Rajkumar Gupea, M.Pharm. Regulatory Mentor ot Perfees Pharmaceutical consudicous Pur Limited: lou. 1 rv vile professional regutatory servises on cGMP AulitsTraining, ANDA, NDA IND, CEP, DME, PY, PSUR. Contact perfectdassiersGigracil.cont visit INTELLIGENT RA QUESTIONS (100) PARTI Rajkumar M. Gupta, M.Pharm. , Expert in US and EU Regulatory Compliance Regulatory Mentor at Perfect Pharmaceutical Consultant Pvt Limited, Pune, India Laccept assignments for US DMF, CTD, ¢CTD, variations filing and GMP audits, regulatory training as pet FDA standards, Contact at: perfectdossierst@ gmail com or at (HF91 937 1020804 fecidassierscam INTRODUCTION ‘Today marketing authorization has become integral and intelligent part of Pharmaceutical Business, The detailed knowledge and application of drug regulations have become compulsory for marketing OTC, Generic drugs, new drugs, and medical devices and Biological ‘This presentation “Intelligent RA Questions” is designed to wain you for RAC and similar competitive examinations. The questions are desi gned to test your knowledge and aptitude both, ‘The answers to the questions are provided in another file labeled as “Answers.” ‘You are requested to attempt the questions first and then compare your answers provided in Answer File ‘This tutorial: contains 100 questions and the time allotted is 150 minutes i.e. more than 1 for each question, If you can successfully master such 100 tutorials perhaps you can qualify any competitive examination including RAC. ‘This question set contains questions mainly on US Regulatory Affairs If you are interested in enrolling for all 100 tutorials please let me know at ‘d.questions@ gmail.com or perfectdossiers@gmailcom 1. | WhatareSUPAC ‘These are the guidelines for Seale-up and Post Guidelines? approval changes after the product has been granted marketing Authorization ‘These are applicable 10 both new and generic products 2. | Which are the important | US FDA and Health Canada international regulatory | EMA and EDQM bodies? MHRA TGA MHW (Japan) regulatory associations in the world 4 | Whatisthenormallife | Generally, the product patent is for 20 years span of product and ‘The process patent is forever until itis withdrawn process patent’? S._| Why application for Unlike new drugs the generic drugs are not © Copyright by Mr. Rajkumar Gupta, August 2014 India. All rights reserved.