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10.3.11
Pharmacovigilance is a new discipline to the students of India which provides newer and better opportunities to aspirants across the country who wish to build their career in the field of pharmacological science.
Pharmacovigilance is a discipline which is concerned with identifying, validating, quantifying, evaluating and minimizing the adverse effects of medicine thereby increasing the safety of drugs in use. It is a study of drug related adverse effect carried out by pharmaceutical industries to suggest warnings and recommendation for product withdrawal.
Pharmacovigilance is not only an academic necessity but also a need to ensure security of human beings. It is an accepted opinion of the mass to scrutinize the adverse effects of medicines which have been released in the market.
The Government also puts forward a supportive hand and takes immediate actions for the implementation of such a course so that people become aware of the adverse effects of drugs which can be reduced by a discipline like pharmacovigilance.
Pharmacovigilance is important to implement quality systems in all pharmaceutical companies which produce huge amount of medicines that are marketed in India and Western Countries.
Courses
An aspirant of pharmacovigilance can pursue both certificate and diploma courses in pharmacovigilance.
The certificate course for Pharmacovigilance and Pharmacoepidemiology is for 4 months. The course is conducted by CLINI INDIA. The course fee is Rs.50,000 - Rs.80,000.
The two courses are taught by expert international faculty and well known national faculty who have several years of pharmacovigilance experience in practical and theoretical field.
To participate in these programmes of Pharmacovigilance, the eligibilities are:
Graduates in Pharmacy and Bio-Sciences, Medical Professionals, i.e Doctors of all disciplines, graduates in pharmacy and bio-sciences and junior professionals in Pharmaceutical and IT Industry, Clinical Research Organization are eligible for the course.
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Clinical Data Management
PCCRCDM (Professional Certificate In Clinical Research And Clinical Data Management)
Course Content:
Clinical Trial Process
Clinical Trial Design
Ethics & Good Clinical Practice
Clinical Data Management
CRF Design
Data Entry
Data Collection
Data Load
Data Storage
Data Validation
Query Management
Data Archiving
Quality Systems, Sops & Audits
Regulatory Affairs & Compliance
Safety Management and Pharmacovigilance
Statistical Analysis & Reporting
Data Management Systems & Tools
CDMS
AERS
EDC
Analytical Tools
Documentation & Document Management System
Medical coding and medical dictionaries
Project Management
Security systems
Practical:
Clinical Data Management System
Study Set-Up
Database Creation
CRF Creation
Data Entry
Data Validations
Query Management
Database lock
Statistical Software