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Louis-Christian DR CLAUSS

PARIS

En résumé

Dr Louis-Christian Clauss,


Principal Consultant Health Care, QA&RA Biotech, Medical devices, Pharmaceuticals (Belgium)

Customers: Novartis, Kythera, Cipla, Validant etc.....
V.P Global Head QA&RA SOTIO (Prague )

Principal Consultant Health Care Hisut Ltd QA&RA Biotech, Medical devices, Pharmaceuticals (Belgium)

Former Global Director Regulatory Affairs New Product Development, BioScience, Baxter World Trade

Former V.P Boston Scientific, Becton Dickinson, Dow Corning, Clintec

Graduate both in Sciences and Business with a Master in Bio-Pharmacy, a Ph. D in Pharmacy and a degree in Business administration (IAE).

Resident Biologist in Public Hospitals before moving in the Multinational Health Care Industry both in the Medical Devices field and in the Pharmaceutical one (Institut Mérieux (Sanofi Avantis), Dow Corning, Boston Scientific, Clintec, Becton Dickinson®, Baxter), with more than 20 years experience in International Regulatory Affairs (FDA and EMEA…etc), Marketing, Business development and Product development.

Lead the development of numerous products including Pharmaceuticals, stents, implantable devices, BioTechs and BioSimilar.

Member of numerous Professional Societies e.g DIA, RAPS (former General secretary, RACS,), EUCOMED (former chairman of the FRG), APIMCA (former President elected), etc….

Published More than 80 papers and conferences (Scientific, Regulatory and Reimbursement subjects).
Specialties

Biotechnologies, Business development,
Regulatory Affairs International (EMEA, FDA Eu National)
New product development
QA, ISO certification

Mes compétences :
Biotechnology
FDA

Entreprises

  • Hisut - Founder and Head of Practice

    2008 - maintenant Head of consultancy and Principal Consultant Health Care, European Registered Qualified Person
    Hisut

    December 2009 – Present (2 years 2 months) Brussels Belgium

    . Business development & Due diligence
    . Regulatory Affairs with FDA, EMEA, Global development for Biologics, Biotechnologies, Pharmaceutical and Medical Devices
    . Business Strategy; Risk Management; New Product development Strategy;
    . Quality Assurance GMP, ISO,GCP,GLP, CE Mark
    . Registered Qualified Person (QP)
    Demonstrated record of achievements and approvals in the USA, Europe,on medical devices (classes I, II, III) –FDA approvals, PMA, 510(k), and CE-marking submissions –more than 100 submissions on pharmaceutical, biopharma, and biotech products.

    Design and implemented Quality Management Systems (14 Qa System implemented in 14 different comapnies) in compliance with FDA's QSR, 21 CFR 820, European MDD, including In Vitro and Medical Device, Implantable devices CE-marking, ISO 9001 and ISO 13485 standards. cGMP, GTP, GLP, GCP.

    Customers: BD, Baxter, LFB, Novartis vaccines, Ascendx, CYRPA, etc....

  • Hisut - Health Care Consultancy

    2005 - maintenant

  • Baxter - Director Global RA BioSciences

    Maurepas 2004 - 2008 Director RA NPD global BioScience Edit
    Baxter BioScience

    Public Company; 10,001+ employees; BAX; Pharmaceuticals industry

    March 2004 – August 2008 (4 years 6 months)

    1) Management of key Biotech projects with one BLA in 2007
    2) Technical assessment of potential acquisitions and licensing in
    3) RA due diligence for key investments in the field of Health care Biotech

    Ask for recommendations

  • Baxter International - Senior Director RA Europe, Renal division

    Maurepas 2000 - 2004 >25 product approval gained in Europe

  • Boston Scientific - Vice-President Europe QA/RA/Clinical

    Nanterre Cedex 1997 - 2000 • Create, Manage and staff the RA and Clinical functions. Establish the devices Post-market vigilance system Europe, Clinical tracking and central procedures in compliance with EN540. Manage vigilance cases throughout Europe and reimbursement issues. 94 clinical trials (> 3000 patients) conducted with success. Turnover world-wide 2 billion US$

  • Clintec (Nestle&Baxter) - Global Vice-President RA/QA

    1993 - 1997 • Create, Manage, organise and staff the global international RA and QA functions. The range includes Parenteral Pharmaceuticals, Medical Devices and Enteral products. 95 new product licenses were granted during 1995 in Asia, Europe and America, ISO 9002 and EN 46002 certification for the entire organization achieved in less than 11 months. Non-PVC dual bag (Clinimix) Global Team Leader.
    • Budget 1996 = MM$ 4.2 CLINTEC - QP releasing injectable Batch 4 injectable manufacturing sites GMP)

  • Dow Corrning - Director Europe RA/QA

    1977 - 1993 Very large number of products approval including building of the new site and its registration.

  • Assistance publique - Hôpitaux de Paris - Biogist Resident

    Paris 1972 - 1977

Formations

Réseau

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