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Course 1: EU Inspections and Audit Readiness Plans


Instructors

  • Megann  Looker

    Megann Looker

    • Director, EU/RoW Labelling and Advertising/Promotion
    • United Kingdom

    Megann Looker (BA Hons) is Associate Director, Global Labelling at Jazz Pharmaceuticals, based in Oxford, UK since August 2016. She graduated from the University of Reading in 2001 after studying Classics, English Literature and Sociology, and found her way into Regulatory Affairs whilst planning a career in teaching. Megann was previously Associate Director of Regulatory Labeling at Celgene for the EMEA region from 2009-2016 and prior to this was in Regulatory Affairs at Wyeth and Apotex. She is a member of the InterAssociation Task Force for IDMP, eLabelling, and DIA SIAC Patient Information.

  • Kiernan  Trevett

    Kiernan Trevett

    • Senior Pharmacovigilance Inspector, Enforcement and Standards
    • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

    Kiernan Trevett has worked as a GPvP Inspector at the Medicines and Healthcare products Regulatory Agency since April 2012. She has contributed to the development of the EU Good Pharmacovigilance Practices (GVP) and has had a role in the training of GPvP Inspectors in other EU Member States. Before joining the MHRA, Kiernan worked as a certified Quality Assurance auditor for a central laboratory that provided services for Phase I-III pharmaceutical clinical trials. Kiernan has a Master of Biomedical Sciences degree from the University of Southampton and a Post-graduate Certificate in Pharmacovigilance.