To learn the applicable clinical research guidelines, personnel & stakeholders responsibilities, clinical trial study processes, Clinical Data management, Pharmacovigilance etc.
Advanced Post Graduate Diploma in Pharmacovigilance and Clinical Data management
Designed primarily for students of pharmacy, clinical research and allied health professions, Introduction to Statistics in Pharmaceutical Clinical Trials will also be invaluable to professionals entering the pharmaceutical, biotechnology and contract research organization industries who wish to gain a broader understanding of study design, data validation, data entry system tools, data programming and e-learning software.
Pharmacovigilance is critical to ensure the continued safety of drugs, as information on potential harms of a drug is incomplete when the drug is launched. Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines. Pharmacovigilance begins at the clinical stage and continues throughout the life cycle of the drug, mainly divided as pharmacovigilance during the clinical phase and post marketing. The process of collection of such information about a drug begins in phase I of the clinical trial, before approval of the drug, and continues even after approval; several post-market safety studies are conducted, with many made mandatory by drug regulatory agencies around the world.
We have divided the course in three modules. In First module, we cover the basic aspects of Clinical Data Management. In the second module, we cover core CDM knowledge like data validation and data development. In the third modules, we cover Pharmacovigilance knowledge like the regulations, signal detection, risk benefit analysis, medical dictionaries,
• To provide a comprehensive introduction to the Clinical Data Management process and Pharmacovigilance and Global Pharmacovigilance regulations.
• Learn the skills, knowledge and competencies of a candidate for the CDM.
• Practical aspects of important Pharmacovigilance activities as per the global standards like medical evaluation, casualty assessment, expectedness assessment, case narratives, MedDRA, case processing preparation of safety report etc
• Become more familiar with roles/jobs as part of the study team.
• Understanding of Databases , management of clinical data and Pharmacovigilance.
• Understanding of key enterprise clinical data management tools and Pharmacovigilance safety
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– Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc
– Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS etc
– Any degree in Pharmacy / Pharmaceutical Sciences
– Any degree in Chemistry / Biostatistics / Bioinformatics
– Any degree in Nursing / Allied Health.
– Students in their final year of graduation for the above courses are also eligible to apply.
If you lack the above mentioned educational prerequisite you may still be eligible to apply upon recommendation of your supervisor if you have some prior work experience in clinical research / pharmacovigilance / allied areas. Please contact our admission representatives / counsellor to discuss your case.
Length: 4 weeks
Timings: Self Paced
Effort: 55 hrs. approx
Skill Level: All