Regulatory Affairs Explained Episode 1: FDA, Application Types, Regulatory Pathways & More

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Күн бұрын

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Welcome to the Regulatory Affairs Explained Series! In episode 1 we discuss the Food and Drug Administration (FDA), Application Types, Regulatory Pathways & More!
Time Stamp⏰:
0:00 - 0:29 - Introduction
0:30 - 1:00 - Order The Prepared Graduate Today!
1:01 - 2:16 - What is the FDA?
1:27 - 3:29 - CDER vs CBER
3:30 - 3:57 - What is an IND?
3:58 - 4:34 - What is an NDA/BLA?
4:35 - 5:43 - What is an sNDA/sBLA?
5:44 - 6:07 - Over the Counter Application
6:08 - 7:31 - What is the 505(b)(1) Regulatory pathway?
7:32 - 7:54 - What is the 505(b)(2) Regulatory pathway?
7:55 - 9:15 - What is the 505(j) pathway?
9:16 - 9:53 The importance of Regualtory Strategy
9:54 - 10:24 - Conclusion
To learn more about INDs at the FDA visit this link: www.fda.gov/drugs/types-appli...
To learn more about NDAs at the FDA visit this link: www.fda.gov/drugs/types-appli...
To learn more about biologics (BLAs) at the FDA visit this link: www.fda.gov/vaccines-blood-bi...
There is a lot to learn about regulatory affairs, so make sure you subscribe and turn on post notifications so you don't miss episode 2!
Commonly used acronyms:
FDA - Food and Drug Administration
IND - Investigational New Drug Application
NDA - New Drug Application
BLA - Biologics License Application
sNDA - Supplemental New Drug Application
sBLA - Supplemental Biologics License Application
CDER - Center for Drug Evaluation and Research
CBER - Center for Biologics Evaluation and Research
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#regulatoryaffairs #RegualtoryExplained #FDA

Пікірлер: 46

@DJL2021 Жыл бұрын

I have worked as a scientist for about 15 years and I’m looking into reg affairs … this video was extremely helpful! As you were talking everything started to click and I have notice were my work was contributing. Thank you and I can’t wait to watch all the videos … this career change is looking very possible!

@ghostofday5025 Жыл бұрын

how is being a scientist like?

@jordan19862000 Жыл бұрын

@@ghostofday5025 it is very scientific

@elidyah9558 2 жыл бұрын

Such a great breakdown I recruit regulatory professionals and this has enhanced my market knowledge

@priteshgahine1970 Жыл бұрын

Can you please connect with me Mam. I am interested in Regulatory Affairs, I had done Graduation in Pharmacy. Please provide me your LinkedIn profile link.

@Signedxlisa 2 жыл бұрын

loving these videos. and the beige set!

@SebastianGonzalez-kt8lh 2 жыл бұрын

What a great video! I'm a regulatory affairs coordinator in Guatemala working with generics throughout central and south America, but regulations here are very different and I don't know a lot about FDA pathways, so this was new!

@CocaColeyy 2 жыл бұрын

Yessss I’m excited for this series!

@SL-zn9oh 2 жыл бұрын

This is such an amazing resource! Thank you for providing more context and detail into your day-to-day. I currently work in pharmacovigilance and hope to explore RA in the future. Please keep this series going!

@Lillylinouch 2 жыл бұрын

Thanks for this series As always you rock 🤘🏻 Wish you good luck with the next videos 🤩

@ednankemdi 2 жыл бұрын

Just found you and I’m so excited to watch all of your content! And order your book! Subscribed!

@michellebrazfield6143 2 жыл бұрын

Just found your channel and wanted to share how much I appreciate your videos! Thank you for sharing your knowledge and experience! Subscribed & liked :)

@No.ThatPrettyGirl Жыл бұрын

This was a FABULOUS video. I am so happy I just stumbled upon ur channel. Definitely a new subbie for sure. I've been a Registered Respiratory Therapist for over 22 years and in 2020, I finally finished my MBA-HCM. Besides having a passion to create, develop and drive products to market (mostly class I devices), I've always had an interest in what happens in the "back of the house operations." Sounds like the kind of work you do. Any advice for me as to how to get in the "front door", if you will.? My undergraduate degree is in Cardiopulmonary Science/ Medicine from LSUHSC New Orleans. Still a NOLA girl here. Thank you kindly. I certainly plan to buy ur book and listen to more of ur videos.

@devangmehta2591 5 ай бұрын

You are so thorough in your explanation, thank you

@adetaiye00 2 жыл бұрын

Thanks for Breaking it down

@andie_Jones 2 жыл бұрын

Thank you for all the information

@shwetaravipandey324 2 жыл бұрын

Very well explained !

@Kanatshi 2 жыл бұрын

Hi. thank you for this video. Have you thought of doing a video talking about the resources available to stay up to date with regulatory intelligence? Even videos of the type of training that's ideal for a candidate looking to advance their careers to managerial roles, please?

@ohan301 2 жыл бұрын

Great job Kyyah! At some point can u discuss the differences in RAPS certificates? Thank you!

