Drug Device Combination Products | Episode 06 - How to Select Notified Body in EU?
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- เผยแพร่เมื่อ 24 มิ.ย. 2024
- 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 'Drug Device Combination Products', I will discuss the regulatory aspects related to Combination products. This comprehensive guide will walk you through the steps for a Notified Body (NB) opinion on Combination Products in Europe. You'll learn the process, the essentials, and the potential pitfalls to avoid. We will delve into the specifics, from initial planning stages to the final approval, making this complex procedure more accessible to you. With updates on the latest regulations and expert insights, this video will equip you with the knowledge to navigate this complex terrain confidently. We will debunk common misconceptions and reveal lesser-known facts, providing a clear roadmap for the successful introduction of your combination product into the European market.
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
Series 6-Drug Device Combination Products
• Drug Device Combinatio...
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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#DrugDevice
#RegulatoryProcedure
#EURegulations
#HealthcareIndustry
#Innovation
#MedicalDevices
#EUCompliance
#Pharmaceuticals
#medicaltechnology
#NotifiedBody
#NBopinionSteps
#CombinationProducts
#EuropeanRegulations
#HealthcareEurope
#MedicalDevices
#NBguidelines
#CombinationProductsEU
#MedicalRegulations
#EUmedicalstandards
Very informative and innovative. Good and all the best
Thanks a lot
Very helpful. Keep doing what you do
Thank you:-)
Nice Neha.. Very much informative.. Keep up the good work continue..
Need to know more about Health Technology Assessment in EU. If possible, could you please make some videos and share the knowledge.
Thanks Nilesh 😊. I will add this topic to one of the future videos
Thank's Neha for your attention... waiting for the same...
Thanks in advance