What is Clinical Trial? | Regulatory Learnings | Drug Regulatory Affairs

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PharmaCamp

PharmaCamp

Күн бұрын

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 KZfaq channel is for you.
Welcome to PharmaCamp • Welcome to PharmaCamp ...
Description:
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Welcome to an extensive and insightful journey through the world of Clinical Trials! In today's video, we'll be demystifying Regulatory Learnings and peeling back the layers of Drug Regulatory Affairs. Our aim? To empower you with the knowledge of what a Clinical Trial is, and how it's intricately woven into the fabric of regulatory science.
🔖 Video Content 🔖
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We begin by diving deep into the heart of Clinical Trials, discussing their purpose, importance, and the role they play in the development of new drugs. We'll explore the steps involved, from design and planning, through to the execution and analysis of a Clinical Trial, including crucial regulatory guidelines.
Moving on, we'll unravel the complexities of Regulatory Learnings, shedding light on its significance in the sphere of Clinical Trials. This will include understanding the regulatory requirements, protocols, and compliance strategies necessary for successful trial conduct.
In the final segment of our video, we turn the spotlight on Drug Regulatory Affairs. We'll delve into the intricate procedures, documentation, and submissions associated with this field, and how it interlinks with Clinical Trials.
This all-encompassing view into Clinical Trials and its allied fields will not only enhance your understanding but will also provide a practical perspective, aiding you in your professional journey.
👍 Like, Share, Subscribe! 👍
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Did you find this video helpful? Hit the like button to let us know! Share it with your colleagues or anyone who may benefit from this information. Subscribe to our channel and click the bell icon to stay updated with more informative content from us. Your support motivates us to create more such videos.
🔑 Tags 🔑
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#ClinicalTrials, #RegulatoryLearnings, #DrugRegulatoryAffairs, #ClinicalResearch, #DrugDevelopment, #RegulatoryCompliance, #DrugSubmission
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.

Пікірлер: 17
@pharmacamp
@pharmacamp 2 жыл бұрын
Question- Which Clinical Trial is also called ''Microdosing Clinical trial''? Answer- I am glad to see that most of you have answered this question rightly. Phase-0 Clinical trial is called as Microdosing clinical trial🙂
@jakeeraabdul5922
@jakeeraabdul5922 10 күн бұрын
Please make a video on clinical trials for cancer drugs
@rameshaachariar3827
@rameshaachariar3827 2 жыл бұрын
Phase 0 is the micro-dosing study..
@pharmacamp
@pharmacamp 2 жыл бұрын
Thanks for the response. We will reveale the detailed answer within this week. Let's stay tuned.
@LearnPharma480
@LearnPharma480 2 жыл бұрын
Good and clear explanation mam
@pharmacamp
@pharmacamp 2 жыл бұрын
Thanks:-)
@reddyganesh6984
@reddyganesh6984 2 жыл бұрын
Hi Neha, Thanks for sharing the knowledge. Ur videos are very informative I have one doubt about PCT. May I know the data package required to conduct preclinical trial (PCT) in India for biosimilars drug product.
@vrushabpipada5346
@vrushabpipada5346 2 жыл бұрын
phase 0 clinical trial
@pharmacamp
@pharmacamp 2 жыл бұрын
Thanks for the answer. The detailed answer will be revealed within this week. Let's stay tuned :-)
@gaytriamrutkar5952
@gaytriamrutkar5952 2 жыл бұрын
Please make video on biosimilars
@pharmacamp
@pharmacamp 2 жыл бұрын
Sure Gaytri, I will add this topic in my list for upcoming videos.
@LearnPharma480
@LearnPharma480 2 жыл бұрын
Phase 0 micro dosing
@pharmacamp
@pharmacamp 2 жыл бұрын
That's correct answer👍
@Ayushsharma-bq2uw
@Ayushsharma-bq2uw 2 жыл бұрын
Hindi mai nhi aa skta aa yeh video
@pharmacamp
@pharmacamp 2 жыл бұрын
I will try in future.
@samrat406
@samrat406 2 жыл бұрын
Phase 0
@pharmacamp
@pharmacamp 2 жыл бұрын
Correct answer :-)
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