Werner Knöss - European Medicines Agency

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
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Curriculum vitae
Publications
Werner Knöss
Knöss W, Reh K
Gesetzliche Grundlagen – Anforderungen an pflanzliche Arzneimittel.
[Legal framework – requirements on herbal medicinal products].
Pharmakon, 2016, 4(4):332-335 [German]
Bodemann S, Du Y, Wolf IK, Zhuang W, Knopf H, Knöss W
Anwendung pflanzlicher Arzneimittel bei Kindern und Jugendlichen in Deutschland. Zeitschrift für
Phytotherapie, 2015, 36:250-255
Knöss W, Chinou I
Traditional herbal medicines in the European Union: Implementing standardization and regulation. In:
The Art and Science of Traditional Medicine Part 3: The Global Impact of Traditional Medicine.
Science, 2015, 350(6282):871, S59-S60; DOI: 10.1126/science.350.6282.871-c
Knöss W
Contributions and visions of the Committee on Herbal Medicinal Products (HMPC). 63rd International
Congress and Annual Meeting of the Society for Medicinal Plant and Natural Product Research (GA
2015), 2015, Budapest, Hungary
Plant Med 2015:81-RAW_01; DOI: 10.1055/s-0035-1565373
Knöss W
Harmonization of regulatory requirements in Europe to ensure quality, safety and efficacy of herbal
medicinal products. In: Mukherjee PK (ed.). Evidence-Based Validation of Herbal Medicine. 2015,
Elsevier, 201-216
Knöss W
Harmonisierung in der Pflanzenheilkunde: Europäische Standards für pflanzliche Arzneimittel.
Österreichische Apotheker-Zeitung, 2015, 69(6):25-27
Knöss W
Regulation of Herbal Medicines. Editorial (Gastherausgeber),
Journal of Ethnopharmacology, 2014, 158(Part B):448
Wiesner J, Knöss W
Future visions for traditional and herbal medicinal Products – A global practice for evaluation and
regulation?.
Journal of Ethnopharmacology, 2014, 158(Part B):516-518
Knöss W
European regulatory framework for herbal medicinal products – Challenges for traditional medicines.
European Journal of Integrative Medicine, 2014, 689
Orland A, Knapp K, Ulrich-Merzenich G, König GM, Knöss W
Differential transcriptional profiles in HepG2 cells after the exposure to a chemically characterized
complex preparation of Silybi mariani fructus and its chemically defined constituent silybin A + B,
Synergy 1, 2014, 99-108
Knöss W
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, 1587-1596
Du Y, Wolf I-K, Zhuang W, Bodemann S, Knöss W and Knopf H
Use of herbal medicinal products among children and adolescents in Germany.
BMC Complementary and Alternative Medicine 2014, 14:218, doi:10.1186/1472-6882-14-218
Meier B, Knöss W, Wenng A, Saller R
Blick in die Zukunft pflanzlicher Arzneimittel
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Curriculum vitae
Werner Knöss
Forschende Komplementärmedizin 21,2014, 28-33
Stolte F, Knöss W
„Tradition“ und traditionelle pflanzliche Arzneimittel
Zeitschrift für Phytotherapie 35, 2014, 63-67
Kelber O, Wegener T, Steinhoff B, Staiger C, Wiesner J, Knöss W, 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, http://dx.doi.org/10.101016/j.phymed.2014.04.003)
Chinou I, Knöss W, Calapai I
Regulation of Herbal medicinal products in the EU – an up-to-date scientific review.
Phytochemistry reviews (published online, DOI 10.1007/s11101-014-9354-4)
Knöss W
Pflanzliche Arzneimittel – Monographien als Richtschnur.
Pharmazeutische Zeitung 159, 2014, 42-47.
Knöss W, Reh K, Bodemann S, Kirchner C, Stolte F, Wiesner J
Rechtliche Rahmenbedingungen.
Pharmakon 2, 2014, 143-150.
Knöss W, Dingermann T
Komplementäre Therapierichtungen – Information ist das Ziel. Editorial (Gastherausgeber),
Themenheft Abgrenzungsfragen. Pharmakon 2, 2014, 81.
Buchholzer M-L, Werner C, Knöss W
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) 193–200.
