Drug Device Combination Products | Episode 03-Regulatory Procedure:Combination Products in EU Part-1

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PharmaCamp

PharmaCamp

Күн 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 'Drug Device Combination Products', I will discuss the regulatory aspects related to Combination products.
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.
#CombinationProducts
#DrugDevice
#RegulatoryProcedure
#EURegulations
#HealthcareIndustry
#Innovation
#MedicalDevices
#EUCompliance
#Pharmaceuticals
#MedicalTechnology

Пікірлер: 6
@ankurgeete1235
@ankurgeete1235 Жыл бұрын
Excellent information 👌
@pharmacamp
@pharmacamp Жыл бұрын
Thank you :-)
@nileshbawane842
@nileshbawane842 Жыл бұрын
Nice Neha...very much informative
@pharmacamp
@pharmacamp Жыл бұрын
Thanks Nilesh
@user-dv9fb5wn7p
@user-dv9fb5wn7p Жыл бұрын
You have to pay notified bodies to register products. Great series of video's, very useful!
@pharmacamp
@pharmacamp Жыл бұрын
Thanks
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