Pharmacovigilance Business Model - A DETAILED STUDY OF THE PHARMACEUTICALS FROM THE MANUFACTURER TO THE CUSTOMER

Yash Halvawala

Master's thesis

Abstract:

Like in any other businesses manufacturing and providing the goods, eatables to the market, requires certifications, legalizing procedures etc. there is the field of Pharmaceuticals, which also need to fulfil numerous guidelines before making sale of their product in the market. In, recent years there has been emergence of this new field in the business of pharmacy known as Pharmacovigilance. The pharmacovigilance is that sector of business which is the bridge that connects the pharmaceutical company with the pharmacies and chemist shops. The European Medicines Agency (EMA) coordinates the European Union (EU) pharmacovigilance system and operates services and processes to support pharmacovigilance in the EU. As quoted by EMA, Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. This business model contains in total 6 organs like, Quality Assurance (QA), Pharmacovigilance (PV), Regulatory Affairs (RA), Distribution, Human Resources (HR) & Finance.

Keywords

European Medicines Agency (EMA), Medicines & Healthcare products Regulatory Agency (MHRA), Co-ordination Group for Mutual Recognition and Decentralized Procedures – Human (CMDh), Heads of Medicines Agencies (HMA), Quality Assurance (QA), Pharmacovigilance (PV), Regulatory Affairs (RA)

Language used: English

Date on which the thesis was submitted / produced: 25. 11. 2023

Thesis defence

• Date of defence: 6. 2. 2024
• Supervisor: Wilem Heijman
• Reader: Ludka Fyles, externi

Czech University of Life Sciences Prague

Faculty of Economics and Management

Master programme:
Business Administration