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 KZfaq 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 Decentralised Procedure (DCP) and Mutual Recognition Procedure (MRP)?
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 | ...
Series 3-EU Marketing Authorisation
What are the Steps and Timelines for Centralised Procedure at EMA? • EU Marketing Authorisa...
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.