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Inhaltsbereich

Working Group Drug-Development and Healthcare

Brigitte Schwarzer-Daum
Hans-Georg Eichler

Brigitte Schwarzer-Daum (widowed Blöchl-Daum), M.D.
Associate Professor and Deputy Head,
Head of Quality Management

» Curriculum Vitae

 

 

 

Hans-Georg Eichler, M.D., M.Sc.
Professor of Clinical Pharmacology

» Curriculum Vitae



Members of the Department of Clinical Pharmacology are involved in national and international committees and advisory boards to transfer knowledge.

Delegation of experts to the European Medicines Agency – EMA

  • Committe for Orphan Medicinal Products (COMP): Brigitte Schwarzer-Daum previously Bernd Jilma and Hans-Georg Eichler
     
  • Committee for Advanced Therapies (CAT): Martin Brunner, previously Bernd Jilma
     
  • Scientific Advice Working Party (SAWP): Brigitte Schwarzer-Daum, previously Bernd Jilma and Hans-Georg Eichler
     
  • Additional EMA-Experts: Gerhard Garhöfer, Bernd Jilma, Michael Wolzt, Markus Zeitlinger


Committee on Reimbursement of Drugs of the Austrian Sick Funds and Social Security Association Institutions (Heilmittelevaluierungkommission – HEK)

Chair: Markus Müller, Vice-Chair: Brigitte Schwarzer-Daum
 

Scientific Committee of the Medicinal Products Advisory Council - Austrian Ministry of Health

Martin Brunner, Bernd Jilma, Gerhard Garhöfer, Markus Müller, Brigitte Schwarzer-Daum, Michael Wolzt, Markus Zeitlinger


Ethics Committee of the Medical University of Vienna

Chair: Martin Brunner

Members: Martin Bauer, Christa Firbas, Brigitte Litschauer, Brigitte Schwarzer-Daum

 

 

 

Key Publications

 

  1. Hans-Georg Eichler, Francesco Pignatti, Brigitte Schwarzer-Daum, Ana Hidalgo-Simon, Irmgard Eichler, Peter Arlett, Anthony Humphreys, Spiros Vamvakas, Nikolai Brund and Guido Rasi: Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth. CLINICAL PHARMACOLOGY & THERAPEUTICS 2020; First Published: 16 October 2020 https://doi.org/10.1002/cpt.2083
  2.  Eichler HG, Koenig F, Arlett P, Enzmann H, Humphreys A, Pétavy F. Schwarzer-Daum B, Sepodes B, Vamvakas S, Rasi G: Are novel, non randomised analytic methods fit for decision-making? The need for prospective, controlled and transparent validation: CLINICAL PHARMACOLOGY & THERAPEUTICS 2019, doi:10.1002/cpt.1638
  3. Rafael Dal-Ré, Cristina Avendaño-Solà, Brigitte Bloechl-Daum, Anthonius de Boer, Stefan Eriksson, Uwe Fuhr, Søren Holm, Stefan K James, Robert J Mentz, Emilio Perucca, Frits R Rosendaal professor Shaun Treweek: Low risk pragmatic trials do not always require participants' informed consent BRITISH MEDICAL JOURNAL 2019;364:l1092 doi: 10.1136/bmj.l1092 (Published 27 March 2019)
  4. Hans-Georg Eichler, Brigitte Bloechl-Daum, Karl Broich, Paul Kyrle, Jillian Oderkirk , Guido Rasi, Rui Ivo, Ad Schuurman, Thomas Senderovitz, Luke Slawomirski, Martin Wenzl, and Valerie Paris [Paper #2018-0405CR]:"Data rich, information poor; can we use health records to create a learning healthcare system for pharmaceuticals?" CLINICAL PHARMACOLOGY & THERAPEUTICS. 2018 Sep 4. doi: 10.1002/cpt.1226
  5. Hans-Georg Eichler, Lynn G Baird, Richard Barker, Brigitte Bloechl-Daum et al. From adaptive licensing to adaptive pathways: Delivering a flexible life-span approach to bring new drugs to patients. CLINICAL PHARMACOLOGY & THERAPEUTICS Volume 97,3, 234–246, (2015) DOI: 10.1002/cpt.59 
  6. Eichler HG*, Bloechl-Daum Brigitte*, Brasseur D, Breckenridge A, Leufkens H, Raine J, Salmonson T, Schneider CK, Rasi G. : The risks of risk aversion in drug regulation. Nat Rev Drug Discov. 2013 Dec;12(12):907-16.
     *Contributed equally to this work, corresponding author 
  7. Eichler HG, Abadie E, Breckenridge A, Flamion B, Gustafsson LL, Leufkens H, Rowland M, Schneider CK, Bloechl-Daum B*: Bridging the efficacy–effectiveness gap: a regulator’s perspective on addressing variability of drug response: NATURE REVIEWS  DRUG DISCOVERY Volume 10, July 2011, 495-506
    *Corresponding Author
     
  8.  The Committee for Orphan Medicinal Products and the European Medicines Agency Scientific Secretariat:  Outlook: European regulation on orphan medicinal products: 10 years of experience and future perspectives. European regulation on orphan medicinal products: 10 years of experience and future perspectives.: Westermark K, Holm BB, Söderholm M, Llinares-Garcia J, Rivière F, Aarum S, Butlen-Ducuing F, Tsigkos S, Wilk-Kachlicka A, N'Diamoi C, Borvendég J, Lyons D, Sepodes B, Bloechl-Daum B, et al. NATURE REVIEWS DRUG DISCOVERY 10, 341-349 (May 2011) | doi:10.1038/nrd3445
  9. Eichler HG, Bloechl-Daum B*, Abadie E, Barnett D, König F, Pearson S: Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers. NATURE REVIEWS DRUG DISCOVERY 9, (April 2010) 277-291

*Corresponding Author and Shared First Author

 
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