QPPV offers Human and Veterinary Pharmacovigilance, Cosmetovigilance and Medical Device Vigilance Consultancy Services, including the provision of European Economic Area (EEA) Qualified Person for Pharmacovigilance (QPPV) and Responsible Person for Pharmacovigilance (RPPV) in Clinical Trials, with the necessary tools, experience and expertise to support Sponsors, Marketing Authorisation Holders and Applicants.
QPPV can act as a virtual Vigilance Department, partnering with Pharma, Biotech, Medical Device and Cosmetics companies to support setting up or maintain and manage their Vigilance Systems, focusing on animal and patient safety and adhering to regulations and guidelines, developing effective strategies and designing high quality and scalable solutions.
QPPV offers highly specialised and experienced Medical, Scientific and Strategic support throughout the life-cycle of medicinal, device and cosmetic products.
QPPV is a forward thinking company and believes in the use of technology to improve and innovate processes ensuring the safe and efficacious use of medicines, medical devices and cosmetics.
QPPV has partnered with biologit to offer automated solutions to tackle the cost and complexity of active surveillance.
For more information
Nicole Baker PhD
EEA QPPV & RPPV
Immunologist and Pharmacovigilance Professional with strong focus on innovation and extensive knowledge in global legislation and guidelines for Medical Affairs, Regulatory Affairs, Pharmacovigilance and Clinical Trials, gained by leading and managing global, multi-disciplinary teams.
Extensive experience in providing strategic, operational and scientific leadership throughout the product life-cycle, from pre-clinical to post-marketing.
Experience gained supporting or fulfilling the role of EEA QPPV and RPPV in Clinical Trials over the past 10 years.
Over 20 years’ experience gained within Academia, Pharmaceutical Industry, Regulatory Authority, Clinical Research Organisation, and more recently Start-up.
Experienced Technologist and Engineering Leader with broad industry experience spanning a career of over 20 years, having performed senior engineering/engineering management roles on large scale Cloud Infrastructure, Fintech, Healthcare and Artificial Intelligence Services.
Bruno Ohana PhD
Artificial Intelligence Engineer
HUMAN AND VETERINARY PHARMACOVIGILANCE, COSMETOVIGILANCE AND DEVICE VIGILANCE CONSULTANCY SERVICES
EEA AND LOCAL QPPV SERVICES
As part of the Pharmacovigilance System, the Marketing Authorisation Holder shall have permanently and continuously at its disposal an appropriately qualified Local and EEA QPPV.
The Marketing Authorisation Holder shall ensure that the EEA QPPV has sufficient authority to influence the performance of the Quality System and the Pharmacovigilance activities of the Marketing Authorisation Holder.
The Marketing Authorisation Holder should therefore ensure that the EEA QPPV has access to the Pharmacovigilance System Master File (PSMF) as well as authority over it and is notified of any changes to it.
The authority over the Pharmacovigilance System and the PSMF should allow the EEA QPPV to implement changes to the system and to provide input into risk management plans as well as into the preparation of regulatory action in response to emerging safety concerns.
We can offer very experienced safety surveillance professionals, with the capability and expertise to advise Sponsors, Marketing Authorisation Holders or Applicants.
Combined knowledge and experience to shape and transform processes and strategies improving companies' business structure.
Above all we are proud to have helped and contributed to bring, keep and maintain safe and efficacious products to the market, promoting Patient and Animal Safety.
Local or EEA QPPV and Deputy
RP for Pharmacovigilance in Clinical Trials
Safety Oversight and Governance
Interim Management Solutions
Scientific Literature Monitoring
Artificial Intelligence Systems Development and Automation
Audit / Due Diligence / Gap Analysis / Inspection Readiness
Individual Case Safety Report Management
Medical Device Report Management
Vigilance Agreement Management
Vigilance Set-up, Implementation and Development
Vigilance System Master File Management
Post Authorisation Safety or Efficacy Studies
Quality Management Systems / Assurance
Risk Management and Benefit Risk Analyses
Signal Surveillance and Management
Support with Marketing Authorisation Application and Variations
"Better, safer, obtainable and affordable health and wellbeing for all, now and for future generations"
"Serve consumers and make a meaningful difference. Focus on improving lives by supporting companies to develop and deliver safer products"
"do well – do good – do ethically – do with integrity – do together"