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Biblio LCC 2015

Louis-Christian Clauss
Louis-Christian Clauss

This document contains a bibliography listing 57 publications authored by L.C. Clauss spanning from 1978 to 2006. The publications cover a wide range of topics related to medical devices, regulations, biocompatibility testing, and reimbursement. Many were presented at international conferences on topics such as biomaterials, medical device regulations in Europe and the US, clinical trials, and health technology assessment.

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Biblio 09 27 2011 1 BIBLIOGRAPHY 1. L.C. CLAUSS Aspects particuliers de certaines immunoglobulines chez le lapin. Journ辿e dEtude CNRS, 26-27 mai 1978, Orl辿ans 2. B. GUERIN, LC. CLAUSS, P. JACQUET and D. MARZIN Contr担le et standardisation des R辿actig竪nes pour 辿pidermo-r辿action. XVIII竪 Symposium des Centres Anti-poison, Paris, 20/21 Septembre 1979. 3. L.C. CLAUSS, D. MARZIN and J.L. ROUAUD Implication Biologique de la L辿gislation sur le Contr担le des Produits Chimiques. Info-Chimie, 189, 151-155, 1979 4. J. BOUSQUET, J.P. MARTY, L.C. CLAUSS and F.B. MICHEL Bee Venon Enzymes 35th A.C., 42, 125, 1979 5. L.C. CLAUSS Suppression de la r辿ponse r辿aginique par des conjugu辿s tol辿rog竪nes. Dipl担me dEtudes Approfondies de Biopharmacie et de recherche gal辿nique Paris XI, 19.10.1979 6. J.P. DONNE, L.C. CLAUSS, B. GUERIN and J. BIGNON Comparaison des r辿actions cliniques avec les r辿sultats des tests biologiques : 束 R.A.S.T. et test de d辿granulation des basophiles humains dans 54 observations dallergies respiratoires la poussi竪re de maison 損. Nouv. Press. Med., 9, 3335-3337, 1980 7. B. GUERIN, L.C. CLAUSS and M. ROUMIANTZEFF Un mod竪le dEtude Immunopharmacologique des Vaccins et Allerg竪nes Bact辿riens (exemple dapplication aux m辿langes polymicrobiens). Med. Et Hyg., 38, 2736-2745, 1980 8. D. MARZIN, B. GUERIN and L.C. CLAUSS How to use auto-immune-encephalomyelitis (A.I.E.) in rats as a screening test for immuno-depressants and immuno-modulators. Institut Merieux Report 1980 9. JA. COLQUHOUN, L.C. CLAUSS and D. POCKNELL Silicone Elastomer FoamDressing European Society of Biomaterials Conference Durham 12-14 Juillet 1981.
Biblio 09 27 2011 2 10. L.C. CLAUSS Medical Grade Silicone Fluid ; Background of Controversy. 31 Congresso Nationale della Societa Italiana di Chirurgica Plastica. Pavia, 22/25 Septembre 1982 11. L.C. CLAUSS Generalita Sul Dimetilpolisilossano Min. Chir., 38, 863-865, 1983 12. L.C. CLAUSS Exemples de Pansements Polym辿riques Syst竪me Matriciels Polym辿riques Biocompatibles. AGPI Pr DUCHENE, Pr VERAIN, Pr ALEXANDRE 11/12, 1986 13. L.C. CLAUSS Caract辿ristiques Techniques et developpement des Proth竪ses dExpansion Tissulaire. 1er Symposium Fran巽ais sur lexpansion tissulaire. Lyon (France) Pr BAUX and Dr MASSON, 20.09.86 14. L.C. CLAUSS, W.B. PFISTER, R.P. SWEET and P.A. WALTERS Les Elastom竪res de Silicone M辿dicale, Biocompatibilit辿 ; Interaction avec diff辿rents principes actifs et modulation de leur perm辿abilit辿. 4th International Conference on pharmaceutical Technology Paris, 3/5.06.1986 15. M. RODY and L.C. CLAUSS Testing of Silicone Dressings using an in-vitro cell culture method. European Congress on Biomaterials, bologna, 14-17.09.1986 16. L.C. CLAUSS, M. PITRE and F. BOURILLET Wich Way Now in France (medical devices regulation) Clinica, 242, 10-11, 1987 17. L.C. CLAUSS Examples de Pansements Polym辿riques S.T.P. Pharma, 4, 313-318, 1987 18. L.C. CLAUSS and E. BAFFERT Biomat辿riaux et Biocompatibilit辿 : Les silicones m辿dicales Lyon Pharmaceutique, 38, 101-109, 1987 19. L.C. CLAUSS Les d辿riv辿s Organiques du Silicium en S辿nologie : 25 ans d辿j. Journ辿e de Chirurgie Esth辿tique de lH担pital Am辿ricain de Neuilly, Dr GLICENSTEIN & Pr. I. PITANGUY June 18th 1987
