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| Name | EU Marketing Authorisation | What are the Steps and Timelines for Centralised Procedure at EMA?| DRA |
| Video Uploader | Video From PharmaCamp |
| Upload Date | This Video Uploaded At 08-10-2022 10:03:53 |
| Video Discription | 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 video, we will discuss - What are the Steps and Timelines for Centralised Procedure (CP) at EMA? Channel Introduction- Welcome to PharmaCamp https://youtu.be/Rpvbzrsuu64 Series 1 -Regulatory Learnings | Investigational New Drug (IND) Application What is Clinical Trial? https://youtu.be/uAUXEsAC23o What is Investigational New Drug (IND) Application https://youtu.be/NTOtI7HfE9I Step-wise Approach for Investigational New Drug (IND) Application https://youtu.be/x0EMVIeh86Y Step 1: How to prepare the Regulatory Strategies for IND Application?https://youtu.be/29eTzqZ5fqQ Step 2: What is Target Product Profile (TPP)? https://youtu.be/gB3K3j7Wg2s Step 3: Meetings with USFDA (Part 1) https://youtu.be/l7Mm-yOVCE0 Step 3: What are the Types of USFDA meetings (Part 2)? https://youtu.be/3xpAkMR6Hlk Step 3: What are the Steps for Meetings with USFDA (Part 3)? https://youtu.be/3YY1KZ8SRq0 Step 3: 10 Tips For Preparation of Successful USFDA Meeting (Part 4)? https://youtu.be/0gO4F6HVE9Y Step 4: What content do we include in IND application (Part 1)? https://youtu.be/o_wWVsVCJxk Step 4: Types of USFDA forms for IND application (Part 2)?https://youtu.be/E0O_bR6RYak Step 5: How to submit an Investigational New Drug (IND) application to USFDA? https://youtu.be/VkIvkpPsv2Y Step 6: How does USFDA review an Investigational New Drug (IND) application? https://youtu.be/-J8TsJ5CluA Step 6: How does USFDA review an Investigational New Drug (IND) application (Part 2)? https://youtu.be/ZX7hSZKB_vw Step 7: How are Clinical Trials Registered in USA?https://youtu.be/v4NjxO172LQ Step 8: How to do IND Life Cycle Management? https://youtu.be/b8_MLwj0m0k Step 9: Completion of Clinical Trial and Ending an IND. https://youtu.be/_-CE0lfa6eM Series 2-Regulatory Shorts Regulatory Shorts#1 | Vaccines Approval | Expanded Access vs Emergency Use Authorization (EUA) vs “Off-Label” Use. https://youtu.be/y9e-aWldjMw Regulatory Shorts#2 | DSUR vs PSUR | Safety Reports Regulatory Shorts#3 |Data Lock Point, International Birth Date, Development International Birth Date. https://youtu.be/Kr4ivc0iwdc Regulatory Shorts#4 | Orange Book vs Purple Book. https://youtu.be/yjglU9IiskM Regulatory Shorts#5| Side Effect vs Adverse Drug Reaction vs Adverse Event. https://youtu.be/0xJSR5EBmMU Regulatory Shorts#6 | Global Expedited Regulatory Pathways. https://youtu.be/HRxkJi-n9tI Regulatory Shorts#7 | Patent vs Data Exclusivity vs Market Exclusivity. https://youtu.be/a8CRsImTiyY Regulatory Shorts#8 | How to get Marketing Authorisation in European Union (EU)?. https://youtu.be/Km9KOvRpBRM LinkedIn: http://linkedin.com/in/neha-parashar LinkedIn Articles on various Regulatory Topics: 1. Regulatory Pathways for Expedited Access of Medicines https://www.linkedin.com/pulse/regula... 2. Step-wise Regulatory approach for the Paediatric drug Development https://www.linkedin.com/pulse/step-w... 3. Designing the Global Regulatory Strategy for the Development of Orphan Medicinal Products https://www.linkedin.com/pulse/design... 4. Step wise approach for the Quality Risk Management (QRM) in pharmaceutical industries https://www.linkedin.com/pulse/step-w... 5. Step-wise regulatory approach for the assessment of process related impurities in biological products https://www.linkedin.com/pulse/step-w... 6. Step-wise approach for sterilisation package preparation in regulatory dossiers for biologicals and other liquid sterilised products https://www.linkedin.com/pulse/step-w... 7. Step-wise approach for regulatory risk assessment of adventitious agents in biologicals products https://www.linkedin.com/pulse/step-w... 8. Five Step Approach to Assess the Equivalency Requirements of Topical Products https://www.linkedin.com/pulse/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. |
| Category | Education |
| Tags | RegulatoryAffairs | Regulatory | Regulation | CMC | ClinicalTrial | Clinical | ClinicalResearch | Pharma | Pharmacy | USFDA | EMA | ICH | Healthcare | pharmaceutical |
