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Check with seller Regulatory Affairs Training in Hyderabad Hyderabad

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Other Classes Published date: November 7, 2017
  • Country: India
  • Region: Andhra Pradesh
  • City: Hyderabad
  • City area: Kphb Colony
  • Address: Kphb

Welcome To Ts technologies


 


Greetings from Ts technologies


 


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 & RA


 


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


 


We offer only regular , Weekend 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 judgements


 


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


 


Phone: 9951180008

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