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Kathy Thomas-Urban

Company:
Medical & Scientific Writing & Publication Services
Qualification:
Leader background:
Kathy B. Thomas, PhD is an independent consultant and medical writer with more than 20 years of experience in the pharmaceutical industry and academia, and with extensive knowledge of clinical trial disclosure law in the US and EU. She has worked on preparing registry entries and developing internal guidelines, and processes to assure compliance. Kathy has been part of the clinical trial disclosure and transparency landscape and has frequently updated EMWA members about this fast-evolving topic through symposia presentation and publications. Kathy is an active core team member of the EMWA Clinical Trial Disclosure Special Interest group (SIG) and also of the DIA SIAG on this topic. Previously, Kathy served as the Head of Medical Writing at Altana Pharma AG in Konstanz, Germany. Kathy has a thorough knowledge of documents and processesrelated to the preparation of regulatory documents and disclosure/transparency activities whether at a pharmaceutical company or a CRO.
Workshops:
Vitamin D - an update on its relevance for medical writers and other night-owls
    Level: Area: Short Seminar
    Code: XXVITSEM Duration: 00:30:00
Recent Changes to Regulations Governing the Disclosure of Regulatory Documentation
    Level: Area:
    Code: Sym5.4 Duration: 00:25:00
Clinical Trial Registries and Public Databases - Gaining Efficiencies and Understanding Pitfalls
    Level: Area: Expert Seminar Series
    Code: ESS25 Duration:
Trial Registration and Results Reporting in Public Clinical Trial Registries: Requirements and Practical Demonstration
    Level: Foundation Area: Drug Development
    Code: DDF49 Duration: 03:00:00