Curriculum Vitae
PERSONAL INFORMATION Christa Wirthumer-Hoche
WORK EXPERIENCE
October 2013- Present
January 2006-September 2013
June 1997-December 2005
15/12/2020
Head of Austrian Medicines and Medical Devices Agency
Austrian Medicines and Medical Devices Agency (Austria)
Strategic planning and management, Drug regulatory affairs (human & vet) EU/national, Marketing
authorization of medicinal products and lifecycle management (human & vet), Inspection, Vigilance,
OMCL, Medical Devices; international tasks and activities
Member of the EMA-Management Board (topic coordinator for the AR of the EMA annual activity
report and for the report on the annual EMA Budget from 03/14 - 12/15) since 03/2016 Chair of the
EMA-Management Board
HMA full member (HMA alternate 2000 - Oct. 2013)
Co-Chair of the EU-Training Network Centre
Member of the Pharmaceutical Committee
Head of Institute for Marketing Authorisation of Medicinal Products &
Lifecycle Management
Austrian Medicines and Medical Devices Agency (Austria)
Strategic planning & management, Drug regulatory affairs (human & vet) national & international,
Marketing authorization of medicinal products and lifecycle management (human & vet),
Member of the CMDh (Nov 2005 - Oct. 2013)
Chair of the ASMF-Working Group: 07/2010 - 10/2013
Austrian NTA member (1997 - 2014) and member of the NTA eCTD Interlinking group (2003 - 2013)
Member of the European Risk Management Strategy Facilitation Group (ERMS-FG) 10/2010 -
10/2013
Chair of the Austrian Scientific Board since 2009 - present.
Head of Unit for Pharmaceutical Affairs
Federal Ministry of Health (Austria)
Strategic planning & management, Drug regulatory affairs (human & vet) national & international,
Marketing authorization of medicinal products and lifecycle management (human & vet)
Member of the CPMP (1997 - 2001)
Member of the MRFG (1997 - 10/2005), Chair of the MRFG under the AT presidency (07 - 12/1998).
Nominated expert (Acquis Communautaire) to the PERF platform 1999-2004.
Member of ICH - EU Topic coordinator for ICH M4 CTD (Module 1) (1999 - 2004)
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 December 1983-May 1997 Assessor/Head of Quality Assessment
Institute for Chemical Pharmaceutical Assessment (Austria)
Assessment of the Quality Dossier, Marketing authorization of medicinal products and lifecycle
management (human & vet); Analytical control

Member of the QWP (1994 - as observer, full member 1995 - 2000).

EDUCATION AND TRAINING

September 1975-March 1981 Technical Chemistry/Biochemistry, Dipl. Ing.

Technical University of Vienna (Austria)

April 1981-July 1983 Doctoral Thesis, Dr. techn.

Technical University of Vienna in cooperation with the Insitute for Medical Physiology
(Austria)

ADDITIONAL INFORMATION

Expertise Strategic planning & management,

Drug regulatory affairs (human & vet) national & international, Marketing authorization of medicinal
products and lifecycle management (human & vet), Pharmacovigilance
Expert for the quality documentation of medicinal products (human & vet),
Expert for Active Substance Master File
Lecturing

Publications Autor of publications in the field of regulatory affairs

Projects Member of the STARS project (strengthening training of academia in regulatory sciences and
supporting regulatory scientific advices) since 03/19

Memberships DIA (Drug Information Association) - Outstanding Service Award - March 2003
Honorary Member of MEGRA (Middle European Organisation for Regulatory Affairs)
Guest lecturer at different Universities (Bonn, Krems, Vienna, Copenhagen)
Award of the Großes Ehrenzeichen für die Verdienste um die Republik Österreich - Nov. 2006
Member of the Advisory Board of European Forum Alpbach, Health Symposium 08/16 - 08/19
Member of the Advisory Board of Karl Landsteiner Society
Member of the Advisory Board of Healtcare Policy Penel (Gesundheitspolitisches Forum)
Member of the Board of Academic Advisors for Germany (BfArM, DE)

Other Relevant Information Co-Chair of the EU Network Training Center since 02/14
Vice-chair of the EMA-Management Board (03/15 - 03/16)
Member of the WHO Expert Advisory Panel on the International
Pharmacopoeia and Pharmaceutical Preparations since 09/15
Election to the Chair of the EMA Management Board March, 17th 2016
Re-elected as Chair of the EMA Management Board March, 21st 2019

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