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Nimo Ahmed, MHRA, UK
Nimo plays a leading role in the Agency’s UK Medicines
Anti-Counterfeiting strategy and has spoken all over the world on
the subject of counterfeit medicines. He also represents the MHRA
and the UK on a number of international forums. Prior to joining the
MHRA, Nimo spent seven and a half years as an Army officer during
which time he was deployed on four overseas operational tours of
duty, where two roles saw him employed as an Intelligence Officer.
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Patricia Blanco, ETCO, Brazil
Patricia Blanco is the Executive Director of ETCO – Brazilian
Institute for Ethics in Competition, a non-profit organization that
congregates non-government and entrepreneurial institutions formed
by the breweries, soft drinks, tobacco, fuel distributing, medical
drugs and technology industries that aims to establish ethical
parameters for competition. They are currently working with ANVISA
(The Brazilian Government Agency in charge of health related
activities) on the tracking and authentication system of medical
drugs.
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Hugo Bonar, Irish Medicines Board, Dublin,
Ireland
Hugo is the Enforcement Manager of the Irish Medicines Board with
responsibilities in the areas of both medicines and medical devices.
He has degrees in Law and in Public Administration. He is a
qualified Attorney-at-Law (New York). He is the former Chair of the
Heads of Medicines Agencies Working Group of Enforcement Officers
and a member of the Management Committee of the Permanent Forum on
International Pharmaceutical Crime.
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Andrew John Charvill, Analytical Assessor,
Medicines Testing Scheme, MHRA, UK
Andy Charvill is a chemist by training and has worked at the
Medicines and Healthcare products Regulatory Agency (MHRA), the UK
Competent Authority, as the Analytical Assessor for the Medicines
Testing Scheme (MTS), since 1994. Prior to this Andy was employed in
a variety of Quality Control/Quality Assurance positions in the
Pharmaceutical Industry, principally in the manufacture of Large
Volume Parenterals.
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Frederick L. Fricke, Director, Forensic
Chemistry Center, U.S. Food and Drug Administration (FDA),
Cincinnati, OH, USA
In 1962, Mr. Fricke joined the FDA as a chemist. He was appointed as
National Expert in Emission Spectroscopy in 1978. In 1980, he was
selected for the position of Director of the Office of Regulatory
Affairs – Elemental Analysis Research Center. In 1990, he was named
Director of FDA’s Forensic Chemistry Center in Cincinnati. As
Director, Mr Fricke is responsible for the direction and
coordination of all activities for the Forensic Chemistry Center. He
established and is currently a member of the International
Laboratory Forum on Counterfeit Medicines. This Forum is a
collaborative effort with scientists from England, Germany,
Australia, Canada, Singapore, Austria, Switzerland, the Netherlands,
and the United States to detect counterfeit and unapproved
pharmaceuticals.
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Jean-Michel Guirado, Amgen, The Netherlands
Jean-Michel is Senior Manager Brand Protection at Amgen since
October 2008 in Breda, The Netherlands. He is responsible for the
Brand Protection program for Amgen’s international markets. He also
represents Amgen in the Anti-Counterfeiting Ad Hoc Working Group of
EFPIA. Engineer in Materials Physics by education, Jean-Michel
Guirado has over 12 years of experience in the pharmaceutical
industry within various functions in Process Development and Medical
Device Engineering. Prior to his positions in the pharmaceutical
industry, Jean-Michel has had managerial responsibilities for
Product Development, Project Management, Process Validation and
Quality in the automotive industry.
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Prof Dr Ulrike Holzgrabe, University of
Würzburg, Würzburg, Germany
Ulrike Holzgrabe holds a chair in Pharmaceutical Chemistry at the
University of Würzburg and is a member of several national an
international committees dealing with the German and European
Pharmacopoeia. Thus, she is interested in modern analytical methods
for quality assurance of drugs.
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Dr Dries de Kaste, RIVM, The Netherlands
Dr Dries de Kaste, pharmacist by training, is head of the
governmental laboratory responsible for the quality control of
medicines and the analysis of counterfeit drugs. He is a member of
the Dutch delegation of the European Pharmacopoeia Commission.
