“I have a Ph.D. in pharmaceutical sciences and postdoc experience in Academia. However, I wish to start a career in industry. And the MDRA was the perfect course to know not just the regulations, but the reasoning and ethics behind the various rules. Healthcare is not just research but also needs compassion and stakeholder consent to make patients live better. I believe this course will be my North Star in my career. The course content is up to date and this year we have a wonderful diverse batch of classmates. The lectures are delivered by experts in various fields – pharmaceutical industry, law, Regulatory agencies, amongst others. The course structure is including detailed and practical work assignments and workshops, quizzes as well as a semester of internship It is really well thought out.”

Dr. Rajasree PH Nair MDRA 26 student

“The MDRA course impresses with its excellent lecturers, sound theoretical background and many practical examples.”

Dr. Marina Pavlidou, MDRA 26 student

“The course is flexible, allowing me to effectively manage my daily work with the studies. The MDRA will further enhance and improve my skills and knowledge in regulating pharmaceuticals and medical devices. A great opportunity to share experiences with other colleagues from various sectors of the pharmaceutical industry and competent authorities. The MDRA is an eye opener to the global regulatory landscape for medicinal products. The course is strategically designed to equip regulatory professionals with the much needed expertise and understanding to navigate the requirements of product development and market placement. MDRA lecturers have wealth of experiences from the industry and EU competent authorities. The course emphasizes the need to protect public health without hindering or delaying access to the much needed health technologies.”

Albert Pahlane Maqolo, MDRA 26 student

"The course has helped me to broaden my regulatory horizon, which helps me in my day-to-day work. I also found it helpful that both the authority perspective and the industry/stakeholder perspectives were presented. I found the transfer of knowledge from lecturers who are and have been actively involved in the development of regulatory legislation/guidelines etc. remarkable. I would recommend the programme to anyone wishing to enhance their regulatory knowledge."

Jessica Jeschke / Graduate

„The postgraduate master’s course helped me to deepen my knowledge about medicinal products with regard to authorisation and the therewith associated regulatory affairs. Due to the high interdisciplinarity of the lecturers as well as the students, an understanding of the different perspectives concerning specific topics was given to me."

Dr. Patrick Jim Küppers / Student

„I joined the MDRA Master's program to expand and refine my skills in the field of regulatory affairs. The comprehensive nature of the program has proven invaluable in enhancing my daily work and fostering effective communication within various interdisciplinary teams. The program has integrated perfectly into my professional career and allowed me to build a valuable network."

Alexander Reichenbach / Graduate

„With its high quality of experts, speakers, lectures and contents, the master's program “Drug regulatory Affairs” is rightly one of the most renowned training and further education courses in regulatory affairs. Even today, I still refer to the documents in my day-to-day work and have access to a comprehensive network. The MDRA master's program was a milestone which expanded my professional expertise and significantly advanced my professional career.
Also in my team, MDRA graduates have a privileged position in an application process as I know about the outstanding training quality and therefore appreciate it all the more."

Dr. Stefanie Rodler / Graduate

„The degree programme offers a solid foundation in the field of drug and medical device authorisation and has so many facets that everyone can find what they are looking for here, whether it's a new career start, exploring new interests, deepening existing knowledge or expanding their network. For me, there was a bit of everything. Challenge included. So the decision to do the MDRA programme was a good one!"

Dr. Anya Staal geb. Kalayda / Graduate

„After many years of working in the field of pharmaceutical development, I have developed my focus of activity in the direction of quality assurance and life cycle management. I chose this further development into the formal pharmaceutical area because I realized that the correct handling of so-called "formalities" and the correct understanding of regulatory contexts is at least as important for the development and market approval of medicinal products as an understanding of the scientifically dominated development phases of the medicinal products. I was looking for a postgraduate course in order to be able to deal with the complex and highly interdisciplinary regulatory environment as comprehensively as possible. I chose the Drug Regulatory Affairs Master's program at the University of Bonn because the curriculum covers the entire regulatory spectrum. The knowledge and experience I gained there were a great enrichment for my professional career. I also learned how versatile a career can be with a regulatory affairs background. The course content still helps me today to see the big picture and recognize connections in my day-to-day work at the medicines manufacture’s association.”

Dr. Fatima Bicane / Graduate and module leader module 8 "Chemical Pharmaceutical Documentation"

„In the “Benefit, Efficiency and Reimbursement” module, we look at the path of a drug from a different perspective, namely that of the German Social Code Book V. Speakers from the Federal Ministry of Health, the Federal Institute for Drugs and Medical Devices, the Federal Joint Committee, IQWiG, regional associations of Statutory Health Insurance Physicians, the arbitration board for drug pricing and experienced lawyers present the variety of control instruments in the provision of drugs. This often leads to lively and exciting discussions with the students.”

Prof. Dr. Eva Susanne Dietrich / Module leader module 11 "Benefit, Efficiency, Reimbursement"

„Regulatory Affairs requires interdisciplinary and strategic thinking as well as a great deal of experience. With over 100 lecturers from various areas or expertise and institutions, the MDRA programme teaches exactly that. For myself, the MDRA programme has opened doors in my career, broadened my horizons, and created a great network. Over the past 10 years, I am delighted for the opportunity to pass on my own expertise and experience as a lecturer and head of module."

Dr. Niels Krebsfänger, MDRA, MBA, ERT, DABT, Specialist toxicologist (DGPT) / Graduate and module leader module 4 "General Aspects of Module 1 (CTD), Registration of Special Medicinal Products" and lecturer module 9 "Pharmacology and Toxicology Documentation"

“I am committed to the MDRA since 22 y now. This speaks for itself. As an employer we can recommend this course to students and RA professionals as a training that teaches the fundamental knowledge of working in Regulatory Affairs and interacting with Health authorities worldwide. It is a unique opportunity to learn this so comprehensively. If you train on the job, it takes quite some time to experience all this what you learn here in one go. The knowledge your employees can gain here and bring back into your company will definitely boost the way how you interact with Health authorities in future. This course helps to develop the regulators affairs managers of the future and I am convinced many of those graduating will have a great future in Regulatory Affairs.“

Dr. Max Wegner, Head Regulatory Affairs Bayer AG Pharma / lecturer module 3 “International Registration Procedures”

 „Drug Regulatory Affairs is much more than just ‘authorisation of medicinal products’. In our English Master's degree programme, which is addressing continuing education and which has been running for over 25 years, our highly qualified team of more than 100 (!) lecturers provides a comprehensive overview of the life cycle of medicinal products - from development, approval and reimbursement to pharmacovigilance and maintenance of approval. A deep understanding of the complex interfaces, strategic aspects, legal contexts and their critical evaluation is created. Participants in our English study programme are part of our network and qualify for further career prospects.“

Prof. Dr. Werner Knöss, Director of Master's degree programme and module leader of module 7 „Quality Management“

 
Our graduates talk about their studies, work and how it fits together: