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pharma regulatory affairs online training

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  • Published date: June 24, 2019
  • Modified date: June 25, 2019
    • Kukatpally, Hyderabad, Andhra Pradesh, India

  Tirumala Sai (TS) Technologies is one of the best Training center in Hyderabad established in 2011.It is promoted by a team of young professionals having vast experience in different domains. Our Team members are well qualified and experienced, also having very good recognition in the industry. We offer a wide array of solutions customized for a range of key verticals and horizontals in the IT industry


We r now starting Regulatory Affairs(RA) training by Real time expert working with TOP MNC, having 12+ yrs of Real time industry exp.


 We offer  regular, Weekend online training.


Plz go through the RA course content below  


Module-1


 Introduction to the profession and its overview Introduction and general overview of pharmaceutical industry Definitions and various deparments in an industry Regulatory Affairs as a profession and its importance Code of Ethics of regulatory profession Functions of Regulatory Affairs Importance of QA and its link with Regulatory affairs Origin of drug development process and filings Importance of Regulatory audits


Module-2


Regulations in Unites States of America About USFDA and their Mission Code of federal regulations Patents and Data exclusivity About NDA, ANDA and other filing processes. About the paragraphs and simulation of judgment’s


Module-3


Regulations in European Countries EU commission EMA including CHMP and CVMP National Authorities of other EU countries Centralized procedure Decentralized procedure Mutual Recognition procedure


Module-4


 Regulations in Other countries and Dossiers DMF & CTD Differences in EU & US Regulations Regulations in Canada and its filing process Regulations in Japan and its filing process


Module-5


 important and Critical Notifications for all regulatory bodies Importance of stability Warning letters Recalls Guidelines Basics covering all the regulations Pharmacopoeias and their contents Impurities Indian Regulations - Drugs and Cosmetics Act  


 


FOR ANY QUERIES


FEEL FREE TO CONTACT


TS TECHNOLOGIES


303,PADMAJARAJA ENCLAVE ,


KPHB MAIN ROAD,HYDERABAD


+91-9951180008,8297989982.


E-mail: admin@tstechnologies.co.in  

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