Professional Excellence Program in Pharmacovigilance (PEP-PV)

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Course overview

The courses have been prepared keeping in mind the current Clinical Research industry requirements so that the deserving candidates can imbibe all the desired concepts of the Clinical Research, Clinical Data Management, Medical Writing and Clinical Operations. In this type of online environment, a student gets more time to assimilate a concept due to self-paced delivery, reception of the required learning materials under the guidance of experienced trainers. Also, we have internal chats and forums during online sessions which are very efficient to enhance student's learning and interaction.

What will i learn?

Clinical Research Coordinator role
Clinical Research Associate role

Requirements

B.Pharm, M.Pharm and Pharm.D
B.Sc. M.Sc and Ph.D (Biotechnology, Microbiology, Biochemistry and Nursing etc)
BPT, MPT, BDS, BAMS, BHMS and MBBS
B.E., B.Tech. M.Tech (Biotech/ Biomedical Engineering)

Curriculum for this course

40 Lessons 21:07:01 Hours

Introduction to Pharmacovigilance

3 Lessons 01:23:07 Hours

History and Development of Pharmacovigilance and Importance of Safety Monitoring
00:28:48
WHO International Drug Monitoring Program
00:24:18
Pharmacovigilance Program of India
00:30:01

Introduction to adverse drug reactions

3 Lessons 01:31:10 Hours

Definition and Classification of ADR
00:32:06
Detection and Reporting Methods and Management of Adverse Drug Reactions
00:26:18
Methods in Causality Assessment, Severity and Seriousness assessment, Predictability and Preventability assessment
00:32:46

Basic terminologies used in pharmacovigilance

1 Lessons 00:40:41 Hours

Terminologies of Adverse Medication Related Events and Regulatory Terminologies
00:40:41

Drug and disease classification

3 Lessons 01:31:48 Hours

Anatomical, therapeutic and chemical classification of drugs
00:34:48
Daily Defined Doses
00:37:25
International Non-Proprietary Names for Drugs
00:19:35

Drug dictionaries and coding in pharmacovigilance

2 Lessons 01:08:01 Hours

MedDRA and Standardised MedDRA queries
00:35:11
WHO Drug Dictionary
00:32:50

Information resources in pharmacovigilance

2 Lessons 00:53:24 Hours

Basic drug information resources
00:27:47
Specialised resources for ADRs
00:25:37

Establishing pharmacovigilance programme

4 Lessons 01:51:35 Hours

Establishing in a hospital
00:26:19
Establishment & operation of drug safety department in industry
00:25:57
Contract Research Organisations (CROs)
00:34:23
Establishing a national programme
00:24:56

Vaccine safety surveillance

2 Lessons 01:21:22 Hours

Vaccine Pharmacovigilance
00:38:45
AEFI (Adverse event following Immunization) and types of AEFI
00:42:37

Pharmacovigilance methods

3 Lessons 01:29:42 Hours

Passive Surveillance
00:31:47
Active Surveillance
00:29:09
Comparative Observational Studies & Targeted Clinical Investigation
00:28:46

Communication in pharmacovigilance

2 Lessons 00:41:31 Hours

Effective Communication in Pharmacovigilance (Part-1)
00:15:51
Communication in Drug Safety Crisis Management
00:25:40

Safety data generation

2 Lessons 01:19:13 Hours

Safety Data Generation In Preclinical Phase
00:40:50
Safety Data Generation In Clinical & Post Approval Phase
00:38:23

ICH Guidelines for Pharmacovigilance

6 Lessons 03:24:45 Hours

Organization And Objectives of ICH
00:38:17
Expedited Reporting And Post Approval Expedited Reporting
00:26:05
ICSR(Individual Case Safety Report)
00:29:22
PSUR (Periodic Safety Update Report)
00:38:59
Pharmacovigilance Planning
00:37:17
Good Clinical Practices In Pharmacovigilance Studies
00:34:45

Pharmacogenomics of adverse drug reactions

1 Lessons 00:33:21 Hours

Genetics related ADR with example focusing PK parameters
00:33:21

Drug safety evaluation in special population

3 Lessons 01:38:22 Hours

Drug safety evaluation in Paediatrics
00:33:15
Drug safety evaluation in Pregnancy & lactation
00:32:48
Drug Safety Evaluation in Geriatrics
00:32:19

CIOMS

1 Lessons 00:29:06 Hours

CIOMS Working Groups & Form
00:29:06

CDSCO (India) and Pharmacovigilance

2 Lessons 01:09:53 Hours

D & C Act and Schedule Y
00:30:08
Differences in Indian and global pharmacovigilance requirements
00:39:45

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About instructor

Team Cliniversity

2 Reviews | 12 Students | 3 Courses

Student feedback

2 Reviews

Reviews

Anuj Kumar Tripathi

Best self study trainings.
Sreeraj T

This course in pharmacovigilance was well-structured and informative. The content was up-to-date and covered all the important aspects of pharmacovigilance. The lectures were clear and engaging. The course was also self-paced, allowing me to complete it at my own convenience. I would definitely recommend this course to anyone interested in the field of pharmacovigilance.

Professional Excellence Program in Pharmacovigilance (PEP-PV)

What will i learn?

Team Cliniversity

Reviews

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