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Joint MHRA/DIA Excellence in Pharmacovigilance: Clinical Trials and Post-Marketing

The 5 days of training include a comprehensive overview of the core processes and systems in place and the latest news on the international harmonisation and standardisation activities in pharmacovigilance. Now available in individual Modules.


Faculty

  • Gaby L. Danan, MD, PhD

    Gaby L. Danan, MD, PhD

    • Pharmacovigilance Expert
    • GLD, France

    Gaby Danan, MD, PhD, was the EU QPPV for Sanofi until his retirement in 2010. He has served on the Council for International Organizations of Medical Sciences and International Conference on Harmonisation Expert Working Groups, as the European Federation of Pharmaceutical Industries and Associations Clinical Safety E2B topic leader and co-chaired the EudraVigilance Expert Working Group from its inception until 2009. Dr. Danan co-published the Roussel Uclaf Causality Assessment Method for drug-induced liver injury, has authored papers on pharmacovigilance definitions and methodologies, chaired the DIA 2010 Annual Meeting, serves on the DIA Safety Training Committee, and instructs several DIA training courses.

  • Phil  Tregunno

    Phil Tregunno

    • Group Manager, Vigilance, Intelligence and Research Group
    • Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

    Phil is the Group Manager of the MHRA's Vigilance Intelligence and Research Group (VIRG) and has over sixteen years of experience working in pharmacovigilance. Prior to his current role Phil spent nine years leading and developing the Signal Management function, including systems, processes, and relevant aspects of Pharmacovigilance Legislation. He is responsible for the operational delivery of the Vigilance, Intelligence and Research Group, including delivery of relevant aspects of the Agency’s digital transformation programme. Phil led the development and delivery of the EU’s Innovative Medicines Initiative WEB-RADR Project which investigated the use of mobile applications and social media for pharmacovigilance.

  • Mick  Foy

    Mick Foy

    • Head of Pharmacovigilance Strategy
    • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

    Mick Foy is Head of Pharmacovigilance Strategy at the MHRA. Among is responsibilities is the running of the UK ADR reporting system and signal detection activities. Mick is also leads the MHRA's work with WHO and the Bill and Melinda Gates Foundation on capacity building in low and middle income countries. Mick is the current Chair of the MedDRA Management Committee and is a board member of the Uppsala Monitoring Centre.

  • Michael  Forstner, PhD

    Michael Forstner, PhD

    • Senior Vice President, Head of Risk Management and Pharmacoepidemiology
    • PrimeVigilance, Switzerland

    Michael's main focus areas are the planning, development, implementation and evaluation of benefit-risk management solutions, as well as the optimization of processes around benefit-risk management. He is engaged in developing and applying (benefit-) risk analysis methodologies in order to make RM planning more formally reproducible. Furthermore, he supports the development, implementation and evaluation of effectiveness of additional risk minimization and PV measures in the context of RMPs, as well as post-authorization studies to optimize the benefit-risk profiles of medicines.

  • Amy  Marriott

    Amy Marriott

    • Associate Director – Regulatory Compliance
    • J&J BioResearch Quality & Compliance, United Kingdom

    Ms Marriott is leading/supporting and executing the Regulatory Authority Inspection strategies (communication, preparation, conduct & hosting, responding and follow-up) as well as supporting the development/optimization and executing the GXP mock inspection program. She is also leading/supporting Inspection management strategies & activities for critical GXP inspections.

  • Julie  Williams, PhD

    Julie Williams, PhD

    • Expert Assessor
    • MHRA, United Kingdom

    She has worked in pharmacovigilance for almost 17 years having the joined the then Medicines Control Agency in 1998. Following realignment and formation of the MHRA she became a Unit Manager within the Risk Management Group and held that role until September 2013. She has been actively involved in providing expert advice to the UK representative at the Council Working Group influencing the UK’s position at the negotiations on the EU Pharmacovigilance legislation and more recently involved in work on transposition of the EU Directive into national legislation. Since September 2012 she has been the UK delegate of the EU PRAC and been actively involved in the work of the committee.

  • Louise  Larham

    Louise Larham

    • Periodic Reports Officer, Global Regulatory Affairs and Safety
    • Amgen Limited, United Kingdom

    Lu Larham has worked in pharmacovigilance for over 14 years and is a Director of Global Safety at Amgen Ltd. Lu is currently the business process owner for periodic aggregate safety reporting. She has also worked in safety surveillance, safety compliance and quality management. Prior to joining Amgen, Lu worked at the Medicines Control Agency and in the Global Clinical Safety and Pharmacovigilance group at GSK. Lu holds a BSc (Hons) in Pharmacology from the University of Bristol and a Post-Graduate Certificate in Pharmacovigilance and Pharmacoepidemiology from the London School of Hygiene and Tropical Medicine.

  • Katherine  Donegan

    Katherine Donegan

    • Pharmacoepidemiology, Research & Intelligence Unit Manager
    • Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

    Katherine Donegan holds a PhD in statistics and spent 4 years working for the UK Medical Research Council in HIV research, working with both clinical trial and observational data. She joined the MHRA in 2010 and now manages the Pharmacoepidemiology research and Intelligence Unit. She has worked on a range of drug safety issues, including vaccines, with a recent focus on new approaches to proactive pharmacovigilance and monitoring outcomes and the effectiveness of risk minimisation measures using electronic healthcare record data.

  • Sophie  Reeve

    Sophie Reeve

    • Pharmacovigilance Information Co-ordinator
    • Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

    Sophie have been working at the MHRA for over 4 years and is currently a team co-ordinator within the MHRA’s Vigilance Intelligence and Research Group (VIRG). Sophie’s team have responsibility for handling ADR data, signal detection and the evaluation of safety signals for established medicines and responding to PV enquiries. Alongside these responsibilities, Sophie has additional roles in the maintenance of the terminologies used by the unit including the MHRA Drugs Dictionary and MedDRA. She has also had important roles in the integration of electronic reporting into clinical IT systems in the UK.

  • Anna  Adams, PhD

    Anna Adams, PhD

    • GPvP Inspector, Inspection, Enforcement & Standards
    • Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

    Anna joined the MHRA as a PV Inspector at the start of 2016 having previously worked as a PV Scientist in industry. In her previous work she was involved in many aspects of PV operations and her experience includes end-to-end handling of ICSRs; identifying and implementing process improvements; and the quality management system. Prior to this, Anna completed a PhD in Chemistry with Molecular Biology at University College London as part of the Wellcome Trust Interdisciplinary PhD programme. During Anna’s undergraduate Masters’ degree in Chemistry, she had multiple placements, both in industry, and at the MHRA in the Vigilance and Risk Management of Medicines (VRMM) division, where she started her career in pharmacovigilance.

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