Basic Concepts of Pharmaceutical Regulatory Affairs | Drug Regulatory Affairs Interview Questions

Рет қаралды 65,067

Күн бұрын

In this lecture, we are discussing general concepts of pharmaceutical regulatory affairs or frequently asked interview questions of drug regulatory affairs.
The following topics are discussed in this lecture:
1. Drug Development/Approval Process
2. What is Regulatory Affairs and Roles of Regulatory Affairs Professionals?
3. Regulatory Authorities of Different Country
4. Basic Terminologies (like Generic drug products, IND, NDA, ANDA).
5. Potential U.S. Regulatory Pathways
6. DMF (Drug master file) & its types
7. Orange Book, ICH, 180-day exclusivity
8. Types of ANDA (Abbreviated new drug application) Filing
9. CTD and its Modules
10. Marketing Authorization Application (MAA)
11. Active substance master file (ASMF)
12. Marketing Authorization Procedure for Pharmaceuticals in EU
13. Procedures for Drug Approval in EU
14. Difference between NDA (New drug application) & ANDA
My other videos related to Pharmacy:
Introduction to General Pharmacology | Basics of Pharmacology | Pharmacy | NEET PG | Part 1 | Hindi
• Introduction to Genera...
Routes Of Drug Administration Of General Pharmacology For Pharmacy, Medical | PART 2 | Hindi
• Mastering the Differen...
For more videos please subscribe to @education tricks 99 and don't forget to hit the bell icon for latest notification.
Thanks for watching this video !!!!!!!!

Пікірлер: 61

@muazhababa6858 Жыл бұрын

very Helpful Sir..all respect to your efforts

@ramlalkumar9136 10 ай бұрын

TQ so much sir ..your explanation is wonderful

@mariarauf427 Жыл бұрын

Indeed, very helpful content!!

@amrutha2607 Жыл бұрын

Thank you so much;it’s help me a lot

@aishashaik851 Жыл бұрын

Excellent explanation thanks a lot..

@aditideshpande9122 Жыл бұрын

Thank you sir, helpful session 👍🏻

@mayuripatil1777 Жыл бұрын

wow . Amazing lecture sir in very simple language and concept . thanku so much 🙏🥰

@Sachin-fr4qb Жыл бұрын

Your welcome

@sulakshamunnolli348 7 күн бұрын

Excellent 👌

@swarupa19 2 жыл бұрын

Such a beautiful presentation with a lot of information

@EducationTricks99 2 жыл бұрын

Thanks

@rohitmarathe295 8 ай бұрын

Nice information#live long brother....

@vasugaddam3748 Жыл бұрын

Excellent sir,

@krishmodi8591 2 жыл бұрын

Thank you sir for this.. one of the most informative video

@Sachin-fr4qb Жыл бұрын

Your welcome

@nooshafarinhirad9774 2 жыл бұрын

Many thanks it was a great help for me ...specially for registration in EU

@Sachin-fr4qb Жыл бұрын

Your welcome

@arunimsharma2787 11 ай бұрын

Great explanation

@user-bb4qe1hd4p 5 ай бұрын

Very nice explanation 👌

@rajugopale4651 9 ай бұрын

Nicely explained...

@prafulllokhande8059 2 жыл бұрын

Nice Information 👍

@jindabaadkisani9534 Жыл бұрын

Respected Sir.. Can you suggest me any reference book of drug regulatory affairs to clear my concepts.. your presentation is really amazing.. thanku so much for giving such a valuable information 🙏🙏

@rohanmagdum3969 2 жыл бұрын

Please do more videos like that on Pharmacovigilance and Clinical Research topic

@utkarshwankhade1392 Жыл бұрын

good job sir That was so informative one ! Also plz make a video on us dossier submissions in detailed

@kanquona Жыл бұрын

So well described. Thanks for sharing this. Kindly make videos on dossier preparation and publishing tasks.

@Sachin-fr4qb Жыл бұрын

Thanks sure

@RishabhSharma-wy9qg 9 ай бұрын

Thank you Sir

@prabalyadav7219 2 жыл бұрын

Thank u so much sir fir giving this precious knowledge. Also humble requesting to u sir please make more videos on dra and preparation of dossiers

@Sachin-fr4qb Жыл бұрын

Yes pls stay tuned

@NewLeapEducation 3 ай бұрын

Very nice one

@sonalirawat5650 Жыл бұрын

Well explained! Thanks for sharing👍

@MDMilon-wq8ku 2 жыл бұрын

Thank You so much Sir

@Sachin-fr4qb Жыл бұрын

Your welcome

@rishipahwa3817 2 жыл бұрын

Keep it up brother🙌🔥

@EducationTricks99 2 жыл бұрын

Thank you😇

@mansisingh9919 Жыл бұрын

Hi, does the European procedure for drug approval begin after getting approval from the FDA and completing all clinical trials?

@apurvatripathi1933 Жыл бұрын

Awesome sir but please suggest us for the book

@tanayapawar7912 Жыл бұрын

Can you please provide information about what kind of PG diploma you have done in RA and from which institute? Also it’s duration and other related information?

@nahidansari3473 2 жыл бұрын

quite informative 😁

@EducationTricks99 2 жыл бұрын

Thank you Nahid

@rohanmagdum3969 2 жыл бұрын

Very well presentation sir

@Sachin-fr4qb Жыл бұрын

Thank you

@erapoguanil4708 2 жыл бұрын

Thank you sir good information about regulatory affairs 👍👍

@EducationTricks99 2 жыл бұрын

Your welcome

@krish_krish354 9 ай бұрын

For generic product how they come to know the inovator route of synthesis also. What is route of administration

@sakharesushsnt3594 Жыл бұрын

Good morning sir. Please suggest best class for PGDM in Regulatory affairs .. im from pune.

@matkarmukund2945 Жыл бұрын

Very important information but please try to explain in detail with example if any ...

@deeathseekr5936 Жыл бұрын

Sir what is the starting salary package for regulatory affairs and Is there any institute in Delhi for drug regulatory affairs

@anamac6519 Жыл бұрын

Sir where did you get your pg diploma from? Can you please share some options to get pg diploma/ certification in India?

@rahulpatil-yy2zk Жыл бұрын

Nice video sir your linkindin profile not seen sir

@AmanGupta-kt7dc 2 жыл бұрын

Sir in this field, we have opportunities to go out of country for work purposes??

@Sachin-fr4qb Жыл бұрын

Yes you can go outside India for doing work in regulatory affairs domain there is lot of scope

@anuptambuskar 2 жыл бұрын

In corona outbreak, which one INDA was files? Treatment IND or Emergency USe IND?

@reenimichael9875 Жыл бұрын

Emergency Use IND

@nipurnjain2432 Жыл бұрын

Sir I want to do course in PGDM in Regulatory affairs so where I can do this Like you have done Please guide us. Thank you

@dasambhagyalakshmi5849 9 ай бұрын

Hello sir iam doing M.pharmacy in pharmaceutical analysis iam eligible for Regulatory affairs department course

@vriddhirathi1522 Жыл бұрын

Can you please share this ppt sir

@vishalkumarmishra250 Жыл бұрын

Hello sir can you please give ur any social media platform where I can ask questions to u

@shivamsain6018 2 жыл бұрын

Please Provide pdf.....