Drug Shortages in Germany - A Critical Assessment.

Dr Ralf Hess, Dominik M. Aumer, Moritz Haucke and Dr Simon Schulz publish articles on drug shortages and their causes in RAPS.

Together with the two Managing Partners of Entourage, Dominik M. Aumer and Moritz Haucke, our Management Consultants Dr Ralf Hess and Dr Simon Schulz have published an article on the drug shortage and its causes in the Regulatory Affairs Professionals Society.

From the perspective of a medium-sized generic drug manufacturer, the article analyses the causes of the drug shortage in Germany and the causes of production problems at active ingredient and drug manufacturers. Measures to limit damage in a "broken marketplace" are discussed and in the epilogue, the current COVID 19 pandemic is discussed and a warning is given that medicines and active ingredients from China and India could become scarce due to the disruptions caused by the pandemic.

You can find the article under the following link.

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Persons to the article.

Moritz Haucke

Member of the Board of Directors

Moritz Haucke, M.A. is the founder and Managing Partner of Entourage GmbH. He studied Information Science, Business Administration and Philosophy at Saarland University and looks back on many years of experience in HR consulting.
For a leading Anglo-Saxon recruitment company, Mr. Haucke successfully built up new markets in German-speaking countries and was subsequently responsible for the pharmaceutical sector for the D/A/CH region. Accordingly, he has excellent knowledge of GxP-regulated markets and an excellent network of experts and decision-makers within the pharmaceutical industry.
Moritz Haucke is Managing Director of Entourage GmbH and member of the Board of Directors of Entourage Pharma Consulting AG.

Dominik M. Aumer

Member of the Board of Directors

Dipl.-Kfm. Dominik M. Aumer is an independent management consultant and founder of Entourage GmbH. He studied business administration at Saarland University and looks back on more than ten years of experience in strategic consulting and human resources development.
Mr. Aumer has deep knowledge in sales-related personnel and organisational development and an excellent network to decision makers and experts in the service industry. With the process-based method of Sales Process Consultancy that he developed, he designed scientifically sound concepts for sales personnel development as a consultant to sales organisations. In 2013 he was also voted one of the Top 100 Trainers Excellent in Germany.
Dominik M. Aumer is Managing Director of Entourage GmbH and a member of the Board of Directors of Entourage Pharma Consulting AG.

Dr Ralf Hess

Principal Management Consultant

Dr Ralf Hess studied biology at the Albert-Ludwigs-University of Freiburg and received his doctorate at the Institute of Virology. Dr. Hess has many years of experience in the development of medical devices and medicinal products as well as their combination, in laboratory analytics and their quality assurance. The quality expert has established, implemented and maintained QM systems according to ISO and GxP for various application areas. The customer service portfolio ranges from manufacturers of classical and biological drugs, medical device companies and vaccine manufacturers to immunohistochemical, immunological, molecular biological and serological diagnostic laboratories. Dr. Hess is active worldwide as an auditor in the GxP/ISO area and has many years of experience in FDA remediation projects and the regulatory development of combination products (drug device products).
Dr. Ralf Hess supports Entourage as Principal Management Consultant.

Dr Simon Schulz

Management Consultant

Private lecturer Dr. rer. nat. Simon Schulz received his diploma in chemistry from the Ruprecht Karls University of Heidelberg, where he also received his doctorate at the Institute of Physical and Biophysical Chemistry in 2009. In 2016, he habilitated in experimental medicine at the University Medical Centre Freiburg.
Dr Schulz has many years of experience in GLP compliance and computer validation as well as the development and testing of medical devices. He has extensive expertise in the compliance of medical devices with ISO 13485 and FDA 483 according to 21 CFR 820 and the development of SOPs for their manufacturing process. Furthermore, he has distinct competence in CAPA management, complaint handling and process validation.
Dr. Simon Schulz supports Entourage as a management consultant.

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