CMC-EXPERTS - Key Persons

Job Titles:

• Am Alten Schloß 1
• Founder of HORN Pharmaceutical Consulting

If you have any questions, please use the above-mentioned contact information in order to enter into a dialog with the experts of HORN Pharmaceutical Consulting. Dr. Hiltrud Horn, the founder of HORN Pharmaceutical Consulting, has more than 32 years of experience in the pharmaceutical and biotechnology industry. She is regularly invited as speaker at conferences, workshops and seminars on the development and registration of new chemical entities and biotech products. Dr. Horn has successfully developed her activities in the field of International regulatory affairs Project management Drug product development Quality/Chemistry, Manufacturing and Controls (CMC) Quality Assurance (QA) Medical writing Good Manufacturing Practice (GMP) Good Clinical Practice (GCP) Good Laboratory Practice (GLP) Preparation and submission of dossiers for clinical trials and for marketing authorisation Post-marketing activities (changes and renewals) After her graduation as a pharmacist from the University of Tuebingen in Germany she completed her studies with a PhD in Human Biology at the University of Ulm. Furthermore she holds an ECPM-Diploma (Diploma in Pharmaceutical Medicine) from the Eucor University of Basel. She has an additional qualification as pharmaceutical expert for drug information (Fachapotheker für Arzneimittelinformation) and as pharmaceutical expert for pharmaceutical analytics (Fachapotheker für pharmazeutische Analytik). Prior to establishing HORN Pharmaceutical Consulting, Dr. Horn had been in various managerial positions in pharmaceutical industry at F. Hoffman-La Roche in Basel (Switzerland), BASF Pharma, Knoll AG (later Abbott) with responsibilities for the development and registration of new drugs in Europe and US. Her activities were in the field of international regulatory affairs, project management, quality control, quality assurance, preparation of dossiers (quality part and clinical part), dossier compilation and submission. Furthermore she worked as consultant for the biotech industry at Cap Gemini Ernst & Young Deutschland GmbH. At the end of 2002, Dr. Hiltrud Horn decided to start her own business and became an independent consultant. Dr. Horn professional affiliations are: Deutsche Gesellschaft für Regulatory Affairs (DGRA) Drug Information Association (DIA) Deutsche Gesellschaft für Pharmazeutische Medizin e.V (DGPharMed) Parenteral Drug Association (PDA)