Knöss W, Chinou I
Regulation of Medicinal Plants for Public Health - European Community Monographs on Herbal
Substances, Planta medica 78, 2012, 1-5.
Knöss W, Reh K, Bodemann S
Pflanzliche Arzneimittel in Deutschland - Tonika und Stärkungsmittel. Zeitschrift für Phytotherapie 32,
2011, 164-166.
Knöss W, Dingermann T
Abgrenzungsfragen – Editorial (Gastherausgeber), Themenheft Abgrenzungsfragen. Pharmazie in
unserer Zeit 40, 2011, 293.
Knöss W
Pflanzliche Arzneimittel für Kinder und Jugendliche - die regulatorische Sicht. Zeitschrift für
Phytotherapie 31, 2010, 13-16.
Kirchner C, Werner C, Knöss W
Wirksamkeit, Unbedenklichkeit und Qualität homöopathischer Arzneimittel. Regulatorische
Rahmenbedingungen und behördliche Anforderungen. Arzneimittel & Recht 6, 2010, 108-115.
Wiesner J, Knöss W
Die Prüfung pflanzlicher Zubereitungen auf Genotoxizität. Anforderungen, pragmatische Ansätze,
Diskussionen. Zeitschrift für Phytotherapie 31, 2010, 127-133.
Knöss W, Koch J, Reh K
Pflanzliche Arzneimittel - Bewertung der Risiken und der Unbedenklichkeit. Zeitschrift für
Phytotherapie 30, 2009, 29-32.
Knöss W., Alban S.
Pflanzliche Arzneimittel für Kinder.
Pharmazie in unserer Zeit, 38, 2009, 50-53
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Curriculum vitae
Werner Knöss
Daniel C., Kersten T., Kehraus S., König G.M., Knöss W.
Identifizierung und Charakterisierung von Arzneipflanzen mit „Metabolic Fingerprinting“.
Zeitschrift für Phytotherapie, 29, 2008, 270-274
Kersten T., Daniel C., König G.M., Knöss W.
Das Potenzial PCR-basierter Markermethoden zur Identifizierung von Arzneipflanzen.
Zeitschrift für Phytotherapie, 29, 2008, 122-128
Knöss W., Stolte F., Reh K.
Europäische Gesetzgebung zu besonderen Therapierichtungen.
Bundesgesundheitsblatt, 51, 2008, 771-778
Kirchner C., Werner C., Knöss W.
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
Knöss W.
Porträt einer Arzneipflanze: Marrubium vulgare (Weißer Andorn)
Zeitschrift für Phytotherapie, 27, 2006, 255-258
Knöss W.
Sichere und wirksame Arzneimittel.
e.balance – magazin für Soziales. Online-Magazin der Bundesregierung, März 2006
Knöss W., Haaf M.
Porträt einer Arzneipflanze: Ilex paraguariensis (Mate)
Zeitschrift für Phytotherapie, 26, 2005, 94-98
Brand K., Klein C., Zündorf I., Dingermann T., Knöss W.
Generation and characterisation of monoclonal antibodies to oleanolic acid.
Planta medica, 70, 2004, 986-992
Knöss W., Schnädelbach D., Reh K.
Probleme der Qualitätsbeurteilung und rechtliche Aspekte bei pflanzlichen Arzneimittel.
Bundesgesundheitsblatt, 46, 2003, 1040-1045
Keller K., Knöss W., Schnädelbach D., Reh K.
Phytopharmaka: Begriffsbestimmungen und Hintergründe
Bundesgesundheitsblatt, 46 2003, 1036-1039
Keller K., Knöss W.
Warum Phytopharmaka? (Editorial)
Bundesgesundheitsblatt, 46, 2003, 1035
Knöss W., Barcellos Falkenberg M.
Phytotherapie in Brasilien.
Zeitschrift für Phytotherapie, 21, 2000, 328-338
Knöss W.
Marrubium vulgare (white horehound): In vitro culture and production of the diterpene marrubiin and
other secondary metabolites. In: Biotechnology in Agriculture and Forestry, Vol. 43 - Medicinal and
Aromatic Plants XI (Bajaj, Y.P.S. ed.). Springer-Verlag, 1999, 274-289
Knöss W.
