CTD - CMC handling: A guide to content and format

Senior Manager, Regulatory Affairs CMC Team leader for pharmaceutical quality, with many years of experience in pharmaceutical quality and maintenance (primarily generics).
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CMC Expert Operations

A. F. Bick is a specialist pharmacist for public health and a state-certified food chemist. In 2021, he also completed his Master of Drug Regulatory Affairs degree. After working in various roles as a pharmacist in the German Armed Forces, he has been employed by a government agency since 2019, where he is responsible for the validation of national and European variations.

Consultant, Owner After completing his studies in pharmacy, Dr Kühnle held various positions in the CMC and RA departments at Teva ratiopharm. His main areas of focus included the creation and consolidation of modules 2.3 and 3, as well as the coordination of interface issues between R&D, QA, CMC, and RA. This was followed by positions as team leader for Non-EU Regulatory Affairs and deputy head of the Regulatory Affairs department at Wörwag Pharma GmbH & Co. KG. Since 2017, Dr Kühnle has been working as an independent consultant specializing in global drug regulatory affairs, CMC, and interface issues between RA-QA and the pharmaceutical industry point of sale (pharmacies). He has also been the owner and manager of the Kirch Pharmacy in Hochdorf since 2017, and in 2020 and 2023 he took over the Eberhard Pharmacy in Notzingen and the Alb Pharmacy in Schlierbach as the new owner.

Director, Principal Consultant Regulatory Operations After completing his studies, K.H. Loebel worked at Heidelberg University for several years before joining a biotechnology start-up company in 2000. K.H. Loebel has been with PharmaLex GmbH in Mannheim since 2005. He initially headed the Regulatory Operations department and has been Director and Principal Consultant Regulatory Operations Industry/Agency Liaisons since 2015. His responsibilities include managing electronic submissions, planning projects, and providing strategic advice to pharmaceutical companies.
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Cornelia Hippchen was responsible for assessing the pharmaceutical quality of medicinal products at the Federal Institute for Drugs and Medical Devices until 2009 and worked as a consultant for the Federal Ministry of Health from 2013 to 2021. She has particular expertise in the European context, including extensive work for the EMA and the EDQM.

Wilhelm Schlumbohm studied pharmacy at the Free University of Berlin and earned his doctorate in biochemistry at the Technical University of Berlin. Dr Schlumbohm is a specialist pharmacist for drug information and public pharmacy (health) services. He worked at the Federal Health Office and its successor institutions, the BfArM and BVL, in the field of human and veterinary drug approval. Dr Schlumbohm worked for 20 years on the certification process for the European Pharmacopoeia (EDQM). He was a co-opted member for quality issues on the Committee for Medicinal Products for Veterinary Use (CVMP) at the European Medicines Agency (EMA), where he was a member of the Scientific Advisory Working Party (SAWP) and the ASMF Procedure Working Group.