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Drug Development and Health Care

Working Groups
  1. Department of Clinical Pharmacology
  2. Research
  3. Working Groups
  4. Drug Development
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Our team plays an active part in various national decision-making committees and advisory boards, including the local ethics committee, drug safety boards, the national drug reimbursement committee, as well as committees and working parties of the European Medicines Agency. This ensures that we keep up to date with the latest regulatory, health technology assessment (HTA), and pricing and reimbursement standards.

Experts at the European Medicines Agency – EMA

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

Commission for the Reimbursement of Medicinal Products of the Austrian Health Insurance Funds and Social Security Institutions (Heilmittelevaluierungskommission – HEK)

  • Chairman: Markus Müller, Vice-Chairman: Brigitte Schwarzer-Daum

Scientific Committee of the Medicines Advisory Board - Federal Ministry of Health

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

Ethics committee of the Medical University Vienna

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

Members of the Science Board of the Vienna Infectious Diseases Network

  • Markus Zeitlinger, Bernd Jilma

Evaluation Board pursuant to §62d ff KaKuG (Federal Ministry of Social Affairs, Health, Care and Consumer Protection)

  • Brigitte Schwarzer-Daum, deputy chairwoman

 

© MedUni Wien/feelimage

Ao.Univ.-Prof. Dr.med.univ. Brigitte Schwarzer-Daum (ehem. Blöchl-Daum)

Head of Drug Development and Healthcare Working Group

Deputy Head of Department, Associate Professor
Tel.: +43 (0)1 40400-29810; 49570
E-Mail: brigitte.schwarzer-daum@meduniwien.ac.at

Selected scientific publications

  • Dal-Ré R, Bottieau E, Launay O, Rosendaal FR, Schwarzer-Daum B. Challenges in conducting efficacy trials for new COVID-19 vaccines in developed countries. CLINICAL TRIALS. 2024;0(0).

    https://journals.sagepub.com/doi/10.1177/17407745241238925

  • Hans-Georg Eichler, Michael Kossmeier, Markus Zeitlinger, and Brigitte Schwarzer-Daum*. "Orphan drugs’ clinical uncertainty and prices: addressing allocative and technical inefficiencies in orphan drug reimbursement." FRONTIERS IN PHARMACOLOGY 14: 60. 26 January 2023

    https://doi.org/10.3389/fphar.2023.1074512

    *Corresponding Author

  • Rafael Dal-Ré, MD, Prof Raphaël Porcher, PhD, Prof Frits R. Rosendaal, MD, Prof Brigitte Schwarzer-Daum, MD  Regulatory agencies disregard real-world effectiveness evidence on product labels beyond what is reasonable

    JOURNAL OF CLINICAL EPIDEMIOLOGY  November 09, 2022

    https://doi.org/10.1016/j.jclinepi.2022.11.007

  • Hans-Georg Eichler, Mark Trusheim, Brigitte Schwarzer-Daum, Kay Larholt, Markus Zeitlinger, Martin Brunninger, Michael Sherman, David Strutton, Gigi Hirsch: Precision reimbursement for precision medicine: using real-world evidence to evolve from trial-and-project to track-and-pay to learn-and-predict

    CLINICAL PHARMACOLOGY & THERAPEUTICS 2022, 111(1): 52-62 https://doi:10.1002/cpt.2471

  • Rafael Dal-Ré, Raphaël Porcher, Frits R Rosendaal, Brigitte Schwarzer-Daum: It is time to include real-world effectiveness data on medicinal product labels

    THE LANCET RESPIRATORY MEDICINE  Published: January 10, 2022 DOI: https://doi.org/10.1016/S2213-2600(22)00003-0

  • Maria E. Sheean, Frauke Naumann-Winter, Giuseppe Capovilla, Maria Elisabeth Kalland, Eva Malikova, Segundo Mariz, Darius Matusevicius, Robert Nistico, Brigitte Schwarzer-Daum, Stelios Tsigkos, Kyriaki Tzogani, Kristina Larsson, Armando Magrelli and Violeta Stoyanova-Beninska:

    Defining Satisfactory Methods of Treatment in Rare Diseases When Evaluating Significant Benefit–The EU Regulator's Perspective

    FRONTIERS IN MEDICINE, 27 August 2021 https://doi.org/10.3389/fmed.2021.744625

  • Rafael Dal-Ré, Linda-Gail Bekker, Christian Gluud, Søren Holm, Vivekanand Jha, Gregory A Poland, Frits R Rosendaal, Brigitte Schwarzer-Daum, Esperança Sevene, Halidou Tinto, Teck Chuan Voo, Nadarajah Sreeharan:  Ongoing and future COVID-19 vaccine clinical trials:  challenges and opportunities  LANCET INFECTIOUS DISEASES 2021 Published Online May 18, 2021

    DOI: https://doi.org/10.1016/S1473-3099(21)00263-2