Clinical Research and Pharmacovigilance detailed syllabus for Pharmacy (Pharma) for 2021 regulation curriculum has been taken from the Anna Universities official website and presented for the Pharma students. For course code, course name, number of credits for a course and other scheme related information, do visit full semester subjects post given below.
For Pharmacy 5th Sem scheme and its subjects, do visit Pharma 5th Sem 2021 regulation scheme. For Professional Elective-I scheme and its subjects refer to Pharma Professional Elective-I syllabus scheme. The detailed syllabus of clinical research and pharmacovigilance is as follows.
Course Objectives:
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Unit I
REGULATORY PERSPECTIVES OF CLINICAL TRIALS 9
Origin and Principles of International Conference on Harmonization – Good Clinical Practice (ICH-GCP) guidelines; Ethical Committee: Institutional Review Board, Ethical Guidelines for Biomedical Research and Human Participant-Schedule Y, ICMR, the Informed Consent Process: Structure and content of an Informed Consent Process, Ethical principles governing informed consent process.
Unit II
CLINICAL TRIALS- TYPES AND DESIGN 9
Experimental Study- Randomised Clinical Trials and Non Randomised Clinical Trials, Observation Study: Cohort, Case Control, Cross sectional; Roles and responsibilities of Clinical Trial Personnel: Investigator, Study Coordinator, Sponsor, Contract Research Organization and its management.
Unit III
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Unit IV
BASIC ASPECTS/TERMINOLOGIES OF PHARMACOVIGILANCE 9
History and progress of pharmacovigilance, Significance of safety monitoring, Pharmacovigilance in India and international aspects, WHO international drug monitoring programme, WHO and Regulatory terminologies of Adverse Drug Reactions, evaluation of medication safety, Establishing pharmacovigilance centres in Hospitals, Industry and National programmes related to pharmacovigilance.
Unit V
METHODS, ADR REPORTING, TOOLS FOR PHARMACOVIGILANCE 9
International classification of diseases, International Non-proprietary names for drugs, Passive and Active surveillance, Comparative observational studies, targeted clinical investigations and Vaccine safety surveillance. Spontaneous reporting system and Reporting to regulatory authorities, Guidelines for ADRs reporting. Argus, Aris G Pharmacovigilance, VigiFlow, Statistical methods for evaluating medication safety Data.
Course Outcomes:
At the end of the course the students will be able to,
- apply the knowledge of the regulatory requirements for conducting clinical trials.
- apply the knowledge of different clinical trial designs in conducting clinical trials.
- explain the responsibilities of key players involved in clinical trials and execute safety monitoring, reporting, close-out activities etc.
- elucidate the principles of pharmacovigilance and detect new adverse drug reactions and their assessment.
- comprehend the various pharmacovigilance methods and reporting systems.
- analyze and compare the data generated during clinical research and pharmacovigilance study.
Text Books:
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Reference Books:
- Clinical Data Management edited by R K Rondels, S A Varley, C F Webbs. Second Edition, Jan 2000, Wiley Publications.
- Handbook of Clinical Research. Julia Lloyd and Ann Raven Ed.,1994 Churchill Livingstone.
- Principles of Clinical Research edited by Giovanna di Ignazio, Di Giovanna and Haynes,2001
- Blaisdell, Peter, “Twenty – First Century Pharmaceutical Development”, Interpharm Press, 2001.
- Gad, Shayne C. “Drug Safety Evaluation”, John – Wiley & Sons, 2016.
For detailed syllabus of all the other subjects of Pharmacy 5th Sem, visit Pharma 5th Sem subject syllabuses for 2021 regulation.
For all Pharmacy results, visit Anna University Pharma all semester results direct link.