Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
The main goal of pharmacovigilance is thus to promote the safe and effective use of health products, in particular by providing timely information about the safety of health products to patients, health-care professionals, and the public.
Basic level of English and good quality of internet connection,Desktop/Laptop/Smartphone required
Basic Knowledge on Pharmaceutical/ medical field.
Graduates in Pharmacy and Bio -Sciences, Medical Professionals, i.e Doctors of all disciplines, junior
professionals in Pharmaceutical and IT Industry, Clinical Research professionals.D.Pharmacy,
B.Pharmacy, M.Pharmacy, MBBS, BDS, BAMS ..etc
Course Study Materials
Unit 1 Basic Concepts of Pharmacovigilance (Part-A)
1.1 Introduction to Pharmocovigilance
1.2 Introduction to Adverse Drug Reactions
1.3 Basic Terminologies Used in Pharmocovigilance
Basic Concepts of Pharmacovigilance (Part-A) Assessment5 Questions
Unit 2 Basic Concepts of Pharmacovigilance (Part-B)
2.1 Drug and Disease Classification
2.2 Drug Dictionaries and Coding in Pharmacovigilance
2.3 Information Resources in Pharmacovigilance
2.4 Establishing Pharmacovigilance Programme
Basic Concepts of Pharmacovigilance (Part-B) Assessment5 Questions
Unit 3 Vaccine Safety, Methods and Communication in Pharmacovigilance
3.1 Vaccine Safety Surveillance
3.2 Pharmacovigilance Methods
3.3 Communication in Pharmacovigilance
Vaccine Safety, Methods and Communication in Pharmacovigilance Assessment5 Questions
Unit 4 Safety Data Generation And ICH Guidelines
4.1 Statistical Methods for Evaluating Medication Safety Data
4.2 Safety Data Generation
4.3 ICH Guidelines for Pharmacovigilance
Safety Data Generation And ICH Guidelines Assessment5 Questions
UNIT 5 PHARMACOGENOMICS, CIOMS AND CDSCO
5.1 Pharmacogenomics of Adverse Drug Reactions
5.4 CDSCO (INDIA) and Pharmacovigilance
PHARMACOGENOMICS, CIOMS AND CDSCO Assessment5 Questions
Final Assessment20 Questions
The certificate issued for the Course will have
Date of Course Completion
Name(s) and Logo(s) of the Certifying Bodies
Only the e-certificate will be made available. No Hard copies. The certificates issued by The Academic Council of uLektz. can be e-verifiable at www.ulektzskills.com/verify.
Students will be assessed both at the end of each module and at the end of the Course.
Students scoring a minimum of 50% in the assessments are considered for Certifications