Educo Life Sciences’ Post

🎓 Register for the free-to-attend module one of our online course CMC Essentials: An Overview of CMC Development taking place this September 30. During this module you will gain an introduction to drug development and CMC and gain a comprehensive understanding of the regulatory framework. #eudolifesciences #cmcessentials #module1

CMC filling Question-based Review (QbR) for Sterility Assurance of Terminally Sterilized Products #regulatoryaffairs #regulatory #regulatorysubmission #cmc #dossier #regulatoryscience #regulation #ICH #regulatorysubmission #cmc

ℹ Let’s take a look at what some of our attendees have said about the previous CMC Regulatory Compliance for ATMPs online training course. This 3-day CMC regulatory compliance training is designed to keep you up to date on emerging ATMP topics. You will learn how to develop good CMC-compliant regulatory practices and avoid market-approval delays. This course is suitable for all those involved in CMC development and implementation for ATMPs. The next live online training course will be on 13 – 15 March 2024 🗓 #ATMPs #pharma #regulatory #onlinecourses #SymmetricTraining

Navigate CMC challenges with expert insights. Learn how to enhance your regulatory submissions! #RegulatoryCMC #IND @enkrisi

Navigate CMC challenges with expert insights. Learn how to enhance your regulatory submissions! #RegulatoryCMC #IND @enkrisi

The CMC module is the heart of a dossier of any drug product , as it covers all the important aspects starting from the raw materials to the finished product along with all the primary information like brand name, source of active ingredient, dosage form, followed by manufacturing steps involved, its validation and other relevant information. Here’s a detailed guide for the preparation of the CMC module dossiers for License application submission to the regulatory authority. #CMC #CTDmodule #Dossiers

FDA published new guidelines for validation of analytical procedures (AMV) This guidance presents elements for consideration during the validation of analytical procedures included as part of registration applications. Analytical procedure validation forms a part of the analytical procedure life cycle, as described within the International Council for Harmonisation (ICH) guidance for industry Q14 Analytical Procedure Development (March 2024) (ICH Q14). This ICH guidance for industry, Q2(R2) Validation of Analytical Procedures (ICH Q2), provides guidance on selection and evaluation of the various validation tests for analytical procedures. This guidance includes a collection of terms and their definitions, which are meant to bridge the differences that often exist between various compendia and documents of the ICH member regulatory authorities. The objective of validation of an analytical procedure is to demonstrate that the analytical procedure is fit for the intended purpose. Further general guidance is provided on validation studies for analytical procedures. #fda #regulatoryaffairs #regulatoryupdates #regulatorystrategy #regulatory #regulatoryrequirements #validation #analyticaldevelopment #drugs #regulatorysubmissions #generic #regulatorycompliance #approval #pharmaceuticalcompanies

Interesting webinar on 25th JAN 24 about CMC Management. Will be there. Who else?

CMC part is the heart of a drug product dossier, as it covers all the important aspects. Here’s a detailed guide for the preparation of the CMC module dossiers for License application submission to the regulatory authority.