Orphan Drug Development | Episode 01- What is Orphan Drug? | Rare Disease | Drug Regulatory Affairs

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PharmaCamp

PharmaCamp

Жыл бұрын

Welcome to the PharmaCamp with Neha. This is a small initiative from my side to share knowledge about the pharmaceutical world and regulatory, 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.
About me:
I am Neha Parashar, working as a Associate Director in a pharmaceutical company and based in Germany. I am a passionate healthcare professional, an educator, and a mentor.
In this series 'Orphan Drug Development', I will discuss the regaulatory aspects related to orphan drugs.
Channel Introduction- Welcome to PharmaCamp • Welcome to PharmaCamp ...
Series 1 -Regulatory Learnings | Investigational New Drug (IND) Application
• Regulatory Learnings |...
Series 2-Regulatory Shorts
• Regulatory Shorts
Series 3-EU Marketing Authorisation
• EU Marketing Authorisa...
Series 4-Dare to Lead with Neha | An Interview Series with Pharma Leaders
• Dare To Lead - An Inte...
LinkedIn: / neha-parashar
LinkedIn Articles on various Regulatory Topics:
1. Regulatory Pathways for Expedited Access of Medicines / regula. .
2. Step-wise Regulatory approach for the Paediatric drug Development / step-w. .
3. Designing the Global Regulatory Strategy for the Development of Orphan Medicinal Products
/ design. .
4. Step wise approach for Quality Risk Management (QRM) in pharmaceutical industries / step-w. .
5. Step-wise regulatory approach for the assessment of process related impurities in biological products / step-w. .
6. Step-wise approach for sterilisation package preparation in regulatory dossiers for biologicals and other liquid sterilised products / step-w. .
7. Step-wise approach for regulatory risk assessment of adventitious agents in biologicals products / step-w. .
8. Five Step Approach to Assess Equivalency Requirements of Topical Products / five-s. .
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: 14
@nileshbawane842
@nileshbawane842 Жыл бұрын
Nice Neha.. Very much Informative
@pharmacamp
@pharmacamp Жыл бұрын
Thanks Nilesh
@vrushabpipada5346
@vrushabpipada5346 Жыл бұрын
Great informative... 👍👍👍
@pharmacamp
@pharmacamp Жыл бұрын
Thanks Vrushab
@ankurgeete1235
@ankurgeete1235 Жыл бұрын
Good job👏
@pharmacamp
@pharmacamp Жыл бұрын
Thank you :-)
@arpitjaiswal272
@arpitjaiswal272 Жыл бұрын
As always very informative Neha....Keep it up..
@pharmacamp
@pharmacamp Жыл бұрын
Thanks Arpit:-)
@roxananikoui3810
@roxananikoui3810 3 ай бұрын
Hi Neha- Do you have slide deck to provide for your presentations?
@arunjakhar8946
@arunjakhar8946 Жыл бұрын
Informative and crisp👍. Kindly also mention examples and recent advances if any. Thank You.
@pharmacamp
@pharmacamp Жыл бұрын
Thanks Arun
@shivdwivedi2807
@shivdwivedi2807 Жыл бұрын
Priority review is expedited review process within lesser than standard time to give approval to any life saving or in demand drugs ..one of the examples is Orphan drug
@pharmacamp
@pharmacamp Жыл бұрын
That's correct
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