Clinical Research & PharmacovigilancePG Diploma in Clinical ResearchPharmacovigilance

New EU Directives and the importance of Pharmacovigilance Training in India

On the 26th of June 2013, the European Commission has adopted a proposal for regulation for the Conduct of Pharmacovigilance Activities in Respect of Medicinal Products for Human use. These changes in legislation will have an impact on the way assessment of drugs are carried out in both the stages of pre and post authorization, introduce new obligations to Marketing Authorization holders, and bring a continuous risk/ benefit assessment of drugs. The directives have implied that there should be extensive Pharmacovigilance inspections conducted by competent authorities and sanctions should be implied on companies and on individuals if necessary. Not to be forgotten about the large number of deaths that occur every year, all over the world due to ADRs. Owing to all the above, it is evident that pharmaceutical companies all over the world have to adapt and implement to the new EU Pharmacovigilance Regulations and Directives and to Good Pharmacovigilance Practice Modules.

While in the western world there had been a significant amount of stress for the development of Pharmacovigilance Training, the same cannot be said about India. The need of the hour right now is effective training to professionals as well potential students as India is attracting a major chunk of outsourced work in Pharmacovigilance and many software companies are increasingly showing their interest to invest in this particular field of business.

To deliver and to maintain work of international standards, it is the need of the hour to develop and implement a robust curriculum in Pharmacovigilance, which encompasses every module of Pharmacovigilance. For many content developers and academic experts, this might come up as a huge challenge, as Pharmacovigilance has a range of subjects to be deal with like Epidemiology, Pharmacology, Clinical Data Management etc. The candidate also needs to be proficient in using computers as well as most companies rely on specific web based tools to run Pharmacovigilance work on a day to day basis. The curriculum should target students and professionals alike and cater to their needs. For example, when training physicians, it is important more importance should be given upon reporting ADRs. For final year medical students, a separate project work on Pharmacovigilance  can be encouraged, which they can submit during their final year of dissertation. Periodic seminars and conferences should be conducted by pharmaceutical companies, inviting professionals and students from the healthcare industry, making them aware of the latest norms and nuances in Pharmacovigilance.

With the advent of technology, there are various online courses available on the internet, which can be taken up and completed on time by the student at his/her own pace. This branch of science has great opportunities; it opens up new windows for jobs and career growth. But most importantly, it ensures that the risk to patients suffering from ADRs is minimized, thus saving costs to healthcare systems. It is high time that our government wakes up to the need of importance of Pharmacovigilance Training in the country.

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