@sadikajinsi4093 Жыл бұрын

iam working as a regulatory affair pharmacist incharge in one of the drug store uae .during my search for learning more about regulatory in pharmaceutical industry i find out this one.really its very informative .thankyou.

@musicalsoul440 5 ай бұрын

Hi I'm adarsh please provide some information regarding DHA exam please mention some cantact number

@user-ne7yx2tb5o Жыл бұрын

Extremally informative video. Please suggest a book or make a video from Drug Discovery and Development, what Clinical and marketing applications and post clinical Surveillance submission applications are submitted in different countries and how the differ from each other in process and structure. Thanks

@Grace-jb7me 6 ай бұрын

You explained this so well I wish you explained IDEs too😭

@kanainoue8328 7 ай бұрын

Hi Kyyah, thank you for such an interesting and informative RA series! I always enjoy visiting your channel as your videos have always been very helpful with great advice and insight! I have a question: I'm interested in going into HEOR (with no experience) but was offered an RA entry-level role. I know RA and HEOR divisions/teams are slightly related and may work together when exchanging information or putting together reports, etc. but would the RA entry-level experience help me break into the HEOR field later on in my career? Or would I need to start it all over again after this RA role because they're two totally different worlds? (which may take another 2 years before I quit) I'm a bit worried about the timeline because of how long it may take me to actually get my foot into the HEOR door, especially when most of their openings are not entry-level positions and usually require some prior experience. I did some informational interviews, and some people in the field even suggested that I start by doing an internship (even if I already have about 3-4 years of working experience in non-HEOR fields with an MPH degree).

@sbhavan1002 Жыл бұрын

Hi your description was really great . Is the same regulatory pathways applied for nano pharmaceutical. Can you provide which part of 21 cfr includes info on nano pharmaceuticals.

@ethelnankya7723 Жыл бұрын

Hello, any resources you could recommend to learn more about the nitty gritty of regulatory affairs?

@marilynvdbroeck 2 жыл бұрын

Great resource! Will watch this whole series. Is Subpart H a different type of pathway or is it one of the pathways under 505b1?

@marilynvdbroeck 2 жыл бұрын

@@kyabdul I understand! Thanks for the response

@monicaraju9707 4 ай бұрын

Hello I am presently working as a quality technician for a food manufacturing company, with experience in label compliance and designing. I am highly motivated to move to regulatory affairs role and build my expertise in that line. Can you suggest me how do I go about it, what trainings do I take to start off my career in that line relating to food.

@michelle-zp4ef 2 жыл бұрын

Loving your videos 😍 so interesting. I'm very new to regulatory affairs in the pharmaceutical industry (generic) and struggling every day😂 Thank you for this series 😍 Greetings from Germany

@clcascon707 2 жыл бұрын

Thanks for your video ! Um,, Do you have any tips for writing a convincing & persuasive documents? (ex. CTD M2, other submission Files..) I’m a associate level , and.. after working as a RA for more than 2 years, I feel like writing skills are quite important. such as 'how to structure the text' , or 'how to choose the right sentence or pick a right word etc.. I'm curious about your thoughts.

@clcascon707 2 жыл бұрын

@@kyabdul 💖 Thank you so much for your advice , you always show us the right path for beginners like me. It means so much. 😀

@samiaarif8710 11 ай бұрын

Name your book?

@PreColonialSikhi Жыл бұрын

I’m a nurse wanting a nee career. Is this a good career to go into?

@musicalsoul440 5 ай бұрын

Someone can help currently im completing bachelor's degree in pharmacy ,, I'm unable to what should do next ,, I'm also so confused weather choose career in regulatory affairs or become a pharmacist in Dubai

@maryamnabavi759 Жыл бұрын

Hi thanks for your very useful videos, I’m a foreign PharmD pharmacist with experiences in the nanotechnology lab and toxicology one as a researcher in my country. I want to get my foot inside pharmaceutical even with entry level position. What’s the best path to take? Thank you

@selfmadesocial7280 Жыл бұрын

Quality Assurance, Quality Control, or Quality Engineering and Validation. Quality Assurance works with documentation and is involved with Quality Systems. Quality engineering deals with reports, data analysis etc. Validation deals with temperature mapping as example for equipment used in pharmaceutical operations.

@EliZangvil Жыл бұрын

Great video but cannot concentrate because of the background music - how I can I remove it?

@kyabdul Жыл бұрын

Unfortunately it cannot be removed

@PoojaSingh-so6gv 2 жыл бұрын

As I have completed my B.D.S degree,so can I pursue this course??

@pseller4052 Жыл бұрын

@@kyabdul it is a dentistry degree in some countries.

@johnterry6541 2 жыл бұрын

Wow skipped the whole initial meeting part

@jellyo3670 Жыл бұрын

this is for US FDA Regulations? Is this applicable to Canada as well?

@kyabdul Жыл бұрын

Only US FDA. Health Canada Regs we’re not assessed in this serious

@preetymishra6573 2 жыл бұрын

Hey Kyyah I am new to your channel and loving it. I wanted to connect with you on LinkedIn but could not find you. Could you please share a link. Thanks