Biblio 09 27 2011 3 20. L.C. CLAUSS An overview of French Device Regulations in Relation to the Rest of Europe. Regulation of Medical Devices and Surgical Products in Europe EUCOMED, Brussels, 9/10.03.87 21. L.C. CLAUSS Regulatory aspects and Pharmacopeial Compliance of Polymeric Materials. Scientific Program, DC Pharma Lab opening Conference 02.09.1987 22. L.C. CLAUSS Co Chairman with Pr Williams and M. Reinikainen of the R.A.P.S. International Conference on Biosafety and Biocompatibility of Medical Devices. Nice (France) 14-15 Juillet 1988 23. L.C. CLAUSS Comparaison des diff辿rents syst竪mes dhomologation de mat辿riel m辿dico-chirurgical, l辿tude dans la CEE - Perspectives davenir. 4竪 rencontre Conditionnement et Sant辿 Pr辿sidence Pr. Pellerin et Pr. Marty Paris (France) 14 juin 1988 24. M. ROSDY, L.C. CLAUSS Cytotoxicity testing of wound dressings using normal human keratinocytes in culture JOURNAL OF BIOMEDICAL MATERIAL RESEARCH, vol 24, N属3, March 1990 25. M. ROSDY, L.C. CLAUSS Evaluation of cytocompatibility and growth promotion of drug releasing silicone wound dressings using cultures of normal human keratinocytes in defined medium BIOMAT Bordeaux (France) 17, 18, 19 Octobre 1988 26. L.C. CLAUSS French regulations of medical devices and surgical products. IBC New orleans (USA) 14 et 15 novembre 1988 27. L.C. CLAUSS Biosafety and Biocompatibility of Medical Devices : New Approach Workshop on the European Standardization of Medical Devices. CEN/CENELEC Brussels 12, 13, 14 D辿cembre 1988
Biblio 09 27 2011 4 28. L.C. CLAUSS, V. DE ALMEIDA 束 French Regulations of Medical Devices and Surgical Products 損. 1988-1992 - Medical devices labelling harmonisation. EUCOMED. Frankfurt - 16, 17 f辿vrier 1989 29. L.C. CLAUSS, V. DE ALMEIDA Economic considerations in the control of ethylene oxide sterilisation. Ethylene oxide sterilisation. EUCOMED Paris 20, 21 avril 1989 30. L.C. CLAUSS Chairman of the R.A.P.S. International conference on the 束 Clinical trials with drugs and devices: A rational approach 損. Nice 18, 19 mai 1989 31. M. ROSDY and L.C. CLAUSS Terminal Epidermal differentiation of human keratinocytes grown in Chemically defined Medium on inert filter substrates at the Air- Liquid Interface. The Journal of Investigative Dermatology 95 : 409-414 ; 1990 32. M. ROSDY and L.C. CLAUSS Evaluation of cytocompatibility and growth promotion of drug releasing silicone wound dressings using cultures of normal human keratinocytes in defined medium. Organes artificiels hybrides C. Baquey B. Dupuy Eds. INSERM Vol 177, 171-180 (1989) 33. L.C. CLAUSS and J.D. NURY Essais Cliniques ou Evaluation Clinique du Mat辿riel m辿dico- chirurgical lH担pital ? Perspectives internationales du point de vue de lindustriel. ORPHEM, 束 Essais Cliniques des M辿dicaments, Mat辿riel M辿dico- chirurgical : Normes - R辿glementations 損. 30, 31 Mars 1990 34. L.C. CLAUSS New Application of Silicone in the field of Drug Delivery System. C.H.I. FRANKFURT 8-9 October 1990 35. L.C. CLAUSS Aspects R辿glementaires du d辿veloppement de dispositifs M辿dico- chirurgicaux pr辿par辿s au moyen de Biomat辿riaux. USA, JAPON, EUROPE SYNBIO LYON 17-19 Octobre 1990
