Regulatory Shorts#8 | How to get Marketing Authorisation in European Union (EU)?

Regulatory Shorts#8 | How to get Marketing Authorisation in European Union (EU)? | Drug Registration

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Жыл бұрын

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 - How to get Marketing Authorisation in European Union (EU)?
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 | ...
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.

Пікірлер: 40

@shyammahajan4098 Ай бұрын

Very Informative! Thanks Neha

@prashant71 Жыл бұрын

Sunset Clause: A legal provision stating that the marketing authorisation of a medicine will cease to be valid if the medicine is not placed on the market within three years of the authorisation being granted or if the medicine is removed from the market for three consecutive years.

@pharmacamp Жыл бұрын

Right Answer. Well done😊

@nileshbawane842 Жыл бұрын

Great Neha about clarification between MRP & DCP

@pharmacamp Жыл бұрын

Thanks Nilesh. I am glad that it was helpful:-)

@mchitra2165 Жыл бұрын

Excellent presentation!! Very helpful for non-regulatory professionals like me:-)

@pharmacamp Жыл бұрын

Thanks M Chitra. I am happy to know this:-)

@ranjithjadhav8032 Жыл бұрын

Good work... Keep it up.. best luck

@pharmacamp Жыл бұрын

Thanks Ranjit

@Vmkavitha Жыл бұрын

u made my day mam....I never understand MA this much easy than ur presentation....thanks a lot...expecting and requesting more content for LCMs and post approvals for EU

@pharmacamp Жыл бұрын

Thanks Kavitha. I am very glad to know that the video content is helping :-)

@harshitamittal8539 Жыл бұрын

I was confused with these EU procedures..now all cleared thank you mam

@pharmacamp Жыл бұрын

Thanks Harshita. I am happy to know that this video helped to clarify.

@ronitahile630 Жыл бұрын

Very Useful Information. Thank You Ma'am.

@pharmacamp Жыл бұрын

Thanks Ronit

@arpitjaiswal272 Жыл бұрын

Very informative video Neha....keep it up....

@pharmacamp Жыл бұрын

Thanks Arpit.

@sambhajimasal4248 Жыл бұрын

Thank You ,mam!

@pharmacamp Жыл бұрын

You're welcome.

@stutikamane4435 Жыл бұрын

Critical information in simple way Can you please explain EU variation application and timelines procedure

@pharmacamp Жыл бұрын

Thanks Stutika.Yes, I will cover the EU variation topic in one of the future videos.

@siddheshsanghavi6128 Жыл бұрын

Thank mam for the video but I want all the detail information about the submission process and documents which has to be submit for the veterinary drug in EU

@nizemshaheenshaik603 Жыл бұрын

Tq u so much ma'am..it was much useful. 🥰

@pharmacamp Жыл бұрын

Thank you:-)

@harishasnayak5249 Жыл бұрын

Very good video

@pharmacamp Жыл бұрын

Thanks Harisha

@Vinay-cg1ik Жыл бұрын

Such a helpful video, Madam. Can you please guide me to get RA job in the foreign countries?

@nileshbawane842 Жыл бұрын

Kindly upload videos, regarding approval process timeline in detailed manner for all procedure

@pharmacamp Жыл бұрын

Sure Nilesh. I will cover this topic in the next upcoming videos.

@60anushkashinde99 9 ай бұрын

Mam do u have any presentation regarding EU whole regulatory process

@deepakjena2332 Жыл бұрын

Madam we are planning to go for EU approval, Can you suggest from the beginning what steps we have to follow.

@singh_deep2818 Жыл бұрын

Pls. Make a detailed video on CMC authoring part.

@pharmacamp Жыл бұрын

Sure, I will add this topic to the future video list.

@singh_deep2818 Жыл бұрын

@@pharmacamp will be awaiting for that. Thanks a ton🙏

@AeshaPatel-gz6io 2 ай бұрын

Which procedure is applicable for Abbreviated new drugs (Combination drugs) Application. I want to take Marketing authorization for all 27 countries in EU. In this case which procedure is applicable?

@sbhavan1002 Жыл бұрын

If one is ready to get MA for nanopharmaceuticals or nano drugs, which is MA mostly used for approval

@pharmacamp Жыл бұрын

It depends on what types of drug/therapy that nanomaterial contains. The drug products manufactured using nanotechnology are subject to the optional centralized authorization procedure. However, if the nanomaterials have any drugs that are covered under mandatory scope for eg HIV, Autoimmune dysfunctions, advance therapy etc.,then this will be covered by mandatory centralised procedure.

@sbhavan1002 Жыл бұрын

@@pharmacamp Thank you Mam

@snehalbikkad1588 Жыл бұрын

What is sunset clause?

@pharmacamp Жыл бұрын

A sunset clause for marketing authorization in the European Union (EU) is a time limit set for the validity of a granted marketing authorization for a particular product. It means that after a certain period of time, the authorization will expire or "sunset" if not renewed or extended.