with practical assignments)

This practical course defines the role of the clinical research monitor and explains the interaction with others in key roles as part of the clinical trial process as well as exploring the more complex aspects of clinical trial monitoring. Guidance will be given on best practices for selecting investigators, conducting monitoring visits and safety reporting. Students will explore strategies for dealing with common clinical trial management issues and how to adopt a preventative approach to handling monitoring issues.

Protocol Development for Clinical Research (seminar with practical assignments)

Course content includes: different meanings of the term ?protocol?; how to communicate the value of planned research; what are the right characteristics of a good research question; how to match the research question to an appropriate study design; guidelines for writing a protocol; key features of ICH GCP E6 and SPIRIT guidelines for reporting clinical trial protocols; how to prepare a real study protocol outline.

UNIT HISTORY

We got recognition as a UNESCO unit of the international network, the UNESCO chair in bioethics in June 2015. This recognition is awarded to academic research institutions, particularly the care of the training and application of medical ethics in theory and practice.

 OUR FOCUS

We work in the areas of medical research in developing countries from the standpoint of ethical, legal, socio-economic conditions.  

One of the current research is the development of drugs in the so-called low-income countries, to check whether the patients participating in the studies of the pharmaceutical industry, will also benefit from the results of this research by a subsequent marketing approval of new drugs in their countries.

We have ongoing research projects in Nigeria, Sudan, Cameroon, India and USA.

Prof. Dr. Gerhard Fortwengel

Unit head UNIRED and Professor at Hochschule Hannover, Germany.http://www.unesco-chair-bioethics.org/