PMKVY 4.0 RPL Upskilling by Life Sciences Sector Skill Development Council

SKILL DEVELOPMENT PROGRAMME- PHARMACOVIGILANCE CASE

PROCESSING – 21st JAN 2025- 25th JAN 2025

TRAINER: DR. SHOBHA RANI R HIREMATH

INAUGURATION OF PMKVY 4.0 RPL/WITH LSSSDC

The PMKVY 4.0 Recognition of Prior Learning (RPL)/Upskilling Programme, organized by the Life Sciences Sector Skill Development Council (LSSSDC), was successfully inaugurated on 21st January 2025 at Aditya Bangalore Institute of Pharmacy Education andResearch. The program, “Pharmacovigilance – Case Processing”, spanning 30 hours, aimsto enhance skills in Pharmacovigilance (PV) and was inaugurated in the presence of eminent dignitaries. The event was graced by Dr. Sirse Kranti Kumar, Registrar of the Karnataka State .Pharmacy Council (KSPC), and Dr. Salma Khanam, Coordinator of the KSPC Skill Development Center. Dr. Salma Khanam, provided an insightful introduction to the Pradhan Mantri Kaushal Vikas Yojana (PMKVY), Recognition of Prior Learning (RPL), and the roleof LSSSDC in driving skill development initiatives in the life sciences sector. Dr. Sirse Kranti Kumar highlighted the key role of KSPC in advancing pharmacy education and supporting initiatives that enhance professional competence and patient safety. Both dignitaries emphasized the importance of such programs in strengthening pharmacy practice. The session trainer, Dr. Shobha Rani R. H., a distinguished expert in pharmacovigilance,delivered an engaging and informative lecture on Day 1, setting the tone for the program.The opening session focused on Pharmacovigilance, offering participants insights into its significance in healthcare. Key topics included the historical perspective of PV, with an emphasis on the Thalidomide tragedy, and the role of the Uppsala Monitoring Centre (UMC) in global ADR monitoring. Concepts such as the definition and classification of Adverse Drug Reactions (ADRs), causality assessment, spontaneous reporting, and ADR management were thoroughly discussed. Participants also explored diverse data sources for ADR identification, such as clinical trials, electronic health records, and social media platforms.

DAY 2- DOMAIN TRAINING

Day 2 of the PMKVY 4.0 RPL/ Upskilling program by LSSSDC, was led by Dr. Shobha Rani. She provided an overview of its role in identifying, assessing, and preventing adverse drug reactions (ADRs), emphasizing robust case processing for patient safety and regulatory compliance. The session detailed key steps in case processing: case receipt, triage based on severity, data entry into pharmacovigilance databases, and medical assessment for causality and seriousness. Dr. Shobha Rani also highlighted regulatory reporting requirements to agencies like the EMA and FDA, stressing regional differences and the need for timely compliance. The session concluded with an engaging Q&A, enhancing participants’ understanding of ADR case handling and global pharmacovigilance standards.

DAY 3- DOMAIN KNOWLEDGE FOR THE JOB ROLE

The PMKVY 4.0 Recognition of Prior Learning (RPL)/Upskilling Programme, organized by the Life Sciences Sector Skill Development Council (LSSSDC), Day-3 Dr. Shobha Rani R. led a session on the transformative role of AI-driven technologies and Natural Language Processing (NLP) in pharmacovigilance. Dr. Shobha Rani, discussed AI-driven signal detection for identifying and prioritizing safety risks from large datasets and highlighted NLP’s ability to extract insights from unstructured data, such as patient narratives, to enhance case documentation and assessments. The session also addressed the integration of these technologies into regulatory reporting to improve accuracy, reduce processing times, and ensure compliance.

DAY 4- FAMILIARIZATION TO THE ASSESSMENT PROCESS AND TERMS

The PMKVY 4.0 RPL/Upskilling Program by LSSSDC, Day 4- led by Dr. Shobha Rani R H, focused on key pharmacovigilance (PV) topics. The session began with signal detection, covering qualitative methods like expert review and quantitative approaches such as data mining. Dr. Shobha Rani then explained global regulatory frameworks, including EMA and FDA requirements, followed by the importance of data quality assurance in ensuring reliable safety monitoring.The session highlighted case processing quality assurance, emphasizing accuracy in data entry, causality assessment, and compliance with timelines. Participants also learned about the case validation process and standards for ensuring consistency and completeness in PV cases. The discussion on regulatory reporting and compliance covered timelines and requirements for submitting safety data to authorities. The day concluded with a pharmacovigilance case study, giving participants hands-on experience in applying PV concepts. The session provided a clear understanding of PV practices, enhancing participants’ skills in regulatory compliance and drug safety monitoring.

DAY 5- ABOUT ASSESSMENT

The fifth and final day of the PMKVY 4.0 RPL/Upskilling program focused on assessment, which included a Theory exam, Practical exam, and Viva. Conducted by Mr. Venkataramana Aigal, the assessments aimed to evaluate participants’ theoretical knowledge, practical skills, and overall understanding. The day began with the Theory exam, followed by the Practical exam where participants demonstrated their hands-on skills. The Viva sessions, conducted one-on-one, assessed their ability to explain concepts and solve problems. Mr. Venkataramana Aigal ensured a fair and smooth assessment process, engaging with each participant thoughtfully. Overall, participants performed well, showcasing a strong grasp of both theory and practice. Feedback highlighted their satisfaction with the training and the assessment process. Mr. Aigal’s clear guidance and supportive approach contributed to the successful conclusion of tthe program