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Track 2 Session 2: Leveraging Technology in Clinical Research and Regulatory Affairs
Session Chair(s)
Manjusha Rajarshi
Founder Regulus Healthcare
Partner at roots-simplified Research and Consulting LLP, India
In this session, we will delve into the transformative impact of Artificial Intelligence (AI) on regulatory affairs, exploring how AI technologies are reshaping the landscape of compliance, risk management, and regulatory processes. As the regulatory environment becomes increasingly complex, the integration of AI offers Session 2: Leveraging Technology in Clinical Research and Regulatory Affairs Session Chair: Manjusha Rajarshi In this session, we will delve into the transformative impact of Artificial Intelligence (AI) on regulatory affairs, exploring how AI technologies are reshaping the landscape of compliance, risk management, and regulatory processes. As the regulatory environment becomes increasingly complex, the integration of AI offers unprecedented opportunities for efficiency, accuracy, and proactive compliance. However, it also brings forth new challenges and considerations for regulators and the regulated entities. The session will provide insights into the practical applications of AI along with examples of actual use cases. Regulator’s views will be shared wrt the challenges faced in overseeing AI driven processes and ensuring compliance with existing laws and standards, the need to regulate ensuring accountability, transparency and ethical considerations. The future is exciting and holds tremendous potential and needs to be “handled with utmost care” with collaborative efforts as the landscape continues to evolve.
Speaker(s)
DCTs: Opportunities and Challenges
Bhumi Vyas
Clinvigilant Research Private Limited, India
Director
Using AI in Regulatory Affairs
Asmita Nimkar
Nimkar 360 Pharma LLP, India
Director
Regulator’s Challenges in the Digital Era
Jayant Kumar
CDSCO, India
Deputy Drug Controller
Additional Contributing Panelist
Mohit Mhatre
GSK, India
Digital Health Delivery Lead
Additional Contributing Panelist
Mamta Sharma
PAREXEL, India
Director Regulatory Affairs
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