EU Marketing Authorisation | What are the Steps and Timelines for Centralised Procedure at EMA?| DRA
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- Опубліковано 8 лют 2025
- 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 UA-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 video, we will discuss - What are the Steps and Timelines for Centralised Procedure (CP) at EMA?
Channel Introduction- Welcome to PharmaCamp • Welcome to PharmaCamp ...
Series 1 -Regulatory Learnings | Investigational New Drug (IND) Application
What is Clinical Trial? • What is Clinical Trial...
What is Investigational New Drug (IND) Application • What is Investigationa...
Step-wise Approach for Investigational New Drug (IND) Application • Step-wise Approach for...
Step 1: How to prepare the Regulatory Strategies for IND Application? • Step 1: How to prepare...
Step 2: What is Target Product Profile (TPP)? • Step 2: What is Target...
Step 3: Meetings with USFDA (Part 1) • Step 3: Meetings with ...
Step 3: What are the Types of USFDA meetings (Part 2)? • Step 3: What are the T...
Step 3: What are the Steps for Meetings with USFDA (Part 3)? • Step 3: What are the S...
Step 3: 10 Tips For Preparation of Successful USFDA Meeting (Part 4)? • Step 3: 10 Tips For Pr...
Step 4: What content do we include in IND application (Part 1)? • Step 3: 14 Tips to fol...
Step 4: Types of USFDA forms for IND application (Part 2)? • Step 4: Types of USFDA...
Step 5: How to submit an Investigational New Drug (IND) application to USFDA? • Step 5: How to submit ...
Step 6: How does USFDA review an Investigational New Drug (IND) application? • Step 6: How does USFDA...
Step 6: How does USFDA review an Investigational New Drug (IND) application (Part 2)? • Step 6: How does USFDA...
Step 7: How are Clinical Trials Registered in USA? • Step 7: How are Clinic...
Step 8: How to do IND Life Cycle Management? • Step 8: How to do IND ...
Step 9: Completion of Clinical Trial and Ending an IND. • Step 9: Completion of ...
Series 2-Regulatory Shorts
Regulatory Shorts#1 | Vaccines Approval | Expanded Access vs Emergency Use Authorization (EUA) vs “Off-Label” Use. • Regulatory Shorts#1 | ...
Regulatory Shorts#2 | DSUR vs PSUR | Safety Reports
Regulatory Shorts#3 |Data Lock Point, International Birth Date, Development International Birth Date. • Regulatory Shorts#3 |D...
Regulatory Shorts#4 | Orange Book vs Purple Book. • Regulatory Shorts#4 | ...
Regulatory Shorts#5| Side Effect vs Adverse Drug Reaction vs Adverse Event. • Regulatory Shorts#5| S...
Regulatory Shorts#6 | Global Expedited Regulatory Pathways. • Regulatory Shorts#6 | ...
Regulatory Shorts#7 | Patent vs Data Exclusivity vs Market Exclusivity. • Regulatory Shorts#7 | ...
Regulatory Shorts#8 | How to get Marketing Authorisation in European Union (EU)?. • Regulatory Shorts#8 | ...
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 the 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 the 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.
Nice Neha, best research and very professional way of explanation, Thank you. Will wait for your videos on ATMPs, and CAT !..... Greetings from London.
Thank you :-)
Very good explained
Explained Very well in lucid language.
Thank you Neha. There are Very few Or no channels covering Pharma regulatory Segment from filing perspective.
I would request you to please make one video on regulatory job options in Europe, US, UK etc. please explain along with salary details.
Thank you. Keep it up.
Thanks Avinash. I am very happy to know this 😊. Sure will cover more such topics in future.
can you please provide the link of your previous video which you are talking in this video; very wonderful explanation; thankyou so much!!!
Wonderful explanation mam.
It's easy to understand and informative...
Thanks Mrunali
Amazing explanation Mam..Thank You
Thanks Sneha
Precise and complete Information
Thanks Stutika
Very good explanation.
Thnks for the information
Amazing information.
Thanks Prashant
Excellent explanation madam
Thanks
Usefull information
Excellent
Thanks Vinay
Useful
Can you make video on business development and licensing terms
Ma'am how and where we apply for DRA in foreign countries
For veterinary products we want to go through cp is it compulsory?
Thank you for the information, I have learnt very much info in a few minutes. can u give me MHRA link or pathway for MA submission?
Please make a video on variations
Sure Sandeep. I have this topic in the list.
Thanks mam, I am also a regulatory professional and working on EU and South African markets. Your videos are very helpful. Do you also provide the webinars?
I am happy to know that videos are helpful. Yes the webinar is in plan. Will keep posted.
@@pharmacamp really amazing, keep posting😊😊