Pharmacovigilance ConferencePharmacovigilance Update: Practical Approaches to Current Challenges - Interactive Session and Workshop Series
As a Pharmacoviligance professional, it is imperative to stay on top of the evolving guidelines regarding the development of medicines. 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 good pharmacovigilance practices (GVP) guidelines, and the newest technologies that can be used to improve your organisational performance and reporting.
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| Type | Public / Private |
Contents
Reasons to Join
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 the progress made within the 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.
Who should Attend
Established professionals who are seeking to improve practical skills in key areas in pharmacovigilance, including:
- Signal management.
- Pharmacoepidemiology.
- Risk Management Plans.
- Benefit-risk assessment.
- Quality assurance.
Program Committee
- Gaby L. Danan, MD, PhD Pharmacovigilance Expert France.
- Maarten Lagendijk, MSc Pharmacovigilance Coordinator MEB, Netherlands.
- Stephanie A Millican, PhD, MSc Benefit_risk Unit Manager MHRA, United Kingdom.
- Margaret Anne Walters Director & Deputy EU Qualified Person for Pharmacovigilance Merck, Sharp & Dohme Ltd, United Kingdom.
Speakers
Gaby L. Danan, MD, PhD Pharmacovigilance Expert France.
Maarten Lagendijk, MSc Pharmacovigilance Coordinator MEB, Netherlands.
Stephanie A Millican, PhD, MSc Benefit_risk Unit Manager MHRA, United Kingdom.
Margaret Anne Walters Director & Deputy EU Qualified Person for Pharmacovigilance Merck, Sharp & Dohme Ltd, United Kingdom.
Kaatje Bollaerts, PhD Biostatistian P-95, Belgium.
Sabine Brosch, PharmD, PhD, MPharm Principal Scientific Administrator, Surveillance and Epidemiology European Medicines Agency, European Union, United Kingdom.
Katherine Donegan Pharmacoepidemiology, Research & Intelligence Unit Manager MHRA, United Kingdom.
Steve Hobbiger Vice President and QPPV, R&D GlaxoSmithKline , United Kingdom.
Olga Mariscal EU QPPV Cinfa Laboratories, Spain.
Sarah Morgan Benefit-Risk Management Group Manager MHRA, United Kingdom.
Shahrul Mt-Isa, PhD Associate Principal Scientist, HTA Statistics, BARDS Europe MSD, United Kingdom.
Jan Petracek, MD, MSc CEO PrimeVigilance and PharmInvent, Czech Republic.
Doris Irene Stenver, MD, MPA Chief Medical Officer Danish Medicines Agency, Denmark.
Phil Tregunno Signal Management Unit Manager Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom.
Dionne Usher Senior Specialist, EU QPPV Office MSD Ltd, United Kingdom.
Maria Wishart Deputy EU QPPV Astrazeneca, United Kingdom.
Inge Zomerdijk, MSc Pharmacovigilance Assessor Medicines Evaluation Board (MEB), Netherlands.
Registration Fees
| Industry Member | € 1430.00 |
| Industry Non-Member | € 1585.00 |
| Academia/Charitable/Government/Non-Profit Member (Full Time) | € 715.00 |
| Academia/Charitable/Government/Non-Profit Non-Member (Full Time) | € 870.00 |
| Tutorial: Introduction to the Role of the QPPV | €400.00 |
Registration fee includes refreshment breaks, lunches and electronic access to workshop material.
Date and Venue
May 10, 2017 9:00 AM – May 11, 2017 5:30 PM
Millennium Chelsea Harbour Hotel
Chelsea Harbour
London
SW10 0XG
United Kingdom
Reference
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