QPPV offers Human and Veterinary Pharmacovigilance, 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 Pharmacovigilance Department, partnering with Pharma and Biotech companies to support design, set-up and maintain their Pharmacovigilance 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 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.

QPPV has partnered with biologit to offer artificial intelligence ennabled solutions to tackle the cost and complexity of active safety surveillance.

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LEADERSHIP

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 decade.
Over 25 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

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HUMAN AND VETERINARY PHARMACOVIGILANCE CONSULTANCY SERVICES

EEA 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.

CONSULTANCY SERVICES

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.

SERVICE OFFERINGS

EEA QPPV and Deputy
RP for Pharmacovigilance in Clinical Trials
Pharmacovigilance Oversight and Governance
Interim Management Solutions
Scientific Literature Monitoring
Aggregate Reporting
Artificial Intelligence Systems Development and Automation
Audit / Due Diligence / Gap Analysis / Inspection Readiness
Individual Case Safety Report Management
Pharmacovigilance Agreement Management
Pharmacovigilance, Design, Set-up and Implementation
PharmacovigilanceSystem 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
Training

Vision
"Better, safer, obtainable and affordable health and wellbeing for all, now and for future generations"

Mission
"Serve consumers and make a meaningful difference. Focus on improving lives by supporting companies to develop and deliver safer products"

Values
"do well – do good – do ethically – do with integrity – do together"

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