The UK based Symogen with expertise in all aspects of pharmacovigilance and pharmacoepidemiology will start a highly intensive and focused course on pharmacovigilance and pharmacoepidemiology from September 2007. The course titled as a certificate course in 'Pharmacovigilance and Pharmacoepidemiology'. This course is the first of its kind to be starting in the Indian context.
Talking to Pharmabiz, Dr Pipasha Biswas, pharmaceutical medicine physician and consultant of Symogen, said, "We are offering four month certification course on Pharmacovigilance which will be held twice a year for four months each. The course fees is different for the Indian and overseas students. We are charging Rs 85,000 for the Indian student and US $ 5,000 for the overseas students. The each batch is having 30 seats. We are conducting 30 minutes telephonic interview and selected candidates are only able to get admission for the course. The first batch intake will be from September 2007 to December 2007 based in New Delhi and from January 2008 to April 2008 in Mumbai. The same pattern will run every year. This course is also endorsed and supported by the WHO-Uppsala Monitoring Centre, Sweden."
The course is designed as 12 modules spread over four months to cover all aspects of Pharmacovigilance, regulatory requirements, safety standards and safety data management with special emphasis on certain topics as required for the Indian scenario. An eight-hour classroom session on 12 Saturday, during the duration of the course will be held to include discussions, presentations, case studies, hands-on experiences and queries. There will also be a four hours self-learning by completing an assignment on the topics covered in class.
Symogen sensitises the students and equips them with knowledge on Pharmacovigilance practices worldwide and on the Indian scenario in detail. This course gives young executives an opportunity to remain ahead of competitors in a very nascent yet competitive environment.
The course is designed for the doctors and physicians of all disciplines (both fresh graduates with at least one year of clinical experience working in hospitals and post graduates), post graduates in pharmacy and biosciences and junior professionals in Pharmaceutical and IT Industry, clinical research organizations, BPOs, academia and regulatory agencies. Candidates who complete the course will be awarded by the certification in "Pharmacovigilance and Pharmacoepidemiology" from the Symogen India.
Pharmacovigilance is still in its infancy in India. However, with more and more clinical research activities being conducted in India, there is an immense need to understand the importance of pharmacovigilance and how it impacts the life cycle of the product, so as to integrate good pharmacovigilance practices in the processes and procedures to help ensure regulatory compliance and enhance the quality of clinical trials safety and post marketing pharmacovigilance.