Terpenbiosynthese in Bakterien und Pflanzen - neue Perspektiven. (Review)
Pharmazie in unserer Zeit, 28,1999, 247-254
Knöss W. und Zapp J.
Accumulation of furanic labdane diterpenes in Marrubium vulgare and Leonurus cardiaca.
Planta Med., 64, 1998, 357-361
Knöss W. und Reuter B.
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Curriculum vitae
Werner Knöss
Biosynthesis of isoprenic units via different pathways: occurrence and future prospects.
Pharmaceutica Acta Helv., 73, 1998, 45-52
Knöss W.
Mate-Tee: Herkunft, Inhaltsstoffe und Wirkungen.
Topicos Cadernos Brasil-Alemanha, 36, 1997 (2), 14-17
Knöss W., Reuter B. und Zapp J.
Biosynthesis of the labdane diterpene marrubiin in Marrubium vulgare via a non-mevalonate pathway.
Biochem. J., 326, 1997, 449-454
Reuter B., Knöss W., 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, 141-144
Knöss W. und Reuter B.
Biosynthesis of [14C]geranylgeranyldiphosphate by a prenyltransferasesystem
from a mutant strain of Gibberella fujikuroi.
Anal. Biochem., 239, 1996, 208-212
Knöss W.
Establishment of callus, cell suspension and shoot cultures of
Leonurus cardiaca and diterpene analysis.
Plant Cell Rep., 14, 1995, 790-793
Knöss W.
Furanic labdane diterpenes in differentiated and undifferentiated cultures
of Marrubium vulgare and Leonurus cardiaca.
Plant Physiol. Biochem., 32, 1994, 585-589
Knöss W. und Glombitza K.-W.
A phenolsulphatase from the marine Brown alga Cystoseira tamariscifolia.
Phytochemistry, 32, 1993, 1119-1123
Glombitza K.-W. und Knöss W.
Sulphated phlorotannins from the Brown alga Pleurophycus gardneri.
Phytochemistry, 31, 1992, 279-281
Glombitza K.-W., Knöss 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, 381-385
Knöss W.
Phenolsulphatase und Phloroglucinbiosynthese in der marinen Braunalge Cystoseira tamariscifolia.
Dissertation, Universität Bonn, 1990
Peter-Katalinic J., Egge H., Deutscher B., Knöss W. 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, 595-602
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, 2009-2012)
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Curriculum vitae
Werner Knöss
For further projects see recent publications
Memberships
- German delegate to the HMPC (EMA, London) from 2006 to 2010
- Chairperson of the HMPC from 2010 to 2016
- Vice-chairperson of the MLWP (EMA, London) from 2009 to 2011
- Member of the MLWP since 2007
- German Delegate to the HMPWG (HMA) since 2007
- Chairperson of the HMPWG in 2007
- Member of the Steering Committee for Certificates of Suitability (EDQM, Strasbourg) from 2010 to
2016
- Member of the Scientific Coordination Board (EMA, London) from 2012 to 2016
- Chair of the German Homeopathic Pharmacopeia Commission since 2013
- Member of the Scientific Council of BfArM from 2004 to 2012
- Member of the Editorial Board of the journal Phytochemistry Letters since 2009
- Member of the Editorial Board of the journal Phytomedicine since 2015
- Member of the Scientific Curatorium of the German Society of Phytotherapy since 2011
- 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 2012
- Appointment "Visiting Professor" to the School of Pharmacy, Center of Pharmacognosy, University
College London in 2005
- Lecturer at the University of Innsbruck, Austria, Institute of Pharmacognosy in 2013, 2015 and 2016
- Habilitation and Venia legendi "Pharmaceutical Biology" and appointment "Privatdozent" at the
University of Bonn in 1997
- Research Coordinator of the Federal Institute for Drugs and Medical Devices (BfArM), Bonn,
Germany from 2004 to 2012
- Research stay at CNRS, University of Strasbourg, France in spring 1996
- Short-term guest-lectureship at the University of Florianopolis (Brazil) in 2001 and 2002 (awarded by
the German Federal Academic Exchange Service, DAAD)
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