Step-wise Approach for Investigational New Drug (IND) Application? | Regulatory Learnings | DRA

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 ...
What is Clinical Trial? • What is Clinical Trial...
What is Investigational New Drug (IND) Application • What is Investigationa...
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
/ designing-global-regul...
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.

[@LearnPharma480]

Nice information

[@pharmacamp]

Thank you.

[@khushijawanjar5765]

Does IND protocol changes phase wise?

[@pharmacamp]

Yes Khushi, we need to submit a new protocol with new submission for each phase.