Regulatory Affairs Explained Series Episode 4 | Electronic Common Technical Document (eCTD) Modules

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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

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2 окт 2024

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Комментарии : 13

@rbronsing 2 года назад

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!

@meghanbruno3938 2 года назад

These videos are so great! You really break things down for people just starting out. I cannot thank you enough for your time!

@jaderagland161 2 года назад

I am currently working on my CTD project for my class. This was a great overview of each module. Love these series!

@snipeed_00 2 года назад

Thank you for such an informative video ! I loove these explained series 👩🏼‍🔬

@joynwabueze8 2 года назад

Thank you!!!. Your explanation made understanding eCTD simple and straight to the point.

@MEYOU-yb6kr 2 года назад

Thank you for informative session

@samiafarah1773 2 года назад

Love your videos please keep doing them :)

@danimachiste 2 года назад

Hello, I have a question, What does it mean when you request for the module I 2 XML files?

@ajredwine1097 2 года назад

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!

@MARiiNAxoxo 2 года назад

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

@pettirosso252 2 года назад

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.

@koftownbabe 2 года назад

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 :)