EU Marketing Authorisation | What are the Steps and Timelines for Centralised Procedure at EMA?| DRA

Описание: 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    • Welcome to PharmaCamp with Neha | Regulato...  

Series 1 -Regulatory Learnings | Investigational New Drug (IND) Application
What is Clinical Trial?    • What is Clinical Trial? | Regulatory Learn...  
What is Investigational New Drug (IND) Application    • What is Investigational New Drug (IND) App...  
Step-wise Approach for Investigational New Drug (IND) Application    • Step-wise Approach for  Investigational Ne...  
Step 1: How to prepare the Regulatory Strategies for IND Application?   • Step 1: How to prepare the Regulatory Stra...  
Step 2: What is Target Product Profile (TPP)?    • Step 2: What is Target Product Profile (TP...  
Step 3: Meetings with USFDA (Part 1)    • Step 3: Meetings with USFDA (Part 1) | Reg...  
Step 3: What are the Types of USFDA meetings (Part 2)?    • Step 3: What are the Types of USFDA Meetin...  
Step 3: What are the Steps for Meetings with USFDA (Part 3)?    • Step 3: What are the Steps for Meetings wi...  
Step 3: 10 Tips For Preparation of Successful USFDA Meeting (Part 4)?    • Step 3: 10 Tips For Preparation of Success...  
Step 4: What content do we include in IND application (Part 1)?    • Step 3: 14 Tips to follow during and after...  
Step 4: Types of USFDA forms for IND application (Part 2)?   • Step 4: Types of USFDA forms for IND appli...  
Step 5: How to submit an Investigational New Drug (IND) application to USFDA?    • Step 5: How to submit an Investigational N...  
Step 6: How does USFDA review an Investigational New Drug (IND) application?    • Step 6: How does USFDA review an Investiga...  
Step 6: How does USFDA review an Investigational New Drug (IND) application (Part 2)?    • Step 6: How does USFDA review an Investiga...  
Step 7: How are Clinical Trials Registered in USA?   • Step 7: How are Clinical Trials Registered...  
Step 8: How to do IND Life Cycle Management?    • Step 8: How to do IND Life Cycle Managemen...  
Step 9: Completion of Clinical Trial and Ending an IND.    • Step 9: Completion of Clinical Trial and E...  

Series 2-Regulatory Shorts
Regulatory Shorts#1 | Vaccines Approval | Expanded Access vs Emergency Use Authorization (EUA) vs “Off-Label” Use.    • Regulatory Shorts#1 | COVID-19 Vaccine | E...  
Regulatory Shorts#2 | DSUR vs PSUR | Safety Reports
Regulatory Shorts#3 |Data Lock Point, International Birth Date, Development International Birth Date.    • Regulatory Shorts#3 |Data Lock Point, Inte...  
Regulatory Shorts#4 | Orange Book vs Purple Book.    • Regulatory Shorts#4 | Orange Book vs Purpl...  
Regulatory Shorts#5| Side Effect vs Adverse Drug Reaction vs Adverse Event.    • Regulatory Shorts#5| Side Effect vs Advers...  
Regulatory Shorts#6 | Global Expedited Regulatory Pathways.    • Regulatory Shorts#6 | Global Expedited Reg...  
Regulatory Shorts#7 | Patent vs Data Exclusivity vs Market Exclusivity.    • Regulatory Shorts#7 | Patent vs Data Exclu...  
Regulatory Shorts#8 | How to get Marketing Authorisation in European Union (EU)?.    • Regulatory Shorts#8 | How to get Marketing...  
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.