pharma regulatory affairs online training

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  • Published date: June 4, 2019
  • Modified date: June 4, 2019
    • Kphb, Hyderabad, Andhra Pradesh, India [ Ad Id - 70908 | Ad Views - 7 ]

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 expert

We offer only 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: [email protected]

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