Dossier Preparation As Per CTD Format | Regulatory Affairs | NDA | ANDA

Dossier Preparation As Per CTD Format | Regulatory Affairs | NDA | ANDA | MAA

Рет қаралды 34,937

2 жыл бұрын

In this lecture, we discussed how to prepare pharmaceutical dossiers as per common technical document (CTD) format for submitting various types of applications such as New drug application (NDA), Abbreviated new drug application, and marketing authorization application (MAA) to the regulatory agency.
We discussed the following:
Common technical document (CTD)
CTD Modules types
Module 1- Administrative and Prescribing Information
Module 2- CTD Summary
Module 3- Quality
Module 4- Non-clinical Study Reports
Module 5 - Clinical Study Reports
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Thanks for watching this video !!!!!!!!

Пікірлер: 32

@elizabethholloway6945 Жыл бұрын

Thank you for such a clear and concise explanation. Appreciate it!

@priyankagulve1163 Ай бұрын

Thank you sir.... It's Very short and easy to understanding

@Masters007Rk Жыл бұрын

Thank you sir for this grateful and concise knowledge about CTD

@Swadaksh Жыл бұрын

I know I watched too late but, this video is very informative for people who preparing for RA interview... Sir please make video on ICH Q8 as well and many more RA videos. Thank you

@user-fu9ts1eo1i Жыл бұрын

Thank you very much it was really helpful.

@shjaswal6857 Жыл бұрын

Thanks for sharing sir

@muazhababa6858 3 ай бұрын

all the respect Sir

@sofiaguzzarlamudi7933 Жыл бұрын

This is really helpful

@darshanasolanki4978 Жыл бұрын

It's is really helpful sir keep going and please share e-ctd . Thanks

@user-od8ik1kh5w 8 ай бұрын

Very nice information sir

@letsstart4505 2 жыл бұрын

Kindly show some kind of filled ctd dossier

@earththrill2541 2 жыл бұрын

This is very informative video❤️

@ankitapatil8676 2 жыл бұрын

Sir want your guidance what should I do after my graduation in pharmacy. Should I go for PG in QA or regulatory affairs. OR PG diploma course in clinical data management / covigillance

@pateljeel8589 2 жыл бұрын

Can you share a how to prepare dossier for NDA APPLICATION in INDIA ?.

@ArvindYadav-ty7hm Жыл бұрын

Very nice

@venkataratnams5406 2 жыл бұрын

Nice sir

@alijamali.rasupport.official Жыл бұрын

Great Information

@EducationTricks99 Жыл бұрын

Glad it was helpful!

@shirishareddyvlogskurnool6605 2 жыл бұрын

Very useful 👌 subscribed, bell hitted thankyou

@dheerajsharma-ok4vl Жыл бұрын

Sir i have done my msc in organic chemistry and currently working in quality control, can i join RA department in pharmaceutical companies or IT Companies

@sylveriaegbujua1730 4 ай бұрын

Thanks, sir for this wonderful and educative video. As a pharmacology student, Can I work in Regulatory affairs with my degree? Thank you

@shjaswal6857 Жыл бұрын

Really informative

@kamsalinagaraj9856 Жыл бұрын

😱

@poojasadgir7659 2 жыл бұрын

Plz show the actual document of Ctd and actd as like industrial format so it's better to understand

@EducationTricks99 2 жыл бұрын

Thanks for your suggestion I will try

@anuptambuskar 2 жыл бұрын

Sir plz make a detailed video on ICH guidelines ... Ur videos are very understandable and language is so clear to understand

@aaromalsatheesh1413 Жыл бұрын

www.fda.gov/media/150309/download

@officialpravin1110 Жыл бұрын

Still waiting

@priyankakekan5024 6 ай бұрын

But how to learn all the models..??

@priteshgahine1970 Жыл бұрын

Sir, I want more Information Related to these topic and Domain (Regulatory Affairs) you are describing so smoothly and it is so understandable. We got only 2 Videos on these sir. We will really appreciate, if you made a Video on our Request. Thank you Sir for your Support and Guidance. Thanks a Lot Sir