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!
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 :)
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!
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!
Great video, very useful. Hugs, directly from Brazil.
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 :)
Love your videos please keep doing them :)
Thank you for informative session
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!
Hello, I have a question, What does it mean when you request for the module I 2 XML files?
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
Thanks for the detailed information. 👍🏾 🖖🏾👌🏾👍🏾🤙🏾🖤🤎