Recent Events
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Nov
20
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Mastering Regulatory Submissions: Best Practices and Compliance
The workshop will explore opportunities and challenges in statistical and programming topics, focusing on regulatory submissions as crucial milestones for pharmaceutical organizations post-clinical trial reporting. Quality regulatory submissions are essential for expediting the review, evaluation, and approval of new products, ensuring patient safety and optimizing research investments, and reducing the time from drug discovery to market access. This workshop gives an overview of health authorities like FDA, EMA, and PMDA, and the roles of programmers and statisticians in regulatory submissions. The workshop will also focus on how sponsors can perform risk benefit analysis for health technology assessment (HTA) and respond to Health Authority questions on data. The session will also see industry professionals sharing their experiences in successfully addressing regulatory queries. As the FDA may sometimes evaluate product approval through Advisory Committee (AdCom) meetings, we will also focus on how sponsors can prepare for potential questions arising from AdCom meetings. Overall, the workshop will cover various aspects of regulatory submissions across diverse therapeutic/disease areas, through case studies while focusing on key roles and responsibilities of statisticians and statistical programmers.
Nov 20 2023
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Sep
12
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Industry-Academia Connect
Indian Association for Statistics in Clinical Trials (IASCT) is excited to announce an offline event to be held on 12-Sep-2023 between Industry and Academicians/Students at Bharathiar University, Coimbatore.
Sep 12 2023
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May
04
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Conspic 2023
The conference encourages statisticians, statistical programmers and analysts from the healthcare industry to convene, and provides a platform to share novel ideas on various topics such as statistics, programming and analytics related to clinical research and to network and strengthen statistics and statistical programming community in India.
May 04-06 2023 | Radisson Blu Bengaluru Outer Ring Road, 90/4, Outer Ring Rd, Marathahalli Village, Marathahalli, Bengaluru, Karnataka 560037 INDIA
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Apr
06
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Role of Machine Learning and Artificial Intelligence in Clinical Trials
Artificial intelligence (AI) and Machine Learning (ML) is shaping the future of humanity across nearly every industry. You probably interact with AI daily and don’t even realize it. Many people still associate AI/ML with science-fiction dystopias, but that characterization is waning as AI develops and becomes more commonplace in our daily lives. Today, AI is a household name – and sometimes even a household presence (Hi, Alexa! Hey Google!). Over the last several years, the use of AI in the pharma and biomedical industry has gone from science fiction to science fact. The success rate of clinical trials has been on raise since 2015 (Nature’ 2022). Researchers in academia and the pharmaceutical industry are turning to AI to increase the success rate in Clinical Trials. Fueled by the rapidly increasing amounts of medical data that are available to researchers, including those provided by electronic health records (EHR) and wearable devices, powered by ML & AI have the potential to save billions of dollars, to speed up medical advances and to expand access to experimental treatments. Role of AI & ML in Pharmaceutical Industry, specifically focusing at multiple levels in Clinical Trials varies from optimizing the clinical trial design, patient enrichment and recruitment, site selection, patient monitoring & adherence and pharmacovigilance. In this two day workshop, we focus on ML & AI in Clinical Trials and try to give an idea on how AI & ML are reshaping the clinical trials. ML & AI adds value across the spectrum of clinical trials, from preclinical drug discovery to pre-trial planning through study execution to data management and analysis.
Apr 06-07 2023 | Virtual
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GSTIN Number
29AAATI6873R1ZN
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IASCT Registration Number
SOR/BLU/DR/606/2008-09