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. |