Regulatory Open Forum

What are the various risks with the overall development plan that can affect the submission of a drug application? Would be grateful if someone can give me some pointers .

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Shivam Mishra


Québec QC
Canada
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​Hello Shivam - Regarding you query, you may be interested in a recently published article based on a 2019 RAPS Convergence Session Estimating the Probability of Regulatory Registration Success Posted 13 February 2020 | By Jennifer R. Weidman, PhD and Kimberly Belsky, MS  Estimating the Probability of Regulatory Registration Success  

Raps		remove preview
Estimating the Probability of Regulatory Registration Success This article discusses how to estimate the probability of regulatory/registration success for pharmaceutical products in development. View this on Raps >

https://www.raps.org/news-and-articles/news-articles/2020/2/estimating-the-probability-of-regulatory-registrat


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Kimberly Belsky
Head of Regulatory Policy and Intelligence
New Jersey
United States
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Original Message:
Sent: 20-Apr-2020 22:45
From: Shivam Mishra
Subject: Risks that can affect a submission of new drug

What are the various risks with the overall development plan that can affect the submission of a drug application? Would be grateful if someone can give me some pointers .

---------------------------------
Shivam Mishra


Québec QC
Canada
---------------------------------