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

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

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 regaulatory aspects related to orphan drugs.

Channel Introduction- Welcome to PharmaCamp    • Welcome to PharmaCamp with Neha | Reg...  

Series 1 -Regulatory Learnings | Investigational New Drug (IND) Application
   • Regulatory Learnings | Investigationa...  

Series 2-Regulatory Shorts
   • Regulatory Shorts  

Series 3-EU Marketing Authorisation
   • EU Marketing Authorisation  

Series 4-Dare to Lead with Neha | An Interview Series with Pharma Leaders
   • Dare To Lead - An Interview Series Wi...  

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.

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