Biblio 09 27 2011 5 36. L.C. CLAUSS International regulatory controls and standards, U.S.A., JAPON, EUROPE BIOCERAMICS and the HUMAN BODY FAENZA Avril 2-5th 1991 37. M. ROSDY, B. GRISONI and L.C. CLAUSS Proliferation of normal human keratinocytes on silicone substrate BIOMATERIALLS, 12 511-517 ; 1991 38. L.C. CLAUSS (chairman) Biological evaluation of medical and dental materials and devices: Selection of tests Workshop, Strategy of testing. VI WORLD CONGRESS ON BIOMATERIALS BERLIN APRIL 25-27th , 1992 39. L.C. CLAUSS Biological evaluation of medical and dental materials and devices : Selection of tests. PRINCIPLE OF BIOCOMPATIBILITY RAPS INTERNATIONAL PARIS OCTOBER 7-9th , 1992 40. L.C. CLAUSS Reimbursement and pricing for medical devices in Europe. I.B.C. February 16th 1998 41. L.C. CLAUSS Integration of economical studies for reimbursement in the course of clinical trials. RAPS INTERNATIONAL LONDON February 1998 V ANNUAL CONVENTION 42. L.C. CLAUSS Funding and Reimbursement issues in Europe Symposium on Reimbursement and pricing for medical devices in Europe. I.B.C. Brussels February 25th 2000 43.L.C. CLAUSS Funding and Reimbursement in Europe, Industry point of view regarding Health Care Technology Assessment. RAPS INTERNATIONAL VIENNA, VI ANNUAL CONVENTION May 9th , 2000
Biblio 09 27 2011 6 44.L.C. CLAUSS Health Care Technology Assessment in Europe. A Medical devices Industry perspective. ISTHAC 16th International Conference den Hague June 18th , 2000 45. L.C. CLAUSS Remboursement et Prise en charge des dispositifs M辿dico- Chirurgicaux en Europe. Point de vue de lIndustrie Europ辿enne Euroforum Paris June 20th, 2 000 46. L.C. CLAUSS What is Health Care Technology Assessment ? Why should the Medical Devices Industry be concerned ? Health Technology Assessment for Medical Devices Symposium I.B.C. London July 03rd, , 2000 47 L.C. CLAUSS Funding and Reimbursement of Borderline & Drug Delivery systems in Europe. Symposium on European Reimbursement Medical devices Management Forum . London September 14&15th , 2000 48. L.C. CLAUSS Comment int辿grer les donn辿es 辿conomiques dans le cadre des essais cliniques pour l辿valuation du services m辿dicale rendu. Euroforum, Paris November 21, 2000 49. L.C. CLAUSS Comment int辿grer les donn辿es 辿conomiques dans le cadre des essais cliniques pour l辿valuation du service m辿dical rendu. Euroforum, Paris March 20, 2001 50. L.C. CLAUSS Strat辿gie de prise en charge et de remboursement des dispositifs m辿dicaux. Euroforum, Paris March 21, 2001 51. L.C. CLAUSS Health Care Technology Assessment, Industry Point of view. IBC Brussel, April 3, 2001 52. M.Siebert, L.C.Clauss, M.Carlisle, B.Casteels, P.de.Jong, M.Kreuzer, S.Sanghera, G.Stokoe, P.Trueman, A.Wenk-Lang Health Care Technology Assessment, EUCOMED Position Paper. INTL.J.TECHNOLOGY ASSESSMENT IN HEALTH CARE 18:3, 2002 53.L.C. CLAUSS ISO 14 971 Implementation of Risk Management for Medical Devices. P.D.A Paris, December 7th, 2004
Biblio 09 27 2011 7 54.L.C. CLAUSS Chairman of the Session regarding Current process for Follow-on proteins in Europe: The BioSimilars products (362). 41 st Annual global meeting DIA, Washington, June 26-30 2005 Biotech track 55.L.C. CLAUSS BIOSIMILAR; A balanced approach: View of a Product Developer. 42 st Annual global meeting DIA, Philadelphia, June 18-22 2006 Biotech track 56.L.C. CLAUSS A Biotech developers point of view of the future of BioSimilar and FOBs: Will it be the next revolution? BioSimilars, Bringing follow-on biologics to market, IBC Zurich, June 29-30 2006. 