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Orphan Drug Development | Episode 06 - USFDA vs EMA : Orphan Drug Designation | Regulatory Affairs

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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 YouTube 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 regulatory aspects related to orphan drugs.

Channel Introduction- Welcome to PharmaCamp https://youtu.be/Rpvbzrsuu64

Series 1 -Regulatory Learnings | Investigational New Drug (IND) Application
https://www.youtube.com/playlist?list=PLUODfmL8lrjgrRlxXPEDEjk1Q-kLYbWDi

Series 2-Regulatory Shorts
https://youtube.com/playlist?list=PLUODfmL8lrjikBaxoC3ZBhJAkqSi_35hb

Series 3-EU Marketing Authorisation
https://www.youtube.com/playlist?list=PLUODfmL8lrjht2qSmHqo6mpU8zUGPGAec

Series 4-Dare to Lead with Neha | An Interview Series with Pharma Leaders
https://www.youtube.com/playlist?list=PLUODfmL8lrjizUlQEQimDWkDGTSh0z2gg

Series 5-Orphan Drug Development
https://www.youtube.com/playlist?list=PLUODfmL8lrjh3ZZbsjI3rEdod2mFZvO__


LinkedIn: http://linkedin.com/in/neha-parashar
LinkedIn Articles on various Regulatory Topics:
1. Regulatory Pathways for Expedited Access of Medicines https://www.linkedin.com/pulse/regula...
2. Step-wise Regulatory approach for the Paediatric drug Development https://www.linkedin.com/pulse/step-w...
3. Designing the Global Regulatory Strategy for the Development of Orphan Medicinal Products
https://www.linkedin.com/pulse/design...
4. Step wise approach for Quality Risk Management (QRM) in pharmaceutical industries https://www.linkedin.com/pulse/step-w...
5. Step-wise regulatory approach for the assessment of process related impurities in biological products https://www.linkedin.com/pulse/step-w...
6. Step-wise approach for sterilisation package preparation in regulatory dossiers for biologicals and other liquid sterilised products https://www.linkedin.com/pulse/step-w...
7. Step-wise approach for regulatory risk assessment of adventitious agents in biologicals products https://www.linkedin.com/pulse/step-w...
8. Five Step Approach to Assess Equivalency Requirements of Topical Products https://www.linkedin.com/pulse/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.

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