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Millennium Chelsea Harbour Hotel

2017年5月10日 (水) 午前 9:00 - 2017年5月11日 (木) 午後 5:30

Chelsea Harbour, London, SW10 0XG, United Kingdom

Pharmacovigilance Conference

Pharmacovigilance Update: Practical Approaches to Current Challenges - Interactive Session and Workshop Series

概要

As a Pharmacoviligance professional, it is imperative to stay on top of the evolving guidelines for medicines development. This Pharmacovigilance Conference addresses the recently revised guidelines as well as forward-thinking strategies that you encounter in your regular course of business.
The conference will bring concrete answers and insights, through multi-stakeholder experience, to deal with the freshly released GVP guidelines, and the newest technologies that can be used to improve your organisational performance and reporting.

Recently published guidelines to be discussed:
Module II – Pharmacovigilance System Master File
Module V – Risk Management Systems

7 Compelling Reasons to join the DIA Pharmacovigilance conference:

  1. Understand the key pharmacovigilance inspection trends, plus options for improving organisation and processes - including the role of the EU QPPV and the Pharmacovigilance System Master File (PSMF)
  2. Gain tips to implement the new GVP guidelines
  3. Learn how to put Benefit-risk assessments into practice
  4. Delve into progress made within new EU project WEB-RADR on pharmacovigilance and social media
  5. Uncover the current regulatory and practical challenges of the Risk Management Plan and how you can identify potential improvements
  6. Discuss how the latest Pharmacoepidemiological approaches support risk management
  7. Improve inspection outcomes

The conference format is designed to generate dialogue and solutions through a series of interactive sessions and workshops. Discussion content will be tailored based on questions raised in advance by attendees.

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参加対象

Established professionals who are seeking to improve practival skills in key areas in pharmacovigilance, including:

  • Signal management
  • Pharmacoepidemiology
  • Risk Management Plans
  • Benefit-risk assessment
  • Quality assurance

 

Short Course or Primer

To keep you at the forefront.

2017年5月09日 (火)

Tutorial:

Introduction to the Role of the QPPV

プログラム委員会

  • Gaby L. Danan, MD, PHD
    Gaby L. Danan, MD, PHD Pharmacovigilance Expert
    GLD, France
  • Maarten  Lagendijk, MSC
    Maarten Lagendijk, MSC Deputy EU QPPV
    MSD, Netherlands
  • Stephanie  Millican, PHD, MSC
    Stephanie Millican, PHD, MSC Deputy Director Benefit Risk Evaluation, Safety and Surveillance
    MHRA, United Kingdom
  • Margaret Anne Walters
    Margaret Anne Walters Deputy EU Qualified Person for Pharmacovigilance
    Merck, Sharp & Dohme Ltd, United Kingdom

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