Clinical Research, Course In Pharmacovigilance

1. Monitoring the safety of medicines in clinical use is essential for preventing the patients. Hence, it is necessary to have a well-organized Pharmacovigilance system. This article summarizes the need of Pharmacovigilance and available courses in Pharmacovigilance. Course in Pharmacovigilance – Ensuring the Safe Use of Medicines

2. Aim of Pharmacovigilance Pharmacovigilance is the set of activities relating to the detection and understanding of adverse effects and other drug related problems. The objective of Pharmacovigilance is to increase patient attention and care in relation to the use of medicines. It also aims at providing consistent and stabilised information to support public health programmes. Course in Pharmacovigilance aims for • Improve safety of patients in relation to the use of the drug. • Medical and paramedical intervention • Contribute to the assessment of effectiveness of medicines • Promotes understanding and education in Pharmacovigilance • Effective communication to public and health professional.

3. Need of Pharmacovigilance A medicine is legally set free for consumption by the general population after it is released into the market. There is commercial pressure for the pharmaceutical industry to find the drugs that are marketed globally to maximise profit in the shortest possible time. Because of that pre-marketing safety issues may be unnoticed and some medicines will only have been tested for short-term safety on a limited number of selected individuals. Therefore, it is essential that still progressing treatments are monitored for their effectiveness and more information are needed about using of medicines in specific population groups and combinations with other medicines. The Pharmacovigilance is essential for some of the other reasons, they are • Insufficient evidence of safety in clinical trials prior to marketing • Patients dying from medicines • Adverse drug reactions are expensive. • To Protect patients from unnecessary harm • To promote rational use of medicines • To ensure public confidence

4. Pharmacovigilance course Pharmacovigilance is an integral part of clinical research. It refers to the assessment and prevention of adverse drug reaction and needs to ensure the safety of human beings. Candidates can pursue both certificate and diploma courses in the field of pharmacovigilance. The course in Pharmacovigilance is designed to impart the knowledge of regulatory requirement of drug safety. Some of the Pharmacovigilance course are, • Diploma in Pharmacovigilance: This course has been structured by the experts and provides an understanding of the industry and its functional areas. It explains the participant with the updated theoretical knowledge and practical aspects of Pharmacovigilance. The diploma course in Pharmacovigilance provides better industrial training and skills, better knowledge of the industry and professional training about the industry regulations for the candidates. • Diploma in Clinical research and Pharmacovigilance: This is an integrated course that provides the candidates with a systematic understanding of the clinical research process and Pharmacovigilance methods. It helps the candidate to analyse and achieve the drug reaction data for making regulatory decisions regarding marketed drugs. • Diploma in Pharmacovigilance and regulatory affairs: This course in Pharmacovigilance is practically focused and the candidates are highly driven by Pharmacovigilance and regulatory affairs program. They are prepared with the knowledge of the global regulatory view and they develop skills necessary for regulatory strategic planning.

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