57.L.C. CLAUSS BioSimilar in Europe Highway or dead end? RAPS Annual Global Conference, Baltimore, October 15-18 2006. Chairman of the session about BioSimilar 58 L.C.CLAUSS Future developments for the BioSimilar drug Industry in the US and EU: A Biotech developers perspective. Biogenerics 2007 Visiongain Symposium. London May 22-24 2007 59 L.C.CLAUSS Marketing and globalising Biosimilar in a competitive landscape BioLogic Europe 2007 Lifescienceworld Symposium. Geneva June 11-14 2007 60 L.C.CLAUSS Optimising Clinical program for registration in the European Union. 43 Annual meeting DIA Atlanta June 18 21 2007 Regulatory Affairs Track 61 L.C.CLAUSS A Biotech Developers point of view of the future of BioSimilar. 2nd BioPharm Asia, Singapore , IBC Sept 26-27 2007 62 L.C.CLAUSS Examining opportunities and challenges for BioSimilars in Europe. 3rd BioSimilars conference Visiongain London December 5-7 2007 63 L.C.CLAUSS Proof of Concept and level of evidence in Orphan Drug development A Biotech Developers point of view. 7th ERTC Workshop Eurordis Paris December 14 2007
Biblio 09 27 2011 8 64. L.C.CLAUSS BioSimilars: dead end or highway to success? A personal perspective. BioSimilars 2008 , VIB Brussels February 19&20 2008 65. L.C.CLAUSS Technical Assessment and due diligence for Phamaceutical and Biotech deal. Phrmaceutical Collaboration 2008, London February 20&21st 2008 66. L.C.CLAUSS Technical Assessment and due diligence for Biotech with a specifial attention to BioSimilars Phrmaceutical Collaboration 2008, Dublin June 26&27st 2008 67. L.C.CLAUSS BioSimilars: dead end or highway to success? A personal perspective. BioSimilars 2008 , Vth Annual Informa Berlin September 10&11 2008 68. L.C.CLAUSS Chairman. BioLogic Europe 2008, Terrapin Life Science World Geneva September 16-18 2008 69. L.C.CLAUSS Specialized BioTech Companies, Opportunities, Challenges and risks. BioLogic Europe 2008, Terrapin Life Science World Geneva September 16-18 2008 70. L.C.CLAUSS Working with the FDA / EMEA Walking the Maze. BioLogic Europe 2008, Terrapin Life Science World Geneva September 16-18 2008 71. L.C.CLAUSS Using evolving regulatory pathways for drug-devices combination Phacilitate, R&D and Oncology Leaders forum San Diego October 28-30 2008 73. L.C.CLAUSS Optimising the clinical program for registration in the European Union Clinical Trial Logistic SMI London May 20-21 200972. 74. L.C.CLAUSS How huge is the threat from BioSimilar for Originators ? Phacilitate, R&D and Oncology Leaders forum San Diego October 28-30 2008
Biblio 09 27 2011 9 75. L.C.CLAUSS Clinical Trial Registration Optimising the clinical program for registration in the European Union Conducting Clinical Trial in Europe, SMI London October 12 & 13 2009. 76. L.C.CLAUSS BioSimilars: Regulatory expectation on a global basis Is it possible to set up a global project? BioSimilars 2009 , VIth Annual Informa Berlin September November 18&19 2009 77. L.C.CLAUSS BioSimilars: Chairman BioSimilars 2009 , VIth Annual, Informa Berlin November 18th 2009 78. L.C.CLAUSS Workshop:How to construct and navigate a BioSimilar Highway to global success by overcoming Regulatory and development hurdles BioSimilars 2009 , VIth Annual, Informa Berlin November 20th 2009 79.L.C.CLAUSS Regulatory expectation on a Global bsis for Biosimilars BioSimilars 2010 , VIIth Annual, Informa , Koln June 8th 2010 80. L.C.CLAUSS Strategy for Entering the BioSimilars global Markets Highway or Dead end ?? Examining opportunities and challenges for Biosimilars in Global Markets Characterization & comparability for Biologics April 4-7th 2011 C.H.I Bethesda USA 81. L.C.CLAUSS Industry interpr辿tation of the new guideline on Biosimilars Mono- clonal Antibodies Biosimilars and Biobetters, September 26th & 27th 2011, S.M.I London, U.K
