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Novotel Mumbai Juhu Beach

2024 年 09 月 24 日 8:00 上午 - 2024 年 09 月 25 日 6:00 下午

Balraj Sahni Marg, Juhu Beach, Mumbai 400049, India

DIA India Annual Meeting 2024

Confluence of Care: Pharmacovigilance, Clinical Innovation, Regulatory Sciences, and Medical Devices Elevating Patient Safety

Track 2 Session 2: Leveraging Technology in Clinical Research and Regulatory Affairs

Session Chair(s)

Manjusha  Rajarshi

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)

Bhumi  Vyas

Bhumi Vyas

Director, Clinvigilant Research Private Limited, India

DCTs: Opportunities and Challenges

Asmita  Nimkar

Asmita Nimkar

Director, Nimkar 360 Pharma LLP, India

Using AI in Regulatory Affairs

Jayant  Kumar

Jayant Kumar

Deputy Drug Controller, CDSCO, India

Regulator’s Challenges in the Digital Era

Mohit  Mhatre

Mohit Mhatre

Digital Health Delivery Lead, GSK, India

Additional Contributing Panelist

Mamta  Sharma

Mamta Sharma

Director Regulatory Affairs, PAREXEL, India

Additional Contributing Panelist

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