Orphan Drug Development | Episode 04 - How to get Orphan Drug Designation in European Union | DRA

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 TH-cam 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 • 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...
Series 5-Orphan Drug Development
• Orphan Drug Development
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.

[@nileshbawane842]

Nice one .. Crystal clear.. Waiting for next video

[@pharmacamp]

Thanks Nilesh 😊

[@ThePhani9999]

Thanks neha for sharing valuable information

[@pharmacamp]

Thanks Phani

[@arpitjaiswal272]

As always,very informative

[@pharmacamp]

Thanks Arpit

[@LearnPharma480]

Good evening mam

[@narasimhamurthykaki1938]

Medam, please suggest me any book on regulatory affairs to understand easily