Pharmacovigilance Conference Follow Verify

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

Pharmacovigilance Conference
Date	May 10, 2017 9:00 AM – May 11, 2017 5:30 PM
Place	Millennium Chelsea Harbour Hotel Chelsea Harbour London SW10 0XG United Kingdom

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 organisational performance and reporting.

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

Seven 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.

The conference is specially designed for established professionals who are seeking to improve practical skills in key areas in Pharmacovigilance , including signal management, pharmacoepidemiology (how the pharmacoepidemiological approaches support risk management), regulatory and practical challenges of the risk management plans, benefit risk assessment (what and how to do in practice) and quality assurance. also the program highlights the progress and insights that have been made within new EU project WEB-RADR on Pharmacovigilance and social media.

Agenda

Day 1 09 May

• 2017 12:00 PM — 5:00 PM Tutorial: Introduction to the Role of the QPPV
• 1:00 PM — 2:00 PM SESSION 1: REGULATORY AND LEGAL OVERVIEW
• 2:00 PM — 2:30 PM SESSION 2: PREPARATION FOR THE QPPV ROLE
• 3:00 PM — 3:45 PM SESSION 3: DAY TO DAY QPPV ACTIVITIES IN LARGE COMPANIES
• 3:45 PM — 5:00 PM SESSION 4: DAY TO DAY QPPV ACTIVITIES IN SMALL COMPANIES/FOR A CONTRACT QPPV

Day 2 10 May 2017

• 9:00 AM — 10:30 AM Session 1A: Workshop on Benefit-Risk Assessment in PSUR: Discussion on Practices
• 9:00 AM — 10:30 AM Session 1B: Workshop on Benefit-Risk Key Drivers
• 11:00 AM — 12:30 PM Session 2A: Workshop on Implementation Experience and Challenges as EV Access is Gained
• 11:00 AM — 12:30 PM Session 2B: Workshop on How to Optimise Having Multiple PSMFs
• 2:00 PM — 3:30 PM Session 3: Workshops Wrap-Up
• 4:00 PM — 5:30 PM Session 4: Pharmacovigilance and Social Media

Day 3 11 May 2017

• 9:00 AM — 10:30 AM Session 5: Risk Management Plan: Challenges and Opportunities
• 11:00 AM — 12:30 PM Session 6: Pharmacoepidemiological Studies for Pharmacovigilance Plan
• 2:00 PM — 5:30 PM Session 7: Workshop on Risk Minimisation Measures and Effectiveness Evaluation

Top Authors

• Jeysel Rio D. Cawaling
• Ezat M. El-Dkak
• Singharetnam Wijeyasekaran
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