uLektz Academy

Learning Path

Non-Linear: Random Order

About the Course

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.

Requirements

Basic level of English and good quality of internet connection,Desktop/Laptop/Smartphone required
Basic Knowledge on Pharmaceutical/ medical field.

Eligibility

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) Assessment 5 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) Assessment 5 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 Assessment 5 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 Assessment 5 Questions

UNIT 5 PHARMACOGENOMICS, CIOMS AND CDSCO

5.1 Pharmacogenomics of Adverse Drug Reactions
5.2 CIOMS
5.3 CDSCO (INDIA) and Pharmacovigilance
PHARMACOGENOMICS, CIOMS AND CDSCO Assessment 5 Questions

Final Assessment

Final Assessment 20 Questions

The certificate issued for the Course will have the student's Name, Photograph, Course Title, Certificate number, Date of course completion and the name(s) and logo(s) of the Certifying Bodies. Only the e-certificate will be made available. No Hard copies. The certificates issued by uLektz Learning Solutions Pvt. Ltd. can be e-verifiable at www.ulektzskills.com/verify.

Students are required to take online assessments with eProctoring.
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