Regulatory Affairs Explained Series Episode 5 | Module 3 - Chemistry, Manufacturing & Controls (CMC)

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Welcome to the Regulatory Affairs Explained Series! In episode 5 we discuss Module 3 - Chemistry, Manufacturing & Controls (CMC)!
Check out the other episodes in this series!
Regulatory Affairs Explained Episode 1: FDA, Application Types, Regulatory Pathways & More
• Regulatory Affairs Exp...
Regulatory Affairs Explained Episode 2: Requesting Meetings, Meeting Types, Timelines & More • Regulatory Affairs Exp...
Regulatory Affairs Explained Series Episode 3 | Common Documents, Forms, ClinicalTrials.gov & More • Regulatory Affairs Exp...
Regulatory Affairs Explained Series Episode 4 | Electronic Common Technical Document (eCTD) Modules • Regulatory Affairs Exp...
I hope you enjoyed watching this series! If you are interested in more regulatory affairs content make sure you subscribe to my channel!
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[@rbronsing]

Once again a great video! CMC is very important and a little overlooked, I believe. But, for a Regulatory Explained topic, regulatory accelerations and designations would be interesting. I mean things like breakthrough therapy, accelerated approval or priority review. Will we see a future for Rare pediatric disease review vouchers? Of course this is a big topic, but I think it is important as we all want to be faster and these processes can help.

[@alexandragousby962]

I watched the whole series and the info you provided is so detailed! Thanks for sharing!

[@lam8772]

I love your videos! Can you make more!! Love these.

[@kelvinroddy6637]

Great video! Your explanations and section breakdowns are very helpful. Would you be willing to do a series on ODD and other "Fast Track" designations and how to best position a product for these type of designation approvals? You are awesome and thanks!

[@elizabethholloway6945]

Great overview! Thank you.

[@sylwia8811]

Great overview as always!

[@opemipodurodola]

Great Video and Happy Birthday.

[@opemipodurodola]

🚶🏾

[@vahoranadim5844]

Hi I am a bachelors degree holder in pharmacy which one is good to pursue Post graduation in regulatory affairs or master in regulatory affairs ?

[@vahoranadim5844]

Actually I am a international student and I want to make my career in pharmaceutical and it’s regulations but I am little bit confuse what to pursue ? Is regulatory affairs is the right choice ?

[@biotechno100]

Thanks for the video and effort plus great idea.
CMC poorly understood I agree. Gentle feedback - not sure the value for telling the audience what Module 3 is and then list the numbers and specific sections and then simply tell us at the 7 minute mark that you could be wrong and to check the 3 ticked items before you submit. I mean instead of making the tick boxes and animations telling us to check, just verify yourself (for us) and avoid that part of the video?
I mean thats why we clicked a video that says Regulatory affairs explained for CMC. Plus you give a very high level explanation that goes little further than the title/section headers themselves.
Not being a troll here. Just I think with more in depth exploration on each section (one paragraph each) then you could really excel here as you have a lovely presence and voice for narration. Just this video doesn't teach us anything other than what an excipient is and DS DP differences (and with google we can do that) we are looking for the nuanced info (I might be biased as I have got a DP all the way through trials with my company (but as CMC and disruptive technology is coming more commonplace, I always need to fluff up knowledge as you say, and pivot)..... Maybe the very high level is for some beginner people I suppose.
Just advice. Take it or leave it. Nice video either way.
P.S came across it looking for Adenovirus CMC sections for IMPD submission type search. Ha

[@kyabdul]

This specific video and series is for ppl who know absolutely nothing about the fundamentals of regulatory. So you know to google DS and DP but my normal viewers don’t even know that’s something that should be googled. Im also not a cmc expert. Im a global clinical/nonclinical strategist so my extrapolation on cmc likely will not be up to your standards because as you know cmc and what I do require 2 different levels of expertise. It’s possible narrative videos will arise in the future but as for now this video was just a 101 for beginners trying to understand what is regulatory in the first place. Nonetheless your advice is received lol. At your level it seems you and I would be colleagues.