Biblio 09 27 2011 10

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Biblio LCC 2015

  • 1. Biblio 09 27 2011 1 BIBLIOGRAPHY 1. L.C. CLAUSS Aspects particuliers de certaines immunoglobulines chez le lapin. Journ辿e dEtude CNRS, 26-27 mai 1978, Orl辿ans 2. B. GUERIN, LC. CLAUSS, P. JACQUET and D. MARZIN Contr担le et standardisation des R辿actig竪nes pour 辿pidermo-r辿action. XVIII竪 Symposium des Centres Anti-poison, Paris, 20/21 Septembre 1979. 3. L.C. CLAUSS, D. MARZIN and J.L. ROUAUD Implication Biologique de la L辿gislation sur le Contr担le des Produits Chimiques. Info-Chimie, 189, 151-155, 1979 4. J. BOUSQUET, J.P. MARTY, L.C. CLAUSS and F.B. MICHEL Bee Venon Enzymes 35th A.C., 42, 125, 1979 5. L.C. CLAUSS Suppression de la r辿ponse r辿aginique par des conjugu辿s tol辿rog竪nes. Dipl担me dEtudes Approfondies de Biopharmacie et de recherche gal辿nique Paris XI, 19.10.1979 6. J.P. DONNE, L.C. CLAUSS, B. GUERIN and J. BIGNON Comparaison des r辿actions cliniques avec les r辿sultats des tests biologiques : 束 R.A.S.T. et test de d辿granulation des basophiles humains dans 54 observations dallergies respiratoires la poussi竪re de maison 損. Nouv. Press. Med., 9, 3335-3337, 1980 7. B. GUERIN, L.C. CLAUSS and M. ROUMIANTZEFF Un mod竪le dEtude Immunopharmacologique des Vaccins et Allerg竪nes Bact辿riens (exemple dapplication aux m辿langes polymicrobiens). Med. Et Hyg., 38, 2736-2745, 1980 8. D. MARZIN, B. GUERIN and L.C. CLAUSS How to use auto-immune-encephalomyelitis (A.I.E.) in rats as a screening test for immuno-depressants and immuno-modulators. Institut Merieux Report 1980 9. JA. COLQUHOUN, L.C. CLAUSS and D. POCKNELL Silicone Elastomer FoamDressing European Society of Biomaterials Conference Durham 12-14 Juillet 1981.
  • 2. Biblio 09 27 2011 2 10. L.C. CLAUSS Medical Grade Silicone Fluid ; Background of Controversy. 31 Congresso Nationale della Societa Italiana di Chirurgica Plastica. Pavia, 22/25 Septembre 1982 11. L.C. CLAUSS Generalita Sul Dimetilpolisilossano Min. Chir., 38, 863-865, 1983 12. L.C. CLAUSS Exemples de Pansements Polym辿riques Syst竪me Matriciels Polym辿riques Biocompatibles. AGPI Pr DUCHENE, Pr VERAIN, Pr ALEXANDRE 11/12, 1986 13. L.C. CLAUSS Caract辿ristiques Techniques et developpement des Proth竪ses dExpansion Tissulaire. 1er Symposium Fran巽ais sur lexpansion tissulaire. Lyon (France) Pr BAUX and Dr MASSON, 20.09.86 14. L.C. CLAUSS, W.B. PFISTER, R.P. SWEET and P.A. WALTERS Les Elastom竪res de Silicone M辿dicale, Biocompatibilit辿 ; Interaction avec diff辿rents principes actifs et modulation de leur perm辿abilit辿. 4th International Conference on pharmaceutical Technology Paris, 3/5.06.1986 15. M. RODY and L.C. CLAUSS Testing of Silicone Dressings using an in-vitro cell culture method. European Congress on Biomaterials, bologna, 14-17.09.1986 16. L.C. CLAUSS, M. PITRE and F. BOURILLET Wich Way Now in France (medical devices regulation) Clinica, 242, 10-11, 1987 17. L.C. CLAUSS Examples de Pansements Polym辿riques S.T.P. Pharma, 4, 313-318, 1987 18. L.C. CLAUSS and E. BAFFERT Biomat辿riaux et Biocompatibilit辿 : Les silicones m辿dicales Lyon Pharmaceutique, 38, 101-109, 1987 19. L.C. CLAUSS Les d辿riv辿s Organiques du Silicium en S辿nologie : 25 ans d辿j. Journ辿e de Chirurgie Esth辿tique de lH担pital Am辿ricain de Neuilly, Dr GLICENSTEIN & Pr. I. PITANGUY June 18th 1987
