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Alina Tudor, MD

Norgine Pharmaceuticals, UK

Alina Tudor graduated as Medical Doctor, from Medicine and Farmacy University in Bucharest, Romania. Alina is a seasoned Pharmacovigilance Physician working in Drug Safety for approximately 13 years, with a broad experience in risk-benefit evaluation, as well as pharmacovigilance operations, being responsible for the setting up and maintenance of various PV systems for all types of products (generics and specialty drugs, biologics, medical devices). In her current role as Senior PV Physician at Norgine, Alina is responsible for providing expert oversight into benefit-risk review of Norgine products, leading signal detection, RMP and PSUR activities, while managing various vendors. Prior to Norgine, she worked in big generic pharmaceutical companies, like Actavis and Alvogen, as well as a consultant in Voisin Consulting Life Sciences, seeing the outsourcing activity from different perspectives.

 


Abstract

Outsourcing Pharmacovigilance Activities: How to Set It Right, a MAH Perspective

  • Outsourcing PV: how and what to choose?

  • Safety activities to be outsourced vs. vendors expertise

  • Methods of oversight.

In a world of increasing demand and stricter regulations, outsourcing in pharmacovigilance has been a standard business practice for the past 10 years or more, with outsourcing models depending on the company size, providers expertise, but mostly on the fluctuating resources needs. The presentation will focus on practical aspects of the outsourcing models, leading to correct results: doing it right, efficient and scalable. It will also investigate whether one model fits all needs, and will evaluate the PV activities commonly outsourced and the reasons for why some of the activities are rarely or never outsourced. Last but not the least, the presentation will discuss about the importance of contracts and how business partnerships can strive when all involved parties know exactly what their responsibilities are, work together and trust each other. An important topic covered in this presentation is the MAH responsibility and how companies holding the Marketing Authorisation have to ensure and prove they have the correct oversight.

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