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Meet ELSA: USFDA Launches Agency-Wide AI Tool to Optimize Performance
What if the agonizing wait for drug approvals could be slashed from days to minutes? Imagine a future where breakthrough therapies reach...

Sharan Murugan
Jun 22 min read
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USFDA Announcement: Shortening the Drug Approval Process- Integration of Generative AI by June end & Completion of First AI-Assisted Scientific Review
The U.S. Food and Drug Administration (FDA) has marked a significant milestone in its digital transformation journey by announcing the...

Sharan Murugan
May 132 min read
44 views
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CIOMS Working Group Draft Report: Artificial Intelligence in Pharmacovigilance: Key Takeaways
The field of pharmacovigilance (PV) —the science of detecting, assessing, understanding, and preventing adverse effects or any other...

Sharan Murugan
May 133 min read
68 views
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EMA Network Data Steering Group workplan 2025-2028: Leveraging Data and AI for Enhanced Medicine Regulation
In the evolving landscape of medicines regulation, data and artificial intelligence (AI) have become pivotal tools to enhance public and...

Sharan Murugan
May 113 min read
31 views
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Announcing Veeva AI: A Bold Leap Toward Intelligent Automation in Life Sciences
The world of pharma and life sciences is abuzz with a major announcement: Veeva Systems has just unveiled Veeva AI , a groundbreaking...

Sharan Murugan
Apr 293 min read
130 views
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EMA's New AI Work Plan: Shaping the Future of Medicines Regulation
The European Medicines Agency (EMA) has unveiled a comprehensive Artificial Intelligence (AI) Work Plan to guide the integration of AI...

Sharan Murugan
Mar 312 min read
38 views
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USFDA Draft Guidance: Considerations for the Use of Artificial Intelligence to Support Regulatory Decision
The U.S. Food and Drug Administration (FDA) released a draft guidance earlier today (07 January, 2025) outlining " Considerations for...

Sharan Murugan
Jan 72 min read
41 views
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UK MHRA Press Release Trials Innovative AI Technologies in Regulatory Pilot Scheme
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has launched (4th December 2024) a groundbreaking pilot scheme "...

Sharan Murugan
Dec 4, 20242 min read
29 views
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EMA: Harnessing AI in Medicines Regulation: The Role of Large Language Models (LLMs)
The advancement of Artificial Intelligence (AI) is transforming many industries, and the pharmaceutical and regulatory sectors are no...

Sharan Murugan
Sep 15, 20242 min read
25 views
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Artificial Intelligence in Regulatory Affairs
Artificial Intelligence (AI) is a broad term that encompasses many different things and is a kind of intelligence that is created by a...

Sharan Murugan
Sep 21, 20223 min read
4,230 views
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Free eBook- CAPA in the Pharmaceutical and Biotech Industries
According to the U.S. Food and Drug Administration (FDA), the purpose of a "CAPA program is to collect information, analyze information,...

Sharan Murugan
May 26, 20221 min read
298 views
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101 Great Answers To Interview Questions
Interviews are tough! At least people like me, have always struggled to answer in interviews. Whatever or How much ever we prepare, we...

Sharan Murugan
Apr 17, 20221 min read
76 views
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Free 50+ Pharma eBOOKS
Hi Guys! You have been my supporters and wellwishers from the day I published this website. As you have been supportive of me from day...

Sharan Murugan
Dec 31, 20212 min read
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Sharan Murugan
Nov 28, 20211 min read
499 views
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