  • 3. Biblio 09 27 2011 3 20. L.C. CLAUSS An overview of French Device Regulations in Relation to the Rest of Europe. Regulation of Medical Devices and Surgical Products in Europe EUCOMED, Brussels, 9/10.03.87 21. L.C. CLAUSS Regulatory aspects and Pharmacopeial Compliance of Polymeric Materials. Scientific Program, DC Pharma Lab opening Conference 02.09.1987 22. L.C. CLAUSS Co Chairman with Pr Williams and M. Reinikainen of the R.A.P.S. International Conference on Biosafety and Biocompatibility of Medical Devices. Nice (France) 14-15 Juillet 1988 23. L.C. CLAUSS Comparaison des diff辿rents syst竪mes dhomologation de mat辿riel m辿dico-chirurgical, l辿tude dans la CEE - Perspectives davenir. 4竪 rencontre Conditionnement et Sant辿 Pr辿sidence Pr. Pellerin et Pr. Marty Paris (France) 14 juin 1988 24. M. ROSDY, L.C. CLAUSS Cytotoxicity testing of wound dressings using normal human keratinocytes in culture JOURNAL OF BIOMEDICAL MATERIAL RESEARCH, vol 24, N属3, March 1990 25. M. ROSDY, L.C. CLAUSS Evaluation of cytocompatibility and growth promotion of drug releasing silicone wound dressings using cultures of normal human keratinocytes in defined medium BIOMAT Bordeaux (France) 17, 18, 19 Octobre 1988 26. L.C. CLAUSS French regulations of medical devices and surgical products. IBC New orleans (USA) 14 et 15 novembre 1988 27. L.C. CLAUSS Biosafety and Biocompatibility of Medical Devices : New Approach Workshop on the European Standardization of Medical Devices. CEN/CENELEC Brussels 12, 13, 14 D辿cembre 1988
  • 4. Biblio 09 27 2011 4 28. L.C. CLAUSS, V. DE ALMEIDA 束 French Regulations of Medical Devices and Surgical Products 損. 1988-1992 - Medical devices labelling harmonisation. EUCOMED. Frankfurt - 16, 17 f辿vrier 1989 29. L.C. CLAUSS, V. DE ALMEIDA Economic considerations in the control of ethylene oxide sterilisation. Ethylene oxide sterilisation. EUCOMED Paris 20, 21 avril 1989 30. L.C. CLAUSS Chairman of the R.A.P.S. International conference on the 束 Clinical trials with drugs and devices: A rational approach 損. Nice 18, 19 mai 1989 31. M. ROSDY and L.C. CLAUSS Terminal Epidermal differentiation of human keratinocytes grown in Chemically defined Medium on inert filter substrates at the Air- Liquid Interface. The Journal of Investigative Dermatology 95 : 409-414 ; 1990 32. M. ROSDY and L.C. CLAUSS Evaluation of cytocompatibility and growth promotion of drug releasing silicone wound dressings using cultures of normal human keratinocytes in defined medium. Organes artificiels hybrides C. Baquey B. Dupuy Eds. INSERM Vol 177, 171-180 (1989) 33. L.C. CLAUSS and J.D. NURY Essais Cliniques ou Evaluation Clinique du Mat辿riel m辿dico- chirurgical lH担pital ? Perspectives internationales du point de vue de lindustriel. ORPHEM, 束 Essais Cliniques des M辿dicaments, Mat辿riel M辿dico- chirurgical : Normes - R辿glementations 損. 30, 31 Mars 1990 34. L.C. CLAUSS New Application of Silicone in the field of Drug Delivery System. C.H.I. FRANKFURT 8-9 October 1990 35. L.C. CLAUSS Aspects R辿glementaires du d辿veloppement de dispositifs M辿dico- chirurgicaux pr辿par辿s au moyen de Biomat辿riaux. USA, JAPON, EUROPE SYNBIO LYON 17-19 Octobre 1990