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Dr Sabine Kopp, World Heath
Organization (WHO), Geneva, Switzerland
Sabine Kopp, Ph.D., has worked in various positions within the WHO,
including Secretary for the International Nonproprietary Names (INN)
Programme, Acting Team Coordinator for Quality Assurance and Safety
of Medicines, in the Department of Essential Drugs and other
Medicines. She is Secretary of the WHO Expert Committee on
Specifications for Pharmaceutical Preparations and is responsible
for the normative work related to Drug Quality Assurance within WHO.
Dr Kopp is Programme Manager of the WHO Medicines Quality Assurance
and Anti-Counterfeiting Programmes. In addition she acts as
Secretary ad interim of the International Medical Products
Anti-Counterfeiting Taskforce (IMPACT).
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Dr Thomas Lenhard,
Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany
Dr. Lenhard joined one of the Sanofi-Aventis predecessor companies
in the area of quality control for development products in 1986. He
made the next steps during his professional carrier by taking
responsibility for various managerial positions within the local and
global quality control, quality assurance and supply chain
functions. Since 2005 he is in charge of Quality at the site
Distribution Platform Frankfurt, DP FRA, within the Sanofi-Aventis
Deutschland GmbH.
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Dr Chris Oldenhof, DSM
Anti-Infectives, Delft, The Netherlands
Chris Oldenhof holds a Ph.D. in organic chemistry. He is currently
Manager External Regulatory Affairs at DSM, Delft, The Netherlands.
In his 30 years with DSM he has held positions in R&D, Marketing &
Sales and Regulatory Affairs. Within CEFIC (European Chemical
Industry Council) he is the President of APIC (Active Pharmaceutical
Ingredients Committee) and a Board Member of the EFCG (European Fine
Chemicals Group). In addition, on behalf of APIC, he is a member of
the Council of Europe’s ad hoc Working Group on Counterfeit
Medicines since its foundation in 2003.
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Dr James H. Rittenburg,
Authentix Inc., USA
Dr Rittenburg joined Authentix in 1994 and is currently Vice
President of the company’s Healthcare and Life Sciences division. He
has over 25 years experience developing diagnostic systems for
detecting trace levels of chemicals in samples including
pharmaceuticals, foods, beverages, petrochemicals, and agricultural
products. He has edited several books, authored numerous journal
articles and is an inventor on a number of patents in this field.
Dr. Rittenburg has worked with many of the leading pharmaceutical
manufacturers to design and implement product security systems.
Prior to joining Authentix, Dr. Rittenburg was Director of Product
Development for Quantix Systems.
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Dr Stephan Schwarze, Bayer Schering Pharma AG,
Berlin, Germany
Stephan Schwarze started his career at Schering AG Berlin in 1992
and is now heading the function Counterfeit Protection Management
since 2005. First within Schering AG Berlin and nowadays within
Bayer Schering Pharma AG. He is a member of WHO IMPACT‘s Technology
Subgroup as well as of EFPIA‘s Anti-Counterfeiting ad hoc working
group.
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Nathalie Tallet, sanofi-aventis,
Tours, France
Nathalie Tallet is Head of the Anti Counterfeiting Central
Laboratory of Sanofi-Aventis group since September 2007 in Tours,
France. She has a Master Degree in Manufacturing Healthcare Products
and Pharmaceutical Development from Pharmaceutical Sciences
University, Bordeaux, France and has worked at Sanofi-Aventis since
1993 in various roles in co-ordination of pharmaceutical activities.
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Dr Christian Tillmanns,
meyer//meisterernst Rechtsanwälte, Munich
Dr. Christian Tillmanns is a lawyer specialized in pharmaceutical
and medical devices law. After traineeships in the legal departments
of pharmaceutical companies as SmithKline Beecham (Glaxo) and Pfizer
as well as in the pharmaceutical law department of an international
law firm and more than 6 years practise in the law firm Kaltwasser
Rechtsanwälte (specialized Advisors in pharmaceutical and health
care law) he joined the Munich law firm meyer//meisterernst in the
beginning of 2008. Dr. Tillmanns supports companies in all questions
concerning pharmaceutical law (regulatory and marketing affairs),
including representing the clients in legal proceedings
(particularly in unfair competition and pharmaceutical advertising
law).
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