Drug Device Combination Products | Episode 06 - How to Select Notified Body in EU?

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 '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 with Neha | Regulato...   Series 1 -Regulatory Learnings | Investigational New Drug (IND) Application    • Regulatory Learnings | Investigational New...   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 With Ph...   Series 5-Orphan Drug Development    • Orphan Drug Development   Series 6-Drug Device Combination Products    • Drug Device Combination Products   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 #NotifiedBody #NBopinionSteps #CombinationProducts #EuropeanRegulations #HealthcareEurope #MedicalDevices #NBguidelines #CombinationProductsEU #MedicalRegulations #EUmedicalstandards