University of Bonn, Faculty of Pharmacy (Germany) Education of Students in Pharmacy Research and supervision of Ph. D. projects

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1 Curriculum vitae PERSONAL INFORMATION Werner Knöss WORK EXPERIENCE May 2005 Present Head of Department Federal Institute for Drugs and Medical Devices (BfArM), Bonn (Germany) Head of Department "Complementary and Alternative Medicines and Traditional Medicinal Products" May 2000 May 2005 Senior Scientist Federal Institute for Drugs and Medical Devices (BfArM), Bonn (Germany) Assessment of quality of herbal medicinal products and homeopathic medicinal products November 2012 Present Appointment Professor University of Bonn, Faculty of Pharmacy (Germany) Education of Students in Pharmacy Research and supervision of Ph. D. projects April 1997 April 2000 Assistant Professor (C2) University of Bonn, Institute of Pharmaceutical Biology (Germany) Research (molecular biology of terpene synthases, monoclonal antibodies to isoprenoids) and education of students of pharmacy April 1991 March 1997 Post-Doctoral Scientist University of Bonn (Germany) Research (biosynthesis of isoprenoids, plant cell and tissue culture) and education of students of pharmacy EDUCATION AND TRAINING December 1986 December 1990 Ph. D. Institute of Pharmaceutical Biology, University of Bonn (Germany) Biosynthesis of phenols in marine Algae. October 1980 November 1986 Diploma Biology University of Bonn (Germany) Structure elucidation of polyphenols from marine Algae. ADDITIONAL INFORMATION Expertise - regulatory affairs of herbal medicinal products, traditional herbal medicinal products, homeopathic medicinal products, anthroposophic medicinal products - Concepts for evaluation of safety, quality and efficacy of herbal medicinal products and traditional medicinal products - regulation of traditional medicinal products from Ayurvedic Medicine and TCM - scientific expertise in pharmacognosy, current analytical techniques, "omics"-technologies and molecular methods for identification and characterisation of medicinal plants, herbal substances, herbal preparations and herbal medicinal products 10/12/15 European Union, Page 1 / 5

2 Publications European regulatory framework for herbal medicinal products Challenges for traditional medicines. European Journal of Integrative Medicine 2014, 689 Orland A, Knapp K, König GM, Ulrich-Merzenich G, Knoess W Combining Metabolomic Analysis and Microarray Gene Expression Analysis in the Characterization of the Medicinal Plant Chelidonii majus L. Phytomedicine 21, 2014, Du Y, Wolf I-K, Zhuang W, Bodemann S, and Knopf H Use of herbal medicinal products among children and adolescents in Germany. BMC Complementary and Alternative Medicine 2014, 14:218, doi: / Meier B,, Wenng A, Saller R Blick in die Zukunft pflanzlicher Arzneimittel Forschende Komplementärmedizin 21,2014, Stolte F, Tradition und traditionelle pflanzliche Arzneimittel Zeitschrift für Phytotherapie 35, 2014, Kelber O, Wegener T, Steinhoff B, Staiger C, Wiesner J,, Kraft K Assessment of genotoxicity of herbal medicinal products: Application of the bracketing and matrixing concept using the example of Valerianae radix (valerian root) Phytomedicine (published online, Chinou I,, Calapai I Regulation of Herbal medicinal products in the EU an up-to-date scientific review. Phytochemistry reviews (published online, DOI /s ) Pflanzliche Arzneimittel Monographien als Richtschnur. Pharmazeutische Zeitung 159, 2014, , Reh K, Bodemann S, Kirchner C, Stolte F, Wiesner J Rechtliche Rahmenbedingungen. Pharmakon 2, 2014, , Dingermann T Komplementäre Therapierichtungen Information ist das Ziel. Editorial (Gastherausgeber), Themenheft Abgrenzungsfragen. Pharmakon 2, 2014, 81. Buchholzer M-L, Werner C, Current concepts on integrative safety assessment of active substances of botanical, mineral or chemical origin in homeopathic medicinal products within the European regulatory framework. Regulatory Toxicology and Pharmacology 68 (2014) , Chinou I Regulation of Medicinal Plants for Public Health - European Community Monographs on Herbal Substances, Planta medica 78, 2012, 1-5., Reh K, Bodemann S Pflanzliche Arzneimittel in Deutschland - Tonika und Stärkungsmittel. Zeitschrift für Phytotherapie 32, 2011, , Dingermann T Abgrenzungsfragen Editorial (Gastherausgeber), Themenheft Abgrenzungsfragen. Pharmazie in unserer Zeit 40, 2011, 293. Pflanzliche Arzneimittel für Kinder und Jugendliche - die regulatorische Sicht. Zeitschrift für 10/12/15 European Union, Page 2 / 5

