Operational Management & Ethical Implications Workshop 22- 23, November 2017

In collaboration with Hannover University of Applied Sciences and Arts (HsH), Germany, the Mycetoma Research Center (MRC) and the National Center for Research (NCR), Khartoum, Sudan had conducted an Operational Management & Ethical Implications training workshop. It was organised at Soba Education, Training and Examinations Center in the period 22nd and 23rd of November 2017. 37 participants from different universities and research institutes had attended the workshop.

Prof. Gerhard Fortwengel, PhD, MPH, the Head of German Unit of UNESCO International Network of Bioethics Chair, Professor of Epidemiology, Faculty of Media Design and Information at Hannover University of Applied Sciences and Arts (HsH), Germany had facilitated the workshop. It was a two day-interactive workshop. The sessions involved Good Science as Basis for GCP, Statistical considerations, exploratory and confirmatory research, History of Clinical Trial Legislation, CFR, Helsinki Declaration, ICH, Regulatory Bodies and Ethical Issues.

Prof. Ahmed Hassan Fahal, Director of Mycetoma Research Centre and Prof. Ahmed Modawi Musa, Director of the Institute of Endemic Diseases had presented their experiences with Mycetoma clinical trial and Institute of Endemic Diseases clinical trials, respectively.

By the end of the first-day prof. Gerhard had visited the Mycetoma Research Center where he was welcomed by Prof. Ahmed Hassan Fahal and the MRC team. He then went on tour through the centre department that included the MRC’s Laboratory, and he was introduced to the many new diagnostic tools for Mycetoma diagnosis. He then continued the tour to visit the out-patient department, library, museum and the pharmacy. During the visit, Prof. Gerhard was given more detailed information about the undergoing clinical trial which is a randomised, double-blind, phase II, proof-of-concept superiority trial of fosravuconazole 200 mg or 300 mg weekly dose versus Itraconazole 400 mg daily dose, all three arms in combination with surgery, in subjects with eumycetoma in Sudan.