About the Program
Objectives of the Program
- To provide an overview of the role of Artificial Intelligence (AI) and Machine Learning (ML) in transforming pharmacovigilance and pharmaceutical regulatory affairs.
- To discuss the application of AI-enabled technologies in adverse drug reaction (ADR) detection, signal management, risk assessment, and post-marketing surveillance.
- To enhance participants' understanding of current national and international regulatory frameworks governing AI-enabled healthcare technologies, pharmaceuticals, and pharmacovigilance systems.
- To explore the integration of AI in regulatory submissions, regulatory intelligence, document management, compliance monitoring, and decision-making.
Expected outcomes of the Program
- Participants will gain a comprehensive understanding of the role of Artificial Intelligence (AI) and Machine Learning (ML) in modern pharmacovigilance and pharmaceutical regulatory affairs.
- Participants will be able to explain the application of AI in adverse drug reaction (ADR) detection, signal management, risk assessment, and post-marketing surveillance to improve drug safety.
- Participants will develop an understanding of national and international regulatory frameworks governing AI-enabled healthcare technologies, pharmaceuticals, and pharmacovigilance systems.
- Participants will acquire knowledge of AI-driven regulatory processes, including regulatory submissions, regulatory intelligence, document management, compliance monitoring, and data-driven decision-making
Committee Members
- Dr. Manjunatha PM, Professor & Principal, ABMRCP
- Dr. Shivanand K Mutta
- Mr. Russell Martin
- Mr. Shaik Azeem Ahmed
Resource Persons
Mr. Gurumuthaiah
Designation: Senior Manager
Indegene Ltd Bangalore
Ms. Sushma Hegde
Designation: Anthem Bioscience
Mr. Manjunath R
Designation: Sr. Manager
Regulatory Affairs, Relonchem Ltd.