Clinical Research / Regulatory affairs
by samitfm · Published September 28, 2024 · Last modified December 26, 2024
Data Requirements for Step 2: Preclinical Studies Preclinical Studies 7.1 Prerequisites for Conducting Preclinical Studies Preclinical studies Before initiating preclinical studies, the applicant must adhere to RCGM guidelines, which include demonstrating the consistency of...
Clinical Research / News Articles / Regulatory affairs
by samitfm · Published April 27, 2024 · Last modified December 26, 2024
Module 5 clinical summary report regulatory submission module 5 on clinical summary reports. Module 5 clinical summary report regulatory submission , A clinical summary report is a document that provides a summary of the...
Clinical Research / News Articles / Regulatory affairs
by samitfm · Published April 27, 2024 · Last modified January 10, 2025
Non-clinical Regulatory affair module 4 Non-clinical Regulatory affair module 4 Regulatory non-clinical Regulatory Affairs Non-Clinical Module 4 is an essential component of the pharmaceutical regulatory submission process. It contains detailed information related to the...
Clinical Research / News Articles / Regulatory affairs
by samitfm · Published April 27, 2024 · Last modified December 30, 2024
Understanding the 5 Modules of Regulatory Affairs in eCTD/CTD/ACTD Format-Part 1 Regulatory Affairs Module 1-Understanding the 5 Modules Understanding the 5 Modules of Regulatory Affairs , the contents of module 1 in regulatory affairs...
Clinical Research / News Articles
by samitfm · Published April 27, 2024 · Last modified January 10, 2025
Clinical Study Report-E3 structure Clinical Study Report First, is important to understand the definition, requirements, and potential uses of a CSR. The report is a comprehensive look at all the data produced in a...
Clinical Research / News Articles
by samitfm · Published April 25, 2024 · Last modified January 10, 2025
Clinical Trial Management & Part 11 Compliance Clinical Trial Management Background What is Good Clinical Practice? Clinical Trial Management A process enabling reliable decisions about allowing a medical product to be marketed Product Approval...
Clinical Research / News Articles
by samitfm · Published April 22, 2024 · Last modified January 10, 2025
Navigate Liabilities in Clinical Research Navigate Liabilities Clinical research is a high-risk activityLiability cannot be waived Control Risk & Liability Navigate Liabilities Liability can not be waived but risk can be controlled.This ethical responsibility...
Clinical Research / News Articles
by samitfm · Published April 16, 2024 · Last modified January 10, 2025
Development of clinical trials information system CTIS Development Development of clinical trials information system Development of clinical trials information system Clinical trials are essential for the development of new medical treatments, therapies, and procedures...
Clinical Research / News Articles
by samitfm · Published April 16, 2024 · Last modified January 10, 2025
Bioequivalence Trial Information -SAHPRA GENERAL INSTRUCTIONS: Bioequivalence Trial Information Please review all the instructions thoroughly and carefully prior to completing the Bioequivalence Trial Information Form (BTIF). Provide as much detailed, accurate and final information as...
Clinical Research / News Articles
by samitfm · Published April 16, 2024 · Last modified January 9, 2025
Clinical data management (CDM) Clinical data management (CDM) consists of various activities involving the handling of data or information that is outlined in the protocol to be collected/analyzed. CDM is a multidisciplinary activity. Introduction ...
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