Evaluate the Effects of Global Harmonisation - Environment Assignment Help

Assignment Task :

Chapter#1 Introduction

Research Background

Pharmacovigilance or PV as described by the World Health Organisation (WHO) is the identification, evaluation, monitoring, regulation and prevention of the adverse effects of the medicines and its related issues. In 1961, the WHO has developed the International Drug Monitoring Programme to monitor pharmacovigilance. With 2010, more than 130 countries became part of this programme. The agenda of WHO for this initiative is to make sure the safety of the consumers from the adverse effects of the drugs (WHO, 2019). European Union (EU) work with the collaboration of the European Medicines Agency to monitor pharmacovigilance in the European Union. In Europe, the experts and professionals do a meeting each month to discuss the pharmacovigilance (EMA, 2019). 

Pharmacovigilance is necessary to minimise the adverse effects of the medicines. It prevents and improves the overall health of the nation. The countries with better pharmacovigilance regulation have better public health as compared to those countries where pharmacovigilance is neglected (Saha, 2019).

Few nations validly indulge spontaneous reporting by physicians. Most states, submissions are done by the manufacturers, over its Qualified Person for Pharmacovigilance (QPPV), all reports that they get from health providers to national authorities. Many others include rigorous, dedicated courses focusing on new-found drugs, or on questionable drugs, or on the prescribing ways and pattern from groups of doctors or including pharmacists in reporting. All of these create potent valuable evidence (Bloomberg Law, 2019). So, basically people who are involved in pharmacovigilance are doctors, pharmacist, health care professionals, medical specialist, clinical pharmacists, regulatory and industry officials. All of them work towards achieving the aim of prevention of medicine related problems, reduce the mortality and morbidity rate.

Research Rationale

To choose this topic to research first because of the interest in the topic. Second, the newly developed and old drugs have an adverse effect on consumers that are mostly not identified. But some countries with well-developed health system does check and balance on the drugs and its side effects. Therefore, their pharmacovigilance regulation will be assessed and compared. To evaluate the strategies adopted by different countries this topic is chosen. The findings of this research will be helpful for improving and implementing regulation strategies.

Research Aim

This research aims to compare and evaluate the regulation of Pharmacovigilance in the UK, US and India. Also, the need for global harmonisation and its practices is evaluated.

1.4 Research Objectives

The main objectives of this research are:

• To analyse the practice of regulating the side-effects of the drugs that are a licence for human use 

• To compare the pharmacovigilance regulation in the US, UK and India.

• To investigate the need for global harmonisation

• To evaluate the effects of global harmonisation

Research Question

The main research questions for this study are that why there is the need for international harmonisation, also what could happen to the data and how would it exactly impact public health? Another research question is how the Pharmacovigilance regulation is done in the US, UK and India? 

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