プロフィール詳細

プロジェクトを作成

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Dr. Katrin W.に依頼

Germany

Senior Regulatory Affairs Expert & PhD Scientist | Medical & Scientific Writing

プロフィール概要

As a PhD-level scientist with over 15 years of experience in biotechnology, vaccine development, and medical devices, I specialize in bridging the gap between complex R&D data and regulatory compliance. My expertise spans the entire product lifecycle—from molecular design and process development to international registrations (EU MDR, ASEAN, GCC). Currently, I lead Regulatory Affairs projects for Class IIb medical devices, focusing on the authoring and review of Technical Documentation, Biological Evaluation Reports, and Risk Management files (ISO 14971). My background as a Senior Scientist at Bavarian Nordic and my doctoral research on viral immunology provide me with a deep understanding of aseptic processing, method validation, and clinical data interpretation. I am passionate about translating intricate laboratory and production data into clear, actionable, and compliant documentation to ensure timely market access for innovative healthcare products.

専門分野

• ☆ Drug Discovery
• ☆ Phenotypic Assays
• ☆ Drug Development
• ☆ Bioanalytical Testing
• ☆ Vaccine Development
• ☆ Pharmaceutical Manufacturing
• ☆ Extractable & Leachable Testing
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Validation
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ Clinical Trials
• ☆ Regulatory Affairs
• ☆ Technical & Scientific Writing

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Technical Writing, Business & Legal Writing, General Proofreading & Editing

Research Gap Analysis, Scientific and Technical Research

Consulting Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis

Product Development Formulation, Recipe Development, Stability/Shelf Life Testing, Product Evaluation, Product Validation, Manufacturing, Product Compliance , Product Launch Support

職務経験

Deputy Head of Regulatory Affairs Medical Devices

Pharma Stulln (Germany)

1月 2021 - 現在

Senior Scientist

Bavarian Nordic (Germany)

12月 2016 - 2月 2020

Scientist

Bavarian Nordic (Germany)

8月 2013 - 12月 2016

学歴

Dr. (Infectious Diseases)

Universitätsklinikum Gießen und Marburg

12月 2007 - 8月 2012

Dipl. Ing (FH) (Biotechnology)

Technische Hochschule Mittelhessen

9月 2002 - 9月 2007

認定資格

• 認定資格の詳細は未入力です。

出版物

PATENT

Katrin Weidner, Evelien M Bunnik, Jerome H H V Custers, Gerrit C Scheper, Selina Khan, Markus Kalla(2019). THERAPEUTIC HPV VACCINE COMBINATIONS . MX 2018013340 A

Katrin Weidner, Evelien M Bunnik, Gerrit C Scheper, Jerome H H V Custers, Markus Kalla, Selina Khan(2019). combinações de vacina terapêutica contra o hpv . BR 112018072372 A2

JOURNAL ARTICLE

Inhaled Granulocyte/Macrophage Colony–Stimulating Factor as Treatment of Pneumonia-associated Acute Respiratory Distress Syndrome @article{lens.org/013-773-616-647-010, author = {Susanne Herold and Katrin Hoegner and István Vadász and Tobias Gessler and Jochen Wilhelm and Konstantin Mayer and Rory E. Morty and Hans-Dieter Walmrath and Werner Seeger and Juergen Lohmeyer}, title = {Inhaled Granulocyte/Macrophage Colony–Stimulating Factor as Treatment of Pneumonia-associated Acute Respiratory Distress Syndrome}, journal = {American journal of respiratory and critical care medicine}, month = {March}, doi = {10.1164/rccm.201311-2041le}, date = {2014-03-01}, note = "\url{https://www.ncbi.nlm.nih.gov/pubmed/24579839} ; \url{https://www.atsjournals.org/doi/full/10.1164/rccm.201311-2041LE}", url = {https://lens.org/013-773-616-647-010} } . American journal of respiratory and critical care medicine.

Barbara Unkel, Katrin Hoegner, Björn E. Clausen, Peter Lewe-Schlosser, Johannes Bodner, Stefan Gattenloehner, Hermann Janßen, Werner Seeger, Juergen Lohmeyer, Susanne Herold(2012). Alveolar epithelial cells orchestrate DC function in murine viral pneumonia . The Journal of clinical investigation.

Ruth Pinto, Susanne Herold, Lidija Cakarova, Katrin Hoegner, Jürgen Lohmeyer, Oliver Planz, Stephan Pleschka(2011). Inhibition of influenza virus-induced NF-kappaB and Raf/MEK/ERK activation can reduce both virus titers and cytokine expression simultaneously in vitro and in vivo . Antiviral research.

Ruth Pinto, Susanne Herold, Lidija Cakarova, Katrin Hoegner, Jürgen Lohmeyer, Oliver Planz, Stephan Pleschka(2011). Inhibition of Influenza Virus-induced NF-kB and ERK Activation can Simultaneously Reduce Both, Virus Titres and Cytokine Expression In Vitro and In Vivo . Antiviral Research.

Susanne Herold, Tannaz Shafiei Tabar, Hermann Janssen, Katrin Hoegner, Maciej Cabanski, Peter Lewe-Schlosser, Jens Albrecht, Frank Driever, István Vadász, Werner Seeger, et al.(2011). Exudate macrophages attenuate lung injury by the release of IL-1 receptor antagonist in gram-negative pneumonia . American journal of respiratory and critical care medicine.

CONFERENCE PAPER

Susanne Herold, Barbara Unkel, Katrin Hoegner, Werner Seeger, Juergen Lohmeyer(2011). Alveolar Epithelial Cells Shape Dendritic Cell Antiviral Responses By Expression Of GM-CSF In Severe Influenza Virus Pneumonia . A21. INNATE IMMUNITY.

Katrin Hoegner, Stephan Pleschka, Jens Albrecht, Frank Driever, Werner Seeger, Juergen Lohmeyer, Susanne Herold(2010). Macrophage TRAIL Expression Is IFN-ß-dependent And Mediates Alveolar Epithelial Apoptosis And Barrier Dysfunction In Influenza Virus Pneumonia . A101. INFLAMMATION AND REPAIR IN LUNG INJURY.