Regulatory Pharma Blogs
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 key clinical findings from a clinical study. It is an important document that provides a comprehensive overview of the study and …
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 non-clinical aspects of a drug\’s development, including the drug substance, drug product, and toxicology data. To start the submission process for …
eCTD-module-3-drug-products Understanding the 5 Modules of Regulatory Affairs in eCTD/CTD/ACTD Format-Part 2 eCTD-module-3-drug-products Module 3 drug products eCTD-module-3-drug-products Module 3 of a regulatory submission for a drug product plays a crucial role in the approval process, as it includes information about the product\’s quality, safety, and efficacy. In this response, we will explore the regulatory …
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 may vary depending on the specific training program, but generally, it covers the following topics: Introduction to Regulatory Affairs: This topic …
Regulatory Affairs Requirement for submission dossier Regulatory Affairs Requirement: USFDA Regulatory Affairs Requirement The United States Food and Drug Administration (FDA) is responsible for ensuring the safety and effectiveness of a wide range of products, including drugs, medical devices, food, and cosmetics. In order to comply with FDA requirements, regulatory affairs professionals must have a …
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 study, presented in text, tables, and figure formats. It will often include discussions and conclusions that provide context to the …
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 Factors Product is safe Treatment is effective for disease or condition it is meant to treat clinical trials Clinical Research Project …
Difference between ACTD and CTD, eCTD Regulatory affair Dossier preparation eCTD Regulatory Overview The electronic Common Technical Document (eCTD) is an electronic submission format for regulatory documents that is widely used in the pharmaceutical and biotech industry. The eCTD is based on the International Conference on Harmonisation (ICH) Common Technical Document (CTD) format and is …
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 should be shared by Investigators (& HC profession)Sponsors (& Industry)Study sites administrationRECs Basic considerations What is the risk? Is it fair …
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 that improve human health. Clinical trials require a vast amount of data, and managing this data is a complex task. Therefore, …