PY8017 - PHARMACOVIGILANCE (Syllabus) 2017-regulation Anna University

PY8017 - PHARMACOVIGILANCE (Syllabus) 2017-regulation Anna University

PY8017	PHARMACOVIGILANCE	LPTC

3003

OBJECTIVES:

• The course intends to provide knowledge about development and global scenario of pharmacovigilance and establishment of pharmacovigilance programme in an organization
• To develops the skills of classifying drugs, diseases and adverse drug reactions.

UNIT I	INTRODUCTION TO PHARMACOVIGILANCE	9

Scope and development of Pharmacovigilance - Importance of safety monitoring of Medicine - WHO international drug monitoring programme - Pharmacovigilance Program of India (PvPI) - Definitions and classification of adverse drug reactions - Detection and reporting - Methods in Causality assessment - Severity and seriousness assessment - Predictability and preventability assessment - Management of adverse drug reactions - Terminologies used in pharmacovigilance, adverse medication related events and Regulatory terminologies.

UNIT II	SOURCES OF DATA	9

Anatomical, therapeutic and chemical classification of drugs - International classification of diseases -Daily defined doses - International Nonproprietary Names for drugs - Drug dictionaries and coding in pharmacovigilance - WHO adverse reaction terminologies - MedDRA and StandardisedMedDRA queries - WHO drug dictionary - Eudravigilance medicinal product dictionary Information resources in pharmacovigilance - Basic drug information resources - Specialised resources for ADRs Establishing pharmacovigilance programme - Pre-clinical studies- Human volunteer studies - Clinical trials - Post-marketing surveillance - Systematic reviews and meta-analysis -

UNIT III	PHARMACOVIGILANCE METHODS	9

Pharmacovigilance methods - Passive surveillance – Spontaneous reports and case series - Stimulated reporting - Active surveillance – Sentinel sites, drug event monitoring and registries - Comparative observational studies – Cross sectional study, case control study and cohort study - Targeted clinical investigations. Communication in pharmacovigilance - Effective communication in Pharmacovigilance -Communication in Drug Safety Crisis management - Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media.

UNIT IV	STATISTICAL METHODS FOR EVALUATING MEDICATION SAFETY DATA	9

Safety data generation - Pre clinical phase - Clinical phase - Post approval phase. ICH Guidelines for Pharmacovigilance - Organization and objectives of ICH - Expedited reporting - Individual case safety reports - Periodic safety update reports - Post approval expedited reporting - Pharmacovigilance planning - Good clinical practice in pharmacovigilance studies.

UNIT V	PHARMACOGENOMICS OF ADVERSE DRUG REACTIONS	9

Drug safety evaluation in special population - Pediatrics - Pregnancy and lactation – Geriatrics. CIOMS - CIOMS Working Groups - CIOMS Form. CDSCO (India) and Pharmacovigilance - D&C Act and Schedule Y - Differences in Indian and global pharmacovigilance requirements

TOTAL : 45 PERIODS

OUTCOMES: At the completion of course, the student will be able

• To report adverse drug reaction in proper format.
• To analyze and compare the data generated during pharmacovigilance study
• To manage and adhere with regulatory requirements of different country.

TEXT BOOKS:

1. SumitVerma, S and Gulati, Y. Fundamentals of Pharmacovigilance, Paras Medical Publishers, 2017
2. Gupta, S. K. Text book of Pharmacovigilance, Jaypee Brothers Medical Publishers, 2011.
3. Mohanta, G.P and Manna, P.K. A Textbook of Pharmacovigilance: Concept and Practice, PharmaMed Press, 2015.

REFERENCES:

1. Andrews, E.B and Moore, N. Mann's Pharmacovigilance, Wiley-Blackwel, 3rd Edition, 2014.
2. Waller, P and Harrison‐Woolrych, M. An Introduction to Pharmacovigilance, Wiley- Blackwel, 2nd Edition, 2017
3. Orleans-Lindsay, J. Pharmacovigilance Medical Writing: A Good Practice Guide, Wiley- Blackwell, 2012.