Find the following links for free online Courses, which I have mentioned in youtube @ educational pharma channel, if not see the video do see it, few interview suggestions also have given-
Broadly divided so, as below, whatever available free important content and courses I have collected-
One must know the basic names of various Regulatory authorities of few countries as mentioned in the below image (especially before going to the (Regulatory Affairs) RA interview.
RA market size-based classification, as in below-
I know it's not visible to you, however, kept @ the bottom you can see there-
1. INDIA (DCGI)
1st checkout youtube 12 classes-
Title-
Regulatory requirements for medical devices and IVD (invitro diagnostic) in India (all 12 classes)
or click below link
In NPTEL website National Programme on Technology Enhanced Learning
2. EU (European Union)-MHRA (online certification course)
During this lockdown, online platforms providing @very less cost, few valuable courses, useful for those who have just entered RA of Medical devices or anyone who wants to know about Medical devices
Practical Regulatory Affairs 2020 - European Medical Devices
Udemy check out few other courses of Medical Device, for info. Only(not for student recommended)
For Students/freshers/ or anyone
Easy Medical device
Note:
I would recommend all fellow RA professionals who are into Medical device to listen to Mr Monir's Podcast he is the founder of easy medical device a working Regulatory professional, in his podcast from various regions experienced people come and talk about the practical experiences and challenges, very useful to remain updated and skillful.
subscribe to his youtube channel too.
3. FDA (for drug, device, IVD)
Lot's of content available, however few courses with no credit certification courses are available in the following link
click- Human Drug Approval and Post-marketing then click new drug then click the module home button (at the left corner of the slide), on left side click- ROLE OF OFFICE OF NEW DRUGS, then begin Booton go through the modules and do Q&A for certification, similarly go through the left side topics one by one in below picture with the same procedure as told before..
INTRODUCTION TO FDA HUMAN DRUG REVIEW AND APPROVAL BASICS
For basic Knowledge -
Drug Application and Approval Process - "Questions and Answers
Explore this link too (Student/ working professional)
CTD- for drug same for USA & EU
Note: just for knowledge this CTD link provided, every RA interviewer will ask at least 1 or 2 questions on it or maybe everything on it, based on the requirement & company profile (formulation company). So one must prepare well on this.
Just know the overview of what all is there in a module, what Module 1 is or 2 etc have a rough idea, 1st. In upcoming videos, I will try to simplify it for you whenever possible.
4. UKMHRA (Medical device only found) for anyone (student/fresher/professional)
5. BONUS (if any working professional needs QMS free course)-
ISO 13485:2016 - Quality Management Systems for Medical Devices
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