LIVE_Pharmaceutical Regulatory Affairs

Pharmaceutical Regulatory Affairs

Prof. Prakash V Mallya
Director and Professor
Krupanidhi College of Pharmacy

TOTAL WORK EXPERIENCE
Pharma Industry - 35 Years + Academic Teaching & Training -10 Years

PHARMA - INDUSTRY EXPERIENCE
Total 35 + Years of Pharma Industry Experience in International Marketing, Regulatory Affairs, Medico-Marketing, Bio/Clinical Studies, Product Management, Packaging Development, Field & Plant Training. Conducted International Audits and Inspections.
Launched New Pharmaceutical Divisions and New Pharmaceutical Products in India and World Markets.
Visited more than 60 countries of the world including USA, Canada, European Countries, Southern African Countries, Latin American Countries, South East Asia, SARC Countries and recently the Gulf and Middle East Countries.
Experience in Organising Global Exhibitions, Event Management, Medical Seminars, Symposiums & CME’s , WebSite Development, Corporate Films.

PRESENTLY ACADEMIC TEACHING & TRAINING EXPERIENCE
10 Years Academic Teaching Experience as Director & Professor at Krupanidhi College of Pharmacy. Established CPPA- Center for Pharmaceutical Professional Advancement. Center for Finishing School and Soft Skills Training, Employability Skills. Industry –Academia Cell, Projects, International Students Career Cell.

About the Topic: Regulatory Affairs- RA, in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities and Ministry of Health across the world. It is mainly involved in the registration of the API, Finished Pharmaceuticals, Medical Device etc in India and Global countries prior to their marketing.
The Regulatory Affairs- RA Department, Act as a liaison with Global Regulatory Agencies and Ministry of Health for Product Registration . It Involves Preparation of organized and scientifically valid Technical DOSSIERS which adheres and is compliant with all the applicable cGMP, ICH, GCP, GLP guidelines, regulations and laws. Providing expertise and regulatory intelligence in translating regulatory requirements into practical workable plans. Advising the companies on regulatory aspects and climate that would affect their proposed activities. Apart from the above main roles, there are various other roles which Regulatory Affairs professionals play.
Proficiency in Regulatory Affairs has high Career Prospects for budding Pharmacy Students.

[mandel_]

Thank you so much sir.
I am student from Yemen. I just got master pharmacy from India.
You gave me the Enthusiasm, to start to read more and more about drug regulatory affairs.
I just finished my master pharmacy Pharmaceutics.
Once of my subjects that i took is regulatory affairs. But i don't know to which extent the importance of it.
Again thankful and grateful for you

[vijayakumarganapathysankar]

very nice session and quite compreshensive..thanks a lot for the organizers

[gargitarafdar]

Pretty elaborate. A very detailed peek at the RA in Pharmaceutical industry. Sharing this one.

[ramchandrasuryavanshi]

Thank you so much sir, as u have enlightenment us from where we unaware and making us stronger with regulatory affairs knowledge.

God bless you sir

[poojag]

Excellent video sir. Thank you so much.

[amrutha]

Thank you sir;so informative for my carrier

[harikrishna]

Thank you very much Sir, we receive nice information about regulatory affairs, and one more Sir, could we expect genotoxic impurities, assessment and its characterization and controls too. Once again thank you very much Sir

[sudhandhiravanithachandran]

I watched your session it is very useful please keep give lot of sessions like this sir, please put QA activities with examples please sir.thanks sir.we are awaiting for your sessions.🙏

[uttarabhomkar]

Thank you for enlightening us with the overview of Regulatory Affairs 🙏.

[rupenddraas]

Thank you sir
Very experienced approach of RA.
Found it useful

[alonnasworld]

Very much informative. Thank you so much

[enakollasucharitha]

Thank you so much sir, it helped me a lot

[kicksiddik]

Thank you Sir, which book 📖 is most good for RA?

[abhishekpednekar]

Regulatory affairs vs API synthesis which will be paid higher for experience person.