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Huma Khan. Show More. No Downloads. Views Total views. Actions Shares. No notes for slide. What is Regulatory Affairs? Ans-Regulatory Affairs in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world. It is mainly involved in the registration of the drug products in respective countries prior to their marketing.
What are the goals of Regulatory Affairs Professionals? Ans- It is an application which is filed with FDA to get approval for legally testing an experimental drug on human subjects in the USA 3.
What are the Roles of Regulatory Affairs professionals? What is a New Drug Application? Ans- A generic drug product is the one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.
What is a Marketing Authorization Application? What is a DMF? Ans- A Drug Master File DMF is a submission to the Food and Drug Administration FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
What are the examples of changes to approved drug products for which b 2 application should be submitted? What are the chemical classification codes for NDA? Ans- 9. Generally, filed for newly invented pharmaceuticals. Generally, filed for new dosage form, new route of administration, new indication etc for all already approved pharmaceutical.
What are the differences between NDA and b 2 application? Ans- Note: b 2 application is a type of NDA. What is an ASMF? Ans-Active substance master file is a submission which is made to EMA, MHRA or any other Drug Regulatory Authority in Europe to provide confidential intellectual property or 'know-how' of the manufacturer of the active substance.
What are the types of active substances for which ASMFs are submitted? Ans-International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH : is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration.
What is CTD? What are the modules in CTD? Administrative information and prescribing information Module 2. Common Technical Document summaries Overview and summary of modules 3 to 5 Module 3. Quality Module 4. Nonclinical Study Reports toxicology studies Module 5.
What is Hatch-Waxman act? It is considered as the landmark legislation which established the modern system of generic drugs in USA. Hatch-Waxman amendment of the federal food, drug and cosmetics act established the process by which, would be marketers of generic drugs can file Abbreviated New Drug Application ANDA to seek FDA approval of generic drugs.
This certification must state one of the following: I that the required patent information relating to such patent has not been filed Para I certification ; II that such patent has expired Para II certification ; III that the patent will expire on a particular date Para III certification ; or IV that such patent is invalid or will not be infringed by the drug, for which approval is being sought Para IV certification.
What is meant by day exclusivity? The recent example is- day exclusivity was granted to Ranbaxy and Watson Laboratories for marketing generic version of Lipitor Atorvastatin calcium. What are the procedures for Approval of Drug in EU? What is the Full form of abbreviation, CEP? Ans- It is the certificate which is issued by Certification of Substances Division of European Directorate for the Quality of Medicines EDQM , when the manufacturer of a substance provides proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia.
As on 14th March, Ans- Full forms of some of the Abbreviations related to Regulatory Affairs- S. As on 14 th March, Ans- It is the certificate which is issued by Certification of Substances Division of European Directorate for the Quality of Medicines EDQM , when the manufacturer of a substance provides proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia.
Ans- Certificate of Suitability to the monographs of the European Pharmacopoeia or Certificate of suitability of monographs of the European Pharmacopoeia or Certification of suitability of European Pharmacopoeia monographs It is also informally referred to as Certificate of Suitability COS Ans : Active substance master file is a submission which is made to EMA, MHRA or any other Drug Regulatory Authority in Europe to provide confidential intellectual property or 'know-how' of the manufacturer of the active substance.
Ans It is the certificate which is issued by Certification of Substances Division of European Directorate for the Quality of Medicines EDQM , when the manufacturer of a substance provides proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia. You just clipped your first slide! Clipping is a handy way to collect important slides you want to go back to later. Now customize the name of a clipboard to store your clips. Visibility Others can see my Clipboard.
To ensure that you are prepared and increase your chances of success, we recommend studying the job description. From this, you may be able to predict some of the types of questions that are likely to be asked at the interview. It is useful to match the job description against your CV. Then, you can think about when and where you have been able to demonstrate the skills, characteristics and experience the interviewer is looking for, and identify the most important aspects of the role. If you need help with your CV, find our advice here.
Part I. regulatory affairs associate interview questions and answers: regulatory affairs associate interview question: please tell me about yourself.
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Finding another job can be so cumbersome that it can turn into a job itself. Prepare well for the job interviews to get your dream job. Here's our recommendation on the important things to You need to prepare for the job interview to achieve your career goals in an easy way. Regulatory Affairs is a government job handling the central affairs in fields such as industries, pharma, banking, energy, telecom etc. Their responsibilities are - working with federal, state, and local regulatory agencies, ensuring that their companies comply with all of the regulations and many more.
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В отношении шифровалки в АНБ сложилась своеобразная философия. Нет смысла вбухивать миллиарды долларов в дешифровальный компьютер и одновременно экономить на тех, кто работает на этой превосходной технике. Сьюзан скинула туфли на низких каблуках от Сальваторе Феррагамо и блаженно погрузила обтянутые чулками ноги в густой шерстяной ковер. Высокооплачиваемые государственные служащие старались избегать демонстрации личного благосостояния. Для Сьюзан это не составляло проблемы: она была безмерно счастлива в своей скромной двухкомнатной квартире, водила вольво и довольствовалась весьма консервативным гардеробом.
- Весь мой план рухнет. Должен быть какой-то другой выход. - Решайте! - крикнул Хейл и потащил Сьюзан к лестнице. Стратмор его не слушал. Если спасение Сьюзан равнозначно крушению его планов, то так тому и быть: потерять ее значило потерять все, а такую цену он отказывался платить.
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+ Regulatory Affairs Interview Questions and Answers, Question1: What is Regulatory Affairs? Question2: What are the goals of Regulatory Affairs.