PM5002: Clinical Research and Pharmacovigilance Syllabus for Pharma Tech 5th Sem 2019 Regulation Anna University (Professional Elective-II)

Clinical Research and Pharmacovigilance detailed syllabus for Pharmaceutical Technology (Pharma Tech) for 2019 regulation curriculum has been taken from the Anna Universities official website and presented for the Pharma Tech 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 Pharmaceutical Technology 5th Sem scheme and its subjects, do visit Pharma Tech 5th Sem 2019 regulation scheme. For Professional Elective-II scheme and its subjects refer to Pharma Tech Professional Elective-II syllabus scheme. The detailed syllabus of clinical research and pharmacovigilance is as follows.

Course Objective:

For the complete syllabus, results, class timetable, and many other features kindly download the iStudy App
It is a lightweight, easy to use, no images, and no pdfs platform to make students’s lives easier.
.

Unit I

Regulatory Perspectives of Clinical Trials
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

For the complete syllabus, results, class timetable, and many other features kindly download the iStudy App
It is a lightweight, easy to use, no images, and no pdfs platform to make students’s lives easier.
.

Unit III

Clinical Trial Documentation
Guidelines to the preparation of documents, Preparation of protocol, Investigator Brochure, Case Report Forms, Clinical Study Report Clinical Trial Monitoring-Safety Monitoring in CT Adverse Drug Reactions: Definition and types. Detection and reporting methods.Severity and seriousness assessment.predictability and preventability assessment. Management of adverse drug reactions; Terminologies of ADR.

Unit IV

For the complete syllabus, results, class timetable, and many other features kindly download the iStudy App
It is a lightweight, easy to use, no images, and no pdfs platform to make students’s lives easier.
.

Unit V

Methods, Adr Reporting, Tools for Pharmacovigilance
International classification of diseases, International Nonproprietary 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 Outcome:

For the complete syllabus, results, class timetable, and many other features kindly download the iStudy App
It is a lightweight, easy to use, no images, and no pdfs platform to make students’s lives easier.
.

Text Books:

1. Textbook of Clinical Trials edited by David Machin, Simon Day and Sylvan Green, March 2005, John Wiley and Sons.
2. A textbook of Clinical Pharmacy Practice: Essential Concepts and Skills. Second Edition, 2012, University Press
3. Central Drugs Standard Control Organization- Good Clinical Practices, Guidelines for Clinical Trials on Pharmaceutical Products in India. New Delhi: Ministry of Health; 2001.
4. International Conference on Harmonization of Technical requirements for registration of Pharmaceuticals for human use. ICH Harmonized Tripartite Guideline. Guideline for Good Clinical Practice. E6; May 1996.230
5. Ethical Guidelines for Biomedical Research on Human Subjects 2000. Indian Council of Medical Research, New Delhi.
6. Textbook of Pharmacovigilance: Concept and Practice. G. P. Mohanta and P. K. Manna. 2016, Pharma Med Press.

References:

1. Clinical Data Management edited by R K Rondels, S A Varley, C F Webbs. Second Edition, Jan 2000, Wiley Publications.
2. Handbook of clinical Research. Julia Lloyd and Ann Raven Ed. Churchill Livingstone.
3. Principles of Clinical Research edited by Giovanna di Ignazio, Di Giovanna and Haynes.
4. Blaisdell, Peter, “Twenty – First Century Pharmaceutical Development”, Interpharm Press, 2001.
5. Gad, Shayne C. “Drug Safety Evaluation”, John – Wiley and Sons, 2002.

For detailed syllabus of all the other subjects of Pharmaceutical Technology 5th Sem, visit Pharma Tech 5th Sem subject syllabuses for 2019 regulation.

For all Pharmaceutical Technology results, visit Anna University Pharma Tech all semester results direct link.