Industrial Diploma in Clinical Research & Pharmacovigilance

Program details: the objective of this program is to provide complete understanding of the clinical research and pharmacovigilance process and to provide working knowledge to the students which would enable them to work in the industry with minimal training. In the first phase we would provide a comprehensive knowledge to the clinical research processes, roles and responsibilities, ethics, monitoring, conduct and management of trials and various other related issues. In the second phase extensive training on pharmacovigilance (pv) is provided. Pv 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. The program would cover:

• mode: distance learning & online
• duration: six months
• eligibility : md, ms, mbbs, bhms, bds, bams, bums, graduate/post graduate degree in science,
• pharmacy, medical laboratory, nursing, biochemistry, microbiology, biotechnology and all professionals working with pharmaceutical companies or cros
• methodology: printed training modules, cd/dvd, ebooks, powerpoint, workshops, assignments,
• examination: online mcqs, assignment & exercises.
• Certificate: certificate would be awarded at the end of the program.
• Job assistance: placement support would be provided to the successful candidates.

idcrp® modules

clinical research

• module 1: introduction to clinical trials and historical aspects

• module 2: ich-good clinical practice (gcp) guidelines and schedule y

• module 3: ethics in clinical research

• module 4: fundamental of clinical trial design

• module 5: designing of clinical study documents (case record form, inform consent)

• module 6: protocol designing for conducting clinical trials

• module 7: clinical trial application requirement

• module 8: requirements for permission of new drugs approval in india

• module 9: overview of regulatory requirements in india, us, europe

• module 10: ind/anda/new drug application

pharmacovigilance

• module 11: basic principles of pharmacovigilance: definitions and historical aspects
• module 12a: who programme – global monitoring (medwatch)
• module 12b: national pharmacovigilance program (npp), india
• module 13: management of pharmacovigilance data
• module 14: spontaneous case processing and literature searching
• module 15: periodic safety update reports (psur)
• module 16: evaluation of safety data and risk management plan
• module 17: medical dictionary for regulatory activities (meddra®)
• module 18: data mining in pharmacovigilance
• module 19a: identifying & describing safety signals
• module 19b: statistical methods of evaluating pharmacovigilance data
• module 20: guidelines for setting up and running pharmacovigilance centre

1. kcs pharma

academy of clinical research & pharmacovigilance

1. kcs pharma

academy of clinical research & pharmacovigilance