What is Investigational New Drug (IND) Application? | Regulatory Learnings | Drug Regulatory Affairs

Welcome to the PharmaCamp with Neha. With this video channel. I would like to spread knowledge about the pharmaceutical world. This is a small initiative from my side to share knowledge with the world, as I feel education is the best gift one can receive or give back to society.
Are you a working professional who wants to upgrade your skills? OR a student who wants to make a career in pharmaceuticals? OR are you a person who is interested to learn about the regulatory systems? Then this TH-cam channel is for you.
In this video, we will about US FDA Investigational New Drug (IND) Application. In my upcoming video, I will provide the stepwise approach for these IND applications. Therefore, this video will serve as the basis for those upcoming videos to explain the concept of INDs.
Welcome to PharmaCamp • Welcome to PharmaCamp ...
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About me:
I am Neha Parashar, working as a Senior Manager in a pharmaceutical company and based in Germany. I am a passionate healthcare professional, an educator, and a mentor.
LinkedIn: / neha-parashar
LinkedIn Articles on various Regulatory Topics:
1. Regulatory Pathways for Expedited Access of Medicines / regulatory-pathways-ex...
2. Step-wise Regulatory approach for the Paediatric drug Development / step-wise-regulatory-a...
3. Designing the Global Regulatory Strategy for the Development of Orphan Medicinal Products
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4. Step wise approach for the Quality Risk Management (QRM) in pharmaceutical industries / step-wise-approach-qua...
5. Step-wise regulatory approach for the assessment of process related impurities in biological products / step-wise-regulatory-a...
6. Step-wise approach for sterilisation package preparation in regulatory dossiers for biologicals and other liquid sterilised products / step-wise-approach-ste...
7. Step-wise approach for regulatory risk assessment of adventitious agents in biologicals products / step-wise-approach-reg...
8. Five Step Approach to Assess the Equivalency Requirements of Topical Products / five-step-approach-ass...
Disclaimer- This video channel is for educational purposes. These are purely my views and not any recommendations. The channel does not represent the views of the organization I am associated with, and it has no connection with my current organization.

[@vrushabpipada5346]

Emergency IND....nice video mam with great animation

[@pharmacamp]

Thanks. We will keep it engaging with animations. The detailed answer will be revealed within this week. Let's stay tuned.

[@Parikiduniya17]

Great Job Neha.. keep it up

[@pharmacamp]

Thanks a lot 😊

[@pharmacamp]

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.

[@anandshethi8742]

👏🏼

[@indiansoul]

Good job Neha ji.. I am also from pharma field.

[@pharmacamp]

Thank you:-)

[@sohailahmed3610]

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 💎🙂

[@rajdeepbaruah1714]

Mam we can make writing basis vedio not oral basis

[@kirthigadeviss7795]

Usually how many days do the companies wait after 30 days of IND submission to begin their clinical trials?

[@pharmacamp]

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.

[@sheikhnoman1651]

Ma'am how much do you get paid as a. Regulatory affairs associate Germany??

[@sujatadas8937]

How timelines differ for IRB and FDA.

[@pharmacamp]

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.

[@rohitghatul3049]

Mam please make video on MAA in EU

[@pharmacamp]

Sure Rohit. This is in the list for future videos.

[@poonamdongre6411]

Emergency use IND.

[@pharmacamp]

Thanks for the answer. The detailed answer will be revealed within this week. Let's stay tuned :-)