Entourage Task Force.

Stefan Hagendorff studied process engineering at the Technische Universität Clausthal and received his diploma with an emphasis on plant engineering and energy process engineering. During his long-term function as a consultant in diverse industries, including prominent companies in the pharmaceutical industry, Stefan Hagendorff was able to acquire extensive knowledge about strategic methods. The graduated engineer has distinctive experience in business process management and process optimization. Mr Hagendorff has deep knowledge in data-based improvement methods, like Six-Sigma, process mining and machine learning and will mainly focus on the topic „digitization in the life science industry“.

Dr Ralf Hess studied Biologics at the Albert-Ludwigs-University Freiburg and earned 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 its quality assurance. The quality expert designed, implemented and maintained various QM systems according to ISO and GxP for different areas of application. The customer service portfolio varies from manufacturers of small molecules and biological medicinal products to medical device companies and vaccine manufacturers to immunohistochemical, immunological, molecular biological and serological diagnostic laboratories. Dr Hess operates worldwide as an auditor in the area of GxP/ISO and has long-time experience in FDA remediation projects as well as in the regulatory development of combination products (drug device products).

More on www.rdhess.de

Igor Tchoudovski graduated in Biomedical / Medical Engineering from the Moscow State Technical University. He received his PhD in Biomedical Engineering from the Karlsruhe Institute of Technology. In addition, Mr. Tchoudovski is a certified Project Management Professional from the Project Management Institute (PMI). In over 18 years of professional experience, Dr. Tchoudovski has worked as Head of R&D for various medical device companies. As a consultant to the leading management consulting firm, Mr. Tchoudovski was most recently active in various areas. Among others he worked in Business Transformations & Strategy, Digital Solution Development and Entrepreneurship & Business Building. Dr. Igor Tchoudovski supports Entourage as a member of the Task Force and Head of Digital and Analytics.

Privatdozent Dr. rer. nat. Simon Schulz gained his diploma in chemistry at the Ruprecht-Karls University Heidelberg, where he also graduated at the Institute for Physical and Biophysical Chemistry in 2009. In 2016 he habilitated at the University hospital in Freiburg in Experimental Medicine. Dr Schulz has many years of experience in GLP Compliance and computer validation as well as in the development and testing of medical devices. He has extensive expertise to the compliance of medical devices in ISO 13485 and FDA 483 according to 21 CFR 820 and the development of SOP’s for their manufacturing process. Furthermore, he has distinctive competence in CAPA management, complaint handling and in process validation.
Privatdozenz Dr Simon Schulz supports Entourage as Project Consultant.

Curtis Sizer studied Mechanical Engineering at the University of Colorado in Colorado Springs and Denver and obtained a project management certification.
Mr Sizer is an accomplished project manager & lead mechanical engineer with over 20 years of experience working in the medical device, mobile phone, hard drive & specialty connector industry. He has extensive knowledge in the ensuring of medical devices according to ISO 13485: DFM/DFA, DOE, IQ, OQ, PQ, V&V, in FMEA procedures (ISO 13485, 21 CFR Part 820 part 20/30), as well as in CAPA remediation, Design control changes, risk analysis (ISO 14971), in DHF development and remediation and approval.

Norbert Bleich studied Chemistry at the Albert Ludwig University in Freiburg from where he graduated with a degree.
Mr Bleich looks back on a career of over 20 years in the pharmaceutical industry and has an excellent understanding of development operations, processes, quality and change management, as well as financial controlling. Furthermore, Mr Bleich is also conversant in the local and global development of phramaceutical products. He rounds off his pharmaceutical capabilities with Clinical & Early Clinical Development, Scientific & Regulatory Writing, Global Development Operations & Finance, Biostatistics & Data Management as well as Information & Document Management.

Dr Michael Stein studied Pharmacy at the University of Tübingen and earned a PhD in Pharmaceutical Technology at the Free University of Berlin in 1987. He subsequently held a number of positions with various companies in the pharmaceuticals industry, including managerial functions, and built up extensive expertise in the field of the production and release of solids, liquids and parenteral drugs, as well as in quality management, especially auditing and logistics. He is authorised to act as a Qualified Person and is also an expert in GMP compliance and contract manufacturing (both client and contractor).

Dr Wilfried Hauke studied Medicine at Ludwig Maximilian University in Munich and earned his doctorate in Frankfurt in 1991. Dr Hauke has been active in the pharmaceuticals industry for over 30 years, holding positions of responsibility for the clinical development of small molecules and biologics. As a Qualified Person for Pharmacovigilance, Dr Wilfried Hauke has in the course of his professional career assumed tasks as a pharmacovigilance manager for companies operating in Germany and has also focused on risk-benefit analyses within the scope of due diligence processes, as well as on rare disease/orphan drug development. Dr Hauke rounds off his profile with consultative roles and as an interim manager

After taking a first degree in Biomedical Engineering at the Technical University in Berlin, Arne Briest earned an MBA in Healthcare at the Steinbeis University in Berlin.
In the course of his career, Mr Briest has gained experience in the development and implementation of regulatory strategies in the USA, the EU, Canada, Brazil and China, as well as the implementation of quality management systems in compliance with ISO 13485 and 21CFR820 (QSR). Furthermore, as an interim Regulatory Affairs and Quality Assurance manager Mr Briest is conversant with software-driven dermal fillers, orthopaedic and active implementable devices.

Dr Peter Riechel studied Chemistry, majoring in Technical Chemistry at the University of Hanover and afterwards worked as a research associate in the fields of medical physics and biophysics and technical chemistry at the Universities of Applied Sciences in Münster and Hanover. Dr Riechel has many years of experience in the pharmaceuticals and medical technology industries, with a focus on quality management, quality systems, as well as quality control and analytical development. His core competences lie in the areas of escalation and recall management, CAPA, Six Sigma, project management and root cause investigation in international and interdisciplinary teams. Dr Riechel is also a certified lead auditor for medicinal products in accordance with ISO 13495 and ISO 9001.

Dr Petra Heyen studied Medicine at the University of Münster in Westphalia, where she earned her PhD in Medical Informatics in 1988. The regulatory affairs expert followed up with advanced studies in Public Health, Regulatory Affairs, Pharmaceutical Medicine and Health Economics. Ms Heyen can look back on many years of experience in the areas of global regulatory affairs, drug safety and quality and has a high level of operational and strategic experience gained in various managerial positions. Her core competences lie in the fields of interface management, due diligence, strategic, tactical and operational aspects of regulatory, drug safety and quality systems, as well as in developing new and adapting existing organisational units in these areas.

Dr Christoph Tobias Berger studied Pharmacy at Christian Albrecht University in Kiel and graduated from there in 1994 with the qualification of Dr. rer. nat. in Dosage Form Development. The graduate Doctor of Pharmacy also has a management qualification. Dr Berger has many years of experience as a production manager and laboratory manager in the fields of quality assurance and galenics, and as a technical director and Qualified Person pursuant to Section 15 (3a) of the German Medicines Act (AMG). His core competences lie in the fields of tech transfer, supplier auditing and exercising the role of QP for pharmaceutical companies.