CURRICULUM VITAE. Dr. Sabine Kopp Born in Kirchheim/Teck, Federal Republic of Germany

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1 CURRICULUM VITAE Dr. Sabine Kopp Born in Kirchheim/Teck, Federal Republic of Germany Primary school in Kirchheim/Teck Classical secondary school in Kirchheim/Teck Matriculation July 1978 Language school in Interlaken (Switzerland) Study of chemistry at the Eberhard-Karls-University of Tübingen Study of pharmacy at the Eberhard-Karls-University of Tübingen Passed first part of the federal pharmaceutical examination August 1981 Internship in a pharmaceutical firm (Wala, D-Bad-Boll) Passed second part of the federal pharmaceutical examination Internship in a pharmacy ('Apotheke im Teck-Center` in Kirchheim/Teck, FRG) Research work in collaboration with Professor Graf at the Eberhard-Karls-University in Tübingen and Professor Doelker at the University of Geneva in a pharmaceutical technological subject, for a PhD thesis entitled: Study of the influence of crystallographic modifications on the properties of phenobarbital tablets 1

2 Technical assistant in the University of Tübingen work related to the preparation of the Homeopathic Pharmacopoeia (FRG) Passed third (= final) part of the federal pharmaceutical examination Acquired "Approbation" (official approval) as a German pharmacist Internship at the World Health Organization (WHO) in the pharmaceuticals unit (PHA) in Headquarters (HQ), Geneva (CH) Grant paid by the Hermann-Schlosser-Stiftung (FRG) for studies at the University of Geneva with Prof. Doelker and Prof. Buri Employed as pharmaceutical assistant in research at the University of Geneva Throughout stay in Geneva, wrote short articles for the pharmaceutical journals `Deutsche Apotheker Zeitung' and `Pharmazeutische Zeitung' PhD examination passed in: pharmaceutical technology and pharmacology ( magna cum laude ) Associate Professional Officer in the pharmaceuticals unit (PHA), WHO/HQ in Geneva, paid by Germany Pharmaceutical Officer in the WHO's pharmaceuticals unit (WHO/HQ DMP/PHA) Responsible Officer Quality Assurance, a.i. (WHO/HQ DMP/QAS) Scientist and Responsible Officer for Medicines' Quality Assurance Acting Team Coordinator, Quality Assurance and Safety of Medicines (WHO/HQ HTP/EDM/QSM) Responsible Manger for WHO's Medicines' Quality Assurance to date Programme (WHO/HQ HSS/EMP/QSM Responsible Manager for Medicines Anti-Counterfeiting to date Programme (WHO/HQ HSS/EMP/QSM) 2

3 Special functions: May January 2002 Secretary of the INN Programme Member of the WHO project group on implementation of GMP 2003 July to date Secretary for the Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations and responsible for the WHO Expert Committee on Specifications for Pharmaceutical Preparations and 12 WHO Collaborating Centres Member of the WHO project group on Counterfeit drugs Member of the WHO Headquarters Board of Appeal designated by to date the Director-General Executive Secretary a.i., International Medical Products to date Anti-Counterfeiting Taskforce (IMPACT) Areas of work: International Nonproprietary Names for pharmaceutical substances (INNs), procedures and guidelines serving the WHO-UN-UNICEF-World Bank prequalification project, development of standards and guidances in the areas of quality assurance, including The International Pharmacopoeia, Basic tests, International Chemical Reference Substances (ICRS), Good manufacturing practices (GMP), pharmaceutical starting materials certification scheme, safe trade and distribution guidelines for starting materials and products, stability testing, storage, bioequivalence and interchangeability (for details: Coordination of the WHO External Assessment Scheme for national drug quality control laboratories in collaboration with the European Department for Quality of Medicines (EDQM) in all 6 WHO regions (i.e. Africa, the Americas, Eastern Mediterranean, Europe, South-East Asia and Western Pacific) Representing WHO at official meetings and sessions of international bodies and organizations, including the: * European Pharmacopoeia Commission * International Conference on Harmonization (ICH) * Panamerican Conference on Drug Regulatory Harmonization * Pharmacopoeial Discussion Group (PDG) 3

4 * World Bank Collaboration with international organizations, such as: *International Atomic Energy Agency (IAEA) * United Nations Children's Fund (UNICEF) * World Customs Organization (WCO) * World Intellectual Property Organization (WIPO) Collaboration with WHO Member States on quality assurance related issues, as well as from for nomenclature questions; close collaboration with nomenclature commissions and Pharmacopoeial Secretariats, related national bodies and commissions: * European Medicines Agency (EMEA) * European Union (EU) * British Pharmacopoeia Commission (British Approved Names [BAN] Committee) * French Pharmacopoeia Commission (Dénominations Communes Françaises) * Japanese Adopted Names (JAN) Commission * United States Adopted Names (USAN) Council * United States Food and Drug Administration (FDA) * United States Pharmacopeia as well as numerous other national Pharmacopoeial Secretariats and Commissions worldwide, including the Argentinean, Brazilian, Chinese, Indian, Japanese, Mexican, South Korean and Thai Pharmacopoeias Assistance in the organization of the 9 th (Berlin, Germany 1999), 10 th (Hongkong, The People' s Republic of China 2002) 11 th (Madrid, Spain 2004), 12 th (Seoul, Republic of Korea 2006) and 13rd International Conference of Drug Regulatory Authorities (ICDRA) (Berne, Switzerland) Collaboration with industry worldwide related to drug nomenclature ( ) and quality assurance related issues, such as development of new guidance texts and monographs for inclusion in The International Pharmacopoeia (1986 to date) Participation in and co-charing of the WHO discussion group with International Federation of Pharmaceutical Manufacturers and Associations ( IFPMA), International Generic Pharmaceutical Alliance (IGPA) and World Self-Medication Industry (WSMI) on Drug Quality and Counterfeits ( ) WHO Focal Person for International Pharmaceutical Federation (FIP) and International Pharmaceutical Students Federation (IPSF) Designated Member of the WHO Headquarters Board of Appeal 4

5 Acting for the Team Coordinator, as well as the Director of the department Focal person for publications within Quality Assurance and Safety of Medicines team ( ) Major challenges and achievements in area of work: * Transliteration of all published INNs into Chinese and Arabic * Transition of the INN Programme from a paper to computerized environment * Standardization of presentation of the graphic formulae in INN and pharmacopoeial publications * Maintenance of the INN database and moving towards semi-automatic publication * Fundraising for normative activities, including the establishment of a user-fee system for the INN Programme * Increasing of the frequency of Expert meetings and publications to serve needs of Member States * Maintaining WHO's role in the area of quality assurance for medicines at an international scientific level through an independent worldwide consultation process Member of : International Association for Pharmaceutical Technology (APV) Féderation international pharmaceutique (FIP) Awards : FIP Fellow (2009) Special interests: Team work, cultures, people, languages, sports and reading Languages: UN proficiency examination passed In: * English (1988) * French (1988) * Spanish (1994) Mother language: German 25/11/2010 5

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WHO Expert Committee on Specifications for Pharmaceutical Preparations. How does it work?

1 WHO Expert Committee on Specifications for Pharmaceutical Preparations How does it work? Sabine Kopp, PhD Quality Assurance and Safety: Medicines Department of Medicines Policy and Standards Main points