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!
These videos are so great! You really break things down for people just starting out. I cannot thank you enough for your time!
Great video, very useful. Hugs, directly from Brazil.
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
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!
Love your videos please keep doing them :)
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. 👍🏾 🖖🏾👌🏾👍🏾🤙🏾🖤🤎