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clinical research course

CLINICAL RESEARCH COURSE

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.

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

MedDRA

ICH Guidelines