3 Phytotherapie 31, 2010, Kirchner C, Werner C, Wirksamkeit, Unbedenklichkeit und Qualität homöopathischer Arzneimittel. Regulatorische Rahmenbedingungen und behördliche Anforderungen. Arzneimittel & Recht 6, 2010, Wiesner J, Die Prüfung pflanzlicher Zubereitungen auf Genotoxizität. Anforderungen, pragmatische Ansätze, Diskussionen. Zeitschrift für Phytotherapie 31, 2010, , Koch J, Reh K Pflanzliche Arzneimittel - Bewertung der Risiken und der Unbedenklichkeit. Zeitschrift für Phytotherapie 30, 2009, , Alban S. Pflanzliche Arzneimittel für Kinder. Pharmazie in unserer Zeit, 38, 2009, Daniel C., Kersten T., Kehraus S., König G.M., Identifizierung und Charakterisierung von Arzneipflanzen mit Metabolic Fingerprinting. Zeitschrift für Phytotherapie, 29, 2008, Kersten T., Daniel C., König G.M., Das Potenzial PCR-basierter Markermethoden zur Identifizierung von Arzneipflanzen. Zeitschrift für Phytotherapie, 29, 2008, , Stolte F., Reh K. Europäische Gesetzgebung zu besonderen Therapierichtungen. Bundesgesundheitsblatt, 51, 2008, Kirchner C., Werner C., Regulatorische Einordnung von Mistelpräparaten. Scheer, Alban, Becker, Holzgrabe, Kemper, Kreis, Matthes, Schilcher (Hrsg.): Die Mistel in der Tumortherapie 2: Aktueller Stand der Forschung und klinische Anwendung. KVC Verlag, 2008, 3-13 Porträt einer Arzneipflanze: Marrubium vulgare (Weißer Andorn) Zeitschrift für Phytotherapie, 27, 2006, Sichere und wirksame Arzneimittel. e.balance magazin für Soziales. Online-Magazin der Bundesregierung, März 2006, Haaf M. Porträt einer Arzneipflanze: Ilex paraguariensis (Mate) Zeitschrift für Phytotherapie, 26, 2005, Brand K., Klein C., Zündorf I., Dingermann T., Generation and characterisation of monoclonal antibodies to oleanolic acid. Planta medica, 70, 2004, , Schnädelbach D., Reh K. Probleme der Qualitätsbeurteilung und rechtliche Aspekte bei pflanzlichen Arzneimittel. Bundesgesundheitsblatt, 46, 2003, Keller K.,, Schnädelbach D., Reh K. Phytopharmaka: Begriffsbestimmungen und Hintergründe Bundesgesundheitsblatt, , Keller K., Warum Phytopharmaka? (Editorial) Bundesgesundheitsblatt, 46, 2003, 1035, Barcellos Falkenberg M. 10/12/15 European Union, Page 3 / 5

