It is now nearly two years since the implementation of the new EU Pharmacovigilance (PV) legislation, and so it is time to reflect on the impact these changes have had on the role of the Qualified Persons for Pharmacovigilance (QPPVs) and their position and relationship with Marketing Authorisation Holders and regulatory agencies. QPPVs face multiple challenges, and the 2014 meeting will provide insights from regulators as well as MAH management into the expectations these stakeholders have of the QPPV.
In addition, Good PV Guidelines are still evolving. Therefore it is vital to remain abreast of any changes likely to impact the QPPV’s essential role. Such changes may arise from updates to European requirements or outputs from evolving projects. However, how the QPPV operates is also influenced by regulatory authorities outside of the EEA (e.g. FDA) and from cross-regional initiatives such as ICH.
Key Topics Include:
• Two years later – Impact of the new EU PV requirements on the QPPV role
• Risk Minimisation – Medication beliefs and behaviours, EU requirements
• Metrics and KPIs – Support for QPPV oversight
• Networks and Communication – Sources of information for QPPVs
• Being a QPPV in Different Environments (non EU companies, contract QPPVs etc.)
• Quality Systems – Compliance with GVP Module 1
• PV Inspections – What’s new and what’s old (but still being found…)
• Operational Challenges; e.g. the PSMF, in place and meeting Regulator needs?
Who Should Attend
EEA Qualified Persons for Pharmacovigilance
Deputy Qualified Persons for Pharmacovigilance
Senior Pharmacovigilance Regulators and Inspectors CRO and Consultants providing QPPV Services
National Responsible Persons for Pharmacovigilance
Heads of Pharmacovigilance
Identify the expanded expectations of the role in the context of the new regulatory framework and transparency initiatives
Examine current areas of real challenges for the QPPV such as mergers, outsourcing, complex marketing situations and post-authorisation safety studies
Advance understanding of the legal aspects and associated liabilities for the QPPV
Learn of regulatory and inspectorate expectations of the QPPV
Share experiences to better understand how to fulfil and cope with the role of the QPPV
DIA meetings and training courses are approved by the Commission for Professional Development (CPD) of the Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society of Pharmaceutical Medicine (SGPM) and will be honoured with credits for pharmaceutical medicine. All participants are eligible for these credits and certificates are available on request from the DIA registration desk.
The QPPV Forum has been awarded with 15 CPD credits from the Faculty of Pharmaceutical Medicine (FPM) of the Royal College of Physicians (RCP) of the UK. Medical practitioners who are eligible for credits can click on http://www.fpm.org.uk/cpd/registration for more information. If you are already a CPD member, please go directly to http://cpd.fpm.org.uk to claim your credits. Certificates are available on request from the DIA registration desk.
+41 61 225 5151