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:
- 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)
- Gain tips to implement the new GVP guidelines
- Learn how to put Benefit-risk assessments into practice
- Delve into progress made within new EU project WEB-RADR on pharmacovigilance and social media
- Uncover the current regulatory and practical challenges of the Risk Management Plan and how you can identify potential improvements
- Discuss how the latest Pharmacoepidemiological approaches support risk management
- 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.
Who should attend?
Established professionals who are seeking to improve practival skills in key areas in pharmacovigilance, including:
- Signal management
- Risk Management Plans
- Benefit-risk assessment
- Quality assurance
Gaby L. Danan, MD, PhD • Pharmacovigilance Expert
Maarten Lagendijk, MSc • Deputy EU QPPV
MSD B.V., Netherlands
Stephanie A Millican, PhD, MSc • Benefit_risk Unit Manager
MHRA, United Kingdom
Margaret Anne Walters • Deputy EU Qualified Person for Pharmacovigilance
Merck, Sharp & Dohme Ltd, United Kingdom