  • 5. Biblio 09 27 2011 5 36. L.C. CLAUSS International regulatory controls and standards, U.S.A., JAPON, EUROPE BIOCERAMICS and the HUMAN BODY FAENZA Avril 2-5th 1991 37. M. ROSDY, B. GRISONI and L.C. CLAUSS Proliferation of normal human keratinocytes on silicone substrate BIOMATERIALLS, 12 511-517 ; 1991 38. L.C. CLAUSS (chairman) Biological evaluation of medical and dental materials and devices: Selection of tests Workshop, Strategy of testing. VI WORLD CONGRESS ON BIOMATERIALS BERLIN APRIL 25-27th , 1992 39. L.C. CLAUSS Biological evaluation of medical and dental materials and devices : Selection of tests. PRINCIPLE OF BIOCOMPATIBILITY RAPS INTERNATIONAL PARIS OCTOBER 7-9th , 1992 40. L.C. CLAUSS Reimbursement and pricing for medical devices in Europe. I.B.C. February 16th 1998 41. L.C. CLAUSS Integration of economical studies for reimbursement in the course of clinical trials. RAPS INTERNATIONAL LONDON February 1998 V ANNUAL CONVENTION 42. L.C. CLAUSS Funding and Reimbursement issues in Europe Symposium on Reimbursement and pricing for medical devices in Europe. I.B.C. Brussels February 25th 2000 43.L.C. CLAUSS Funding and Reimbursement in Europe, Industry point of view regarding Health Care Technology Assessment. RAPS INTERNATIONAL VIENNA, VI ANNUAL CONVENTION May 9th , 2000
  • 6. Biblio 09 27 2011 6 44.L.C. CLAUSS Health Care Technology Assessment in Europe. A Medical devices Industry perspective. ISTHAC 16th International Conference den Hague June 18th , 2000 45. L.C. CLAUSS Remboursement et Prise en charge des dispositifs M辿dico- Chirurgicaux en Europe. Point de vue de lIndustrie Europ辿enne Euroforum Paris June 20th, 2 000 46. L.C. CLAUSS What is Health Care Technology Assessment ? Why should the Medical Devices Industry be concerned ? Health Technology Assessment for Medical Devices Symposium I.B.C. London July 03rd, , 2000 47 L.C. CLAUSS Funding and Reimbursement of Borderline & Drug Delivery systems in Europe. Symposium on European Reimbursement Medical devices Management Forum . London September 14&15th , 2000 48. L.C. CLAUSS Comment int辿grer les donn辿es 辿conomiques dans le cadre des essais cliniques pour l辿valuation du services m辿dicale rendu. Euroforum, Paris November 21, 2000 49. L.C. CLAUSS Comment int辿grer les donn辿es 辿conomiques dans le cadre des essais cliniques pour l辿valuation du service m辿dical rendu. Euroforum, Paris March 20, 2001 50. L.C. CLAUSS Strat辿gie de prise en charge et de remboursement des dispositifs m辿dicaux. Euroforum, Paris March 21, 2001 51. L.C. CLAUSS Health Care Technology Assessment, Industry Point of view. IBC Brussel, April 3, 2001 52. M.Siebert, L.C.Clauss, M.Carlisle, B.Casteels, P.de.Jong, M.Kreuzer, S.Sanghera, G.Stokoe, P.Trueman, A.Wenk-Lang Health Care Technology Assessment, EUCOMED Position Paper. INTL.J.TECHNOLOGY ASSESSMENT IN HEALTH CARE 18:3, 2002 53.L.C. CLAUSS ISO 14 971 Implementation of Risk Management for Medical Devices. P.D.A Paris, December 7th, 2004
  • 7. Biblio 09 27 2011 7 54.L.C. CLAUSS Chairman of the Session regarding Current process for Follow-on proteins in Europe: The BioSimilars products (362). 41 st Annual global meeting DIA, Washington, June 26-30 2005 Biotech track 55.L.C. CLAUSS BIOSIMILAR; A balanced approach: View of a Product Developer. 42 st Annual global meeting DIA, Philadelphia, June 18-22 2006 Biotech track 56.L.C. CLAUSS A Biotech developers point of view of the future of BioSimilar and FOBs: Will it be the next revolution? BioSimilars, Bringing follow-on biologics to market, IBC Zurich, June 29-30 2006. 57.L.C. CLAUSS BioSimilar in Europe Highway or dead end? RAPS Annual Global Conference, Baltimore, October 15-18 2006. Chairman of the session about BioSimilar 58 L.C.CLAUSS Future developments for the BioSimilar drug Industry in the US and EU: A Biotech developers perspective. Biogenerics 2007 Visiongain Symposium. London May 22-24 2007 59 L.C.CLAUSS Marketing and globalising Biosimilar in a competitive landscape BioLogic Europe 2007 Lifescienceworld Symposium. Geneva June 11-14 2007 60 L.C.CLAUSS Optimising Clinical program for registration in the European Union. 