Regulatory Affairs Explained Series Episode 4 | Electronic Common Technical Document (eCTD) Modules
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- čas přidán 5. 09. 2024
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Welcome to the Regulatory Affairs Explained Series! In Episode 4 we discuss Electronic Common Technical Document (eCTD) Modules
To learn more about INDs at the FDA visit this link: www.fda.gov/dr....
To learn more about NDAs at the FDA visit this link: www.fda.gov/dr...
To learn more about biologics (BLAs) at the FDA visit this link: www.fda.gov/va...
There is a lot to learn about regulatory affairs, so make sure you subscribe and turn on post notifications so you don't miss episode 5!
Commonly used acronyms:
FDA - Food and Drug Administration
IND - Investigational New Drug Application
NDA - New Drug Application
BLA - Biologics License Application
sNDA - Supplemental New Drug Application
sBLA - Supplemental Biologics License Application
CDER - Center for Drug Evaluation and Research
CBER - Center for Biologics Evaluation and Research
IB - Investigators Brochure
IMPD - Investigational Medicinal Product Dossier
WRO - Written Responses Only
BP or BB - Briefing Package or Briefing Book
MR - Meeting Request
EOP - End of Phase
INTERACT - Initial Targeted Engagement for Regulatory Advice on CBER producTs
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...
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#RegulatoryAffairs #Regulatory #RegulatoryExplained
Good video. Very important in module 2 is of course the clinical overview (2.5) as it is where you summarize your clinical value en risks and conclude how you put it in the company reference information.
And, when I started back in 2004 with our Agency, dossiers were coming in literally by the pallet. It was crazy, volumes and volumes of binders with pages and pages of information. I love eCTD!
These videos are so great! You really break things down for people just starting out. I cannot thank you enough for your time!
I am currently working on my CTD project for my class. This was a great overview of each module. Love these series!
Thank you!!!. Your explanation made understanding eCTD simple and straight to the point.
Thank you for such an informative video ! I loove these explained series 👩🏼🔬
Thank you for the video and the advices! They are really helpful to me, being a RA novice. I am coming from 8 years of R&D, but I decided to switch to regulatory affairs few months ago. I have followed a RA training and soon I will get the certification, so I am hopefully going to get my first RA job. Honestly have still difficulties to imagine the everyday job, but I will see it soon.
I have a PharmD background with at least 3 years of R&D experience. I love RA and PV but finding it difficult to break into one of those areas. It's almost as if the recruiters want you to stay in R&D only lol. But im curious what did you do different to land a role in RA? Any tips would be appreciate thanks :)
Thank you for informative session
Love your videos please keep doing them :)
Hi-
Your videos are very informative. Thank you! I’m new to RA and the CRO I work for handles mostly IVD. Can you cover medical devices and the FDA in one of your episodes?
Thanks!
Do you do any kind of resume reviews? I've made it far in the interview process for regulatory affairs but I'm struggling to get offers
Hello, I have a question, What does it mean when you request for the module I 2 XML files?
Thanks for the detailed information. 👍🏾 🖖🏾👌🏾👍🏾🤙🏾🖤🤎