Question: In which types of INDs, the prior approval from the Institutional review board (i.e. IRB) is not needed, before starting the Clinical Trial? Answer: Thank you for answering the question🙂. During the emergency use IND we need not to take prior approval from IRB. However, we need to report the emergency treatment to an IRB within 5 working days. Let's stay tuned for more upcoming videos and such interesting questions.
Hi mam, Could you please recommend any certificate course from Udemy and demanded skill which Regulatory Affairs recruiters look for, It will help us in a great way mam. Thanks in advance mam 💎🙂
Thanks for the question Sujata. The expected review timeline for USFDA is 30 Days. However, there is no fixed timeline for IRB review/ approval completion, since there are many IRBs across the USA. Therefore they have their own timelines. These timelines may also sometimes vary due to the state regulations in the USA. The clinical study can only start once IRB approves and FDA reviews and /or provides No objection letter. I Hope this clarifies.
Hi Kirthiga, It depends on company's practice. However, it is Highly recommended to wait until we receive the acknowledgement from FDA. If we don't hear anything from FDA, we can reach out to them for confirmation.
Question: In which types of INDs, the prior approval from the Institutional review board (i.e. IRB) is not needed, before starting the Clinical Trial?
Answer: Thank you for answering the question🙂. During the emergency use IND we need not to take prior approval from IRB. However, we need to report the emergency treatment to an IRB within 5 working days. Let's stay tuned for more upcoming videos and such interesting questions.
Emergency IND....nice video mam with great animation
Thanks. We will keep it engaging with animations. The detailed answer will be revealed within this week. Let's stay tuned.
Great Job Neha.. keep it up
Thanks a lot 😊
Good job Neha ji.. I am also from pharma field.
Thank you:-)
Mam we can make writing basis vedio not oral basis
👏🏼
Hi mam,
Could you please recommend any certificate course from Udemy and demanded skill which Regulatory Affairs recruiters look for, It will help us in a great way mam.
Thanks in advance mam 💎🙂
How timelines differ for IRB and FDA.
Thanks for the question Sujata.
The expected review timeline for USFDA is 30 Days. However, there is no fixed timeline for IRB review/ approval completion, since there are many IRBs across the USA. Therefore they have their own timelines. These timelines may also sometimes vary due to the state regulations in the USA.
The clinical study can only start once IRB approves and FDA reviews and /or provides No objection letter. I Hope this clarifies.
Usually how many days do the companies wait after 30 days of IND submission to begin their clinical trials?
Hi Kirthiga, It depends on company's practice. However, it is Highly recommended to wait until we receive the acknowledgement from FDA. If we don't hear anything from FDA, we can reach out to them for confirmation.
Mam please make video on MAA in EU
Sure Rohit. This is in the list for future videos.
Ma'am how much do you get paid as a. Regulatory affairs associate Germany??
Emergency use IND.
Thanks for the answer. The detailed answer will be revealed within this week. Let's stay tuned :-)