BlueReg Group Commercialisation Pharmacovigilance Routine Pharmacovigilance (PV) activities BlueReg can support with routine pharmacovigilance activities for early access programs, clinical trials or post-marketing. The team can support you with : PV case processing (recordings, database entry, case translation and follow-up) Establish causality assessment for PV cases Submission to competent authorities Literature review “All these activities are carried out in full compliance with Good Vigilance Practices and local standards.” Pharmacovigilance The growing importance of pharmacovigilance (PV) can sometimes be perceived as a burden to pharmaceutical companies, who are ultimately responsible for drug safety and ensuring compliance with constantly evolving international regulations. Meeting the challenges of monitoring medical drug effects in-house can put pressure on time and resources. The slightest error in the pharmacovigilance reporting procedures can have costly and adverse consequences, not to mention their effect on patient health. Outsourcing these activities to a specialised and compliant pharmacovigilance consultancy firm is a flexible solution to the constant demands of maintaining an in-house operation. At BlueReg, our dynamic and adaptable team will help you make pharmacovigilance a more streamlined process through ongoing support and tailored feedback. We offer expert advice and bespoke consultancy to assist you with a complete range of pharmacovigilance services. Qualified Person Responsible for Pharmacovigilance (QPPV) BlueReg can provide you with a EU-QPPV (European Qualified Person Responsible for Pharmacovigilance), French QPPV and/or deputy on a permanent basis or when required (e.g.: illness, etc). You can have confidence in our qualified consultants who ensure their knowledge and training is fully maintained.. The QPPV is responsible for: Establishing and maintaining a pharmacovigilance system Preparing pharmacovigilance reports Setting-up of risk minimisation studies Answering requests from Health Authorities Providing Health Authorities with any other information relevant to product safety “All these activities are carried out in full compliance with Good Vigilance Practices and local standards.” Risk management & PV case processing Pharmacovigilance organisation and system Qualified Person for Pharmacovigilance QPPV Our experts Our team can also support you through the entire application process from development, to registration and post-approval management Dominique Patron Marie Regnat-Sauvageon Previous Associated services Specific Services for the United States BlueReg consultants can help navigate FDA regulations and provide support and advice for all your project requirements Next Associated News The French system for preventing and managing shortages The French regulation on the prevention and management of stock shortages of medicinal products is... Learn more New Appointment to our Leadership Team ! BlueReg Group is delighted to announce the appointment of Dominique Patrone as General Manager of PharmaBlue.... Learn more EMA GUIDANCE – COVID-19 Given the support given to our clients in interactions with health authorities all around the... Learn more Contact our experts today Composed of proven experts from the pharmaceutical industry, our team is ready to answer to your needs in any area of product development, commercialisation and early access programs, and life cycle management Make an enquiry About us Welcome to BlueReg, an international consulting company for the pharmaceutical industry, specializing in development, regulatory affairs, economic affairs, quality and pharmacovigilance. We have built long-term partnerships with many clients by offering them “tailor-made” services guaranteeing expert advice and efficient solutions, thus supporting their projects towards success. Our links Affiliations Careers Terms of use Privacy Policy GDPR Get in touch with us here: contact@blue-reg.com Manage Cookies This site uses cookies and gives you control over what you want to activate OK, accept all Deny all cookies Personalize