4 Phytotherapie in Brasilien. Zeitschrift für Phytotherapie, 21, 2000, Marrubium vulgare (white horehound): In vitro culture and production of the diterpene marrubiin and other secondary metabolites. In: Biotechnology in Agriculture and Forestry, Vol Medicinal and Aromatic Plants XI (Bajaj, Y.P.S. ed.). Springer-Verlag, 1999, Terpenbiosynthese in Bakterien und Pflanzen - neue Perspektiven. (Review) Pharmazie in unserer Zeit, 28,1999, und Zapp J. Accumulation of furanic labdane diterpenes in Marrubium vulgare and Leonurus cardiaca. Planta Med., 64, 1998, und Reuter B. Biosynthesis of isoprenic units via different pathways: occurrence and future prospects. Pharmaceutica Acta Helv., 73, 1998, Mate-Tee: Herkunft, Inhaltsstoffe und Wirkungen. Topicos Cadernos Brasil-Alemanha, 36, 1997 (2), 14-17, Reuter B. und Zapp J. Biosynthesis of the labdane diterpene marrubiin in Marrubium vulgare via a non-mevalonate pathway. Biochem. J., 326, 1997, Reuter B.,, Hemmerlin A. und Bach T.J. Protein-independent interaction of divalent metal ions with geranylgeranyl diphosphate and other prenyl diphosphates. Pharm. Pharmacol. Lett., 7, 1997, und Reuter B. Biosynthesis of [14C]geranylgeranyldiphosphate by a prenyltransferasesystem from a mutant strain of Gibberella fujikuroi. Anal. Biochem., 239, 1996, Establishment of callus, cell suspension and shoot cultures of Leonurus cardiaca and diterpene analysis. Plant Cell Rep., 14, 1995, Furanic labdane diterpenes in differentiated and undifferentiated cultures of Marrubium vulgare and Leonurus cardiaca. Plant Physiol. Biochem., 32, 1994, und Glombitza K.-W. A phenolsulphatase from the marine Brown alga Cystoseira tamariscifolia. Phytochemistry, 32, 1993, Glombitza K.-W. und Sulphated phlorotannins from the Brown alga Pleurophycus gardneri. Phytochemistry, 31, 1992, Glombitza K.-W.,, Deutscher B., Haas L., Piepenbrink G., Li S.-M. und Peter Katalinic J. Phenol sulphate esters from Phaeophyceae. OEBALIA, International Journal of Marine Biology and Oceanography, 17, 1991, /12/15 European Union, Page 4 / 5

5 Phenolsulphatase und Phloroglucinbiosynthese in der marinen Braunalge Cystoseira tamariscifolia. Dissertation, Universität Bonn, 1990 Peter-Katalinic J., Egge H., Deutscher B., und Glombitza K.-W. A rapid method for the structural characterization of sulphated phlorotannins by negative ion FAB-mass spectrometry and acetylation on the target. Biomed. Environm. Mass spectrometry, 15, 1988, Projects Current research topics, supervision of research projects (Ph. D.): - Potential of "omics"-technologies and PCR-related methods to identify and characterize medicinal plants, herbal substances and herbal preparations (PCR, microarray-analysis, analytical fingerprinttechniques, Principal Component Analysis) - Consortium member GP-TCM (EU-project 7th framework, ) For further projects see recent publications Memberships - German delegate to the HMPC (EMA, London) from 2006 to Chairperson of the HMPC since Vice-chairperson of the MLWP (EMA, London) from 2009 to German Delegate to the HMPWG (HMA) since Chairperson of the HMPWG in Member of the Steering Committee for Certificates of Suitability (EDQM, Strasbourg) since Member of the Scientific Coordination Board (EMA, London) since Chair of the German Homeopathic Pharmacopeia Commission since Member of the Scientific Council of BfArM from 2004 to Member of the Editorial Board of the journal Phytochemistry Letters since Member of the Editorial Board of the journal Phytomedicine since Member of the Scientific Curatorium of the German Society of Phytotherapy since Member of the Board of the subgroup Pharmaceutical Biology of the German Pharmaceutical Society from 2007 to 2013 Other Relevant Information - Appointment extraordinary "Professor" to the University of Bonn, Germany, Faculty of Pharmacy, Institute of Pharmaceutical Biology in Appointment "Visiting Professor" to the School of Pharmacy, Center of Pharmacognosy, University College London in Lecturer at the University of Innsbruck, Austria, Institute of Pharmacognosy in 2013 and Habilitation and Venia legendi "Pharmaceutical Biology" and appointment "Privatdozent" at the University of Bonn in Research Coordinator of the Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany from 2004 to Research stay at CNRS, University of Strasbourg, France in spring Short-term guest-lectureship at the University of Florianopolis (Brazil) in 2001 and 2002 (awarded by the German Federal Academic Exchange Service, DAAD) 10/12/15 European Union, Page 5 / 5