The document outlines the stages of drug development, including preclinical studies, clinical trials, and the regulatory approval process. It emphasizes the importance of clinical data management in generating reliable data, as well as the role of the regulatory affairs department in obtaining and maintaining product approvals. Upon FDA approval, a drug enters post-marketing surveillance, requiring periodic safety updates from the manufacturer.

1. DRUG
DEVELOPMENT
BY _
VIKAS
KHEDKAR
[ R.C.PATEL INSTITUTE OF
PHARMACY, SHIRPUR ]

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3. NCE
Preclinical
Studies
INDA
Clinical
Trials
NDA
APPROVAL
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5. For Preclinical studies,,
 Submit the RESEARCH PROTOCOL To CPCSEA by IAEC for preclinical trials
.
 .
After approval Make protocol for clinical trials CRF & ICF
RECRUITMENT Selection of PI ICMR (Indian
GCP)
Monitoring DATA ENTRY Statistical analysis & Final
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7. Clinical Data Management.
 What is mean clinical data management?
Clinical data management (CDM) is a critical
process in clinical research, which leads to
generation of high-quality, reliable, and statistically
sound data from clinical trials. Clinical data
management ensures collection, integration and
availability of data at appropriate quality and cost.
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8. REGULATORY AFFAIRS
1) The regulatory affairs (RA) department of a pharmaceutical
company.
2) RA is responsible for obtaining approval for new
pharmaceutical products.
3) RAAlso responsible for ensuring that approval is
maintained for as long as the company wants to keep the
product on the market.
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9. DEPARTMENTS INVOLVED
FOR PROVIDING THIS DATA
TO RA…..
F & D
R & D
QA
QC
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10. MAIN WORK OF
RA
I] TO PREPARE CTD/ ECTD.
 Itincludes,,,
Module1tomodule5.
Most important module is module 3
It is nothing but the CMC/ ICH.M4
Module 3 composed of drug substance and drug product formulation.
To Prepare Complete dossier.
what is dossier?
It involves ------
👉 3.2.S & 3.2.P
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11. REGULATORY AFFAIRS
DEPARTMENT SUBMITTED THE
DATA OF DRUG SUBSTANCE TO
WHOM ?
A Drug Master File (DMF) is a submission to the
Food and Drug Administration (FDA)
SOURCE: https://www.nbcnews.com/news/amp/ncna957886

12. Once FDA approves a drug, the post-
marketing monitoring stage begins. The
sponsor (typically the manufacturer) is
required to submit periodic safety updates to
FDA. FDA meets with a drug sponsor prior to
submission of a New Drug Application.
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13.  Post surveillance marketing.
 Upto 20 YEARS

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