43 Annual meeting DIA Atlanta June 18 21 2007 Regulatory Affairs Track 61 L.C.CLAUSS A Biotech Developers point of view of the future of BioSimilar. 2nd BioPharm Asia, Singapore , IBC Sept 26-27 2007 62 L.C.CLAUSS Examining opportunities and challenges for BioSimilars in Europe. 3rd BioSimilars conference Visiongain London December 5-7 2007 63 L.C.CLAUSS Proof of Concept and level of evidence in Orphan Drug development A Biotech Developers point of view. 7th ERTC Workshop Eurordis Paris December 14 2007
  • 8. Biblio 09 27 2011 8 64. L.C.CLAUSS BioSimilars: dead end or highway to success? A personal perspective. BioSimilars 2008 , VIB Brussels February 19&20 2008 65. L.C.CLAUSS Technical Assessment and due diligence for Phamaceutical and Biotech deal. Phrmaceutical Collaboration 2008, London February 20&21st 2008 66. L.C.CLAUSS Technical Assessment and due diligence for Biotech with a specifial attention to BioSimilars Phrmaceutical Collaboration 2008, Dublin June 26&27st 2008 67. L.C.CLAUSS BioSimilars: dead end or highway to success? A personal perspective. BioSimilars 2008 , Vth Annual Informa Berlin September 10&11 2008 68. L.C.CLAUSS Chairman. BioLogic Europe 2008, Terrapin Life Science World Geneva September 16-18 2008 69. L.C.CLAUSS Specialized BioTech Companies, Opportunities, Challenges and risks. BioLogic Europe 2008, Terrapin Life Science World Geneva September 16-18 2008 70. L.C.CLAUSS Working with the FDA / EMEA Walking the Maze. BioLogic Europe 2008, Terrapin Life Science World Geneva September 16-18 2008 71. L.C.CLAUSS Using evolving regulatory pathways for drug-devices combination Phacilitate, R&D and Oncology Leaders forum San Diego October 28-30 2008 73. L.C.CLAUSS Optimising the clinical program for registration in the European Union Clinical Trial Logistic SMI London May 20-21 200972. 74. L.C.CLAUSS How huge is the threat from BioSimilar for Originators ? Phacilitate, R&D and Oncology Leaders forum San Diego October 28-30 2008
  • 9. Biblio 09 27 2011 9 75. L.C.CLAUSS Clinical Trial Registration Optimising the clinical program for registration in the European Union Conducting Clinical Trial in Europe, SMI London October 12 & 13 2009. 76. L.C.CLAUSS BioSimilars: Regulatory expectation on a global basis Is it possible to set up a global project? BioSimilars 2009 , VIth Annual Informa Berlin September November 18&19 2009 77. L.C.CLAUSS BioSimilars: Chairman BioSimilars 2009 , VIth Annual, Informa Berlin November 18th 2009 78. L.C.CLAUSS Workshop:How to construct and navigate a BioSimilar Highway to global success by overcoming Regulatory and development hurdles BioSimilars 2009 , VIth Annual, Informa Berlin November 20th 2009 79.L.C.CLAUSS Regulatory expectation on a Global bsis for Biosimilars BioSimilars 2010 , VIIth Annual, Informa , Koln June 8th 2010 80. L.C.CLAUSS Strategy for Entering the BioSimilars global Markets Highway or Dead end ?? Examining opportunities and challenges for Biosimilars in Global Markets Characterization & comparability for Biologics April 4-7th 2011 C.H.I Bethesda USA 81. L.C.CLAUSS Industry interpr辿tation of the new guideline on Biosimilars Mono- clonal Antibodies Biosimilars and Biobetters, September 26th & 27th 2011, S.M.I London, U.K
  • 10. Biblio 09 27 2011 10