Mercure Amsterdam City Hotel

May 27, 2024 8:00 AM - May 28, 2024 5:30 PM

Joan Muyskenweg 10, 1096 CJ Amsterdam, Netherlands

Advanced Workshop: QPPV Toolbox - Your Key to Success

JUST A FEW SEATS LEFT! The face-to-face workshop discussions led by our expert Shelley Gandhi, Strategic Advisor for Pharmacovigilance and Drug Safety at NDA Group in the UK will enable QPPVs to address and solve problems in their daily business more efficiently.

Overview

The face-to-face workshop is designed to maximise interaction and discussions within small groups, based on suggestions from people in QPPV roles and led by our expert instructor.

The workshop discussions will enable you to address and solve problems in your daily business more efficiently.

You will learn how to adopt the right mindset and the right thinking processes to deliver positive results while learning from the experience of your peers in similar situations.

 

 

 

 

 

Participant Testimonials

The course was great, really informative and a great chance to network. All the materials provided will be good reference documents. The trainer was very informative and approachable and the venue was spot on. – Simon Ellis – EU QPPV, Procter & Gamble, Inc.

I think attending training with Shelley Gandhi is always a guarantee for success. – Barbara Del Carlo – Deputy EU QPPV, Argenx, BE

Featured topics

    • Systems accountability
    • Regulatory confidence in the quality of the PSMF
    • Oversight of the Case Management process
    • Policies for medication errors, misuse and lack of effect
    • Quality, accuracy, completeness and timelines of PSURs/PBRERs, RMPs and design of RMMs
    • Oversight of PASS processes
    • Safety Governance processes
    • Interface with RA: Best team-working practices
    • Investigator-initiated research, market research and patient support programmes
    • QPPV inspection and audit readiness

Who should attend?

This workshop is aimed at QPPVs who are already established in their role and seek to further improve their daily practice.

 

Learning objectives

  • At the conclusion of this workshop, participants will be able to:

    • Identify the requirements for marketing authorisation holder and QPPV
    • Discuss how to prepare for and conduct the audits and inspections
    • Navigate the changes in the QPPV role within a global commercial environment
    • Identify elements of the pharmacovigilance system
    • Describe components of a complete pharmacovigilance system: including a QPPV back-up and delegating pharmacovigilance activities

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