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Pharma Regulatory Affairs Training in Hyderabad

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5 Days ago
5
Ad Information
  kphb colony Hyderabad
  N/A
Contact Information

Name : suresh

Tel. : 9951180008

Address : kphb colony

Zone : Andhra Pradesh

City : Hyderabad

Description

Pharma Regulatory Affairs Training in Hyderabad

Hi,

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

Tags : pharma,Regulatory Affairs

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