?

The Pradhan Mantri Kaushal Vikas Yojana (PMKVY) 4.0 Recognized Prior Learning (RPL) Scheme in Pharmacovigilance was a five-day training and assessment program conducted by the Karnataka State Pharmacy Council (KSPC) in collaboration with LSSSDC under the PMKVY 4.0 initiative. The training was conducted by Dr. Mohammed Salim KT (Assistant Professor, Senior Scale, Department of Pharmacy Practice, MCOPS) from February 17th to 20th, 2025, followed by an assessment on February 22nd, 2025, which was performed by Mr. Venkataraman assigned from Team IRIS-Corp.

The training program was formally inaugurated on 17 February 2025, by the Chief Guest Dr. Saleemulla Khan, Central Council Member of the Pharmacy Council of India (PCI). The event was graced by the presence of Dr. Srinivas Mutalik, Principal, MCOPS, Dr. Usha Y Nayak, Vice Principal, MCOPS, and other distinguished faculty members. The inauguration emphasized the crucial role of pharmacovigilance in ensuring drug safety and strengthening healthcare practices. With 21 participants from Kerala, Karnataka, and other states in India, the program attracted a diverse group of pharmacy professionals committed to advancing their expertise in drug safety monitoring.

The four-day training provided a blend of theoretical learning and hands-on experience to equip participants with the necessary skills in pharmacovigilance. The first day began with an orientation session where participants were introduced to the fundamentals of pharmacovigilance, the role of AI in drug safety, and the responsibilities of regulatory agencies, healthcare professionals, and pharmaceutical companies. The session also included interactive discussions on ethical aspects of adverse event reporting and privacy concerns.

On the second day, the training focused on adverse event identification and case processing. Participants learned to classify adverse events into serious and non-serious categories, understand different data sources such as clinical trials and electronic health records, and explore various reporting methods. A practical session using Google Forms allowed participants to simulate adverse event case processing, reinforcing their understanding through real-time application.

The third day was dedicated to pharmacovigilance software tools and AI-driven drug safety monitoring. Participants received hands-on training on VigiFlow, a leading pharmacovigilance database, and explored how AI technologies such as machine learning, natural language processing (NLP), and predictive analytics enhance case management. The session also covered how AI can be used for signal detection, risk assessment, and automation of case processing, providing participants with insights into the evolving landscape of pharmacovigilance technology.

On the fourth day, the focus shifted to signal detection, risk management, and regulatory compliance. Participants explored various signal detection methodologies, risk assessment strategies, and regulatory frameworks, including those of the FDA, EMA, CDSCO, and PvPI-IPC. The session also provided insights into preparing for audits and regulatory inspections, which are essential for ensuring compliance in pharmacovigilance. The day concluded with real-world case studies and group activities, where participants analyzed adverse event reports, developed risk management plans, and engaged in regulatory reporting exercises.

The final day of the program was dedicated to a comprehensive assessment to evaluate the knowledge and practical skills acquired by participants during the training. Conducted by Mr. Venkataraman from Team IRIS-Corp, the assessment comprised three modules: a theory-based multiple-choice questionnaire (MCQ), an oral viva, and a practical examination.?