Pharmaceutical Regulatory Affairs

Author : Javed Ali,Sanjula Baboota
Publisher : Academic Press
Page : 287 pages
File Size : 46,6 Mb
Release : 2021-11-14
Category : Medical
ISBN : 9780128222232

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Regulatory Affairs in the Pharmaceutical Industry by Javed Ali,Sanjula Baboota Pdf

Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance

Author : C. F. Harrison
Publisher : Createspace Independent Publishing Platform
Page : 66 pages
File Size : 55,6 Mb
Release : 2016-08-19
Category : Electronic
ISBN : 1537090747

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Pharmaceutical Regulatory Affairs by C. F. Harrison Pdf

Regulatory affairs. If you're finishing your academic career and are looking for a job in biotech or pharmaceuticals, you will have seen a thousand advertisements for regulatory affairs managers. But...what exactly is regulatory affairs? What would I be doing? What sort of skills do I need? What do I need to know before I start? This book answers all these questions and more, providing an introduction to the complex world of regulatory affairs. We cover typical tasks; required skills; the ins and outs of the submission process; vital knowledge you'll need to have; and much more. Lost in a sea of acronyms? We've got you covered. Not really sure how regulatory fits into pharmaceutical development? We explain the process. No idea why your new boss keeps going on about module 3.2.P.7? No problem. Whether you're looking for a job, preparing for an interview, or have just started in the field, this book will give you the foundational knowledge you need to succeed.

Author : David Mantus,Douglas J. Pisano
Publisher : CRC Press
Page : 401 pages
File Size : 41,9 Mb
Release : 2014-02-28
Category : Medical
ISBN : 9781841849201

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FDA Regulatory Affairs by David Mantus,Douglas J. Pisano Pdf

FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.

Author : Gloria Hall
Publisher : Unknown
Page : 128 pages
File Size : 42,7 Mb
Release : 2020-03-06
Category : Electronic
ISBN : 1947493418

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Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition by Gloria Hall Pdf

Author : John J. Tobin,Gary Walsh
Publisher : John Wiley & Sons
Page : 304 pages
File Size : 46,6 Mb
Release : 2011-08-24
Category : Science
ISBN : 9783527644711

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Medical Product Regulatory Affairs by John J. Tobin,Gary Walsh Pdf

Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

Author : Dr. Jayesh Dhalani
Publisher : Lulu.com
Page : 127 pages
File Size : 41,5 Mb
Release : 2024-06-30
Category : Electronic
ISBN : 9780359963232

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Basics of Regulatory Affairs for Pharma Professional by Dr. Jayesh Dhalani Pdf

Author : Mark P. Mathieu
Publisher : Omec
Page : 216 pages
File Size : 46,5 Mb
Release : 1987
Category : Medical
ISBN : UOM:39015012580224

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New Drug Development by Mark P. Mathieu Pdf

Author : Patrick M. Malone,Karen L. Kier,John Stanovich
Publisher : McGraw Hill Professional
Page : 907 pages
File Size : 48,5 Mb
Release : 2010-05-12
Category : Medical
ISBN : 9780071492034

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Drug Information by Patrick M. Malone,Karen L. Kier,John Stanovich Pdf

Extensive coverage of the Internet as a source of and distribution means for drug information, and detailed sections on evaluating medical literature from clinical trials Audience includes Pharmacists, Pharmacy students and Pharmacy schools Updated to include using PDAs for medication information Covers the ethical and legal aspects of drug information management Nothing else like it on the market

Author : Ilamathi.A.S,Nikkila devi.R
Publisher : Writers Corner Publication
Page : 13 pages
File Size : 46,7 Mb
Release : 2024-04-03
Category : Antiques & Collectibles
ISBN : 9798321819531

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REVIEW ON PHARMACEUTICAL REGULATORY AFFAIRS by Ilamathi.A.S,Nikkila devi.R Pdf

ABSTRACT: Regulatory affairs in the pharmaceutical industry play an important role in ensuring the safety, efficacy, and quality of medicinal products worldwide. The pharmaceutical drug regulatory affairs profession was developed from the desire all over the world to protect public health by providing good quality medicine including safety and efficacy in the area of not only pharmacy but also in the area of veterinary medicine, medical devices, insecticides, pesticides, agrochemical, cosmetic and complementary medicine. Regulatory affairs acts as an interface between the pharmaceutical company and the regulatory agencies. The key role of regulatory affairs professions includes maintaining Compliance, Product approval, Risk management, Market access, Quality assurance. It works under proper organizational structure and various regulatory bodies around the world. Regulatory affairs professional also involves in clinical trail and R&D to develop innovative products that take advantage of new technological and regulatory developments to accelerate time to market. They can face regulatory non-compliance issues, but drug developers can also look to tech-enabled solutions to improve regulatory compliance. Regulatory affairs should explore whether the different innovation in pharma can decrease the risk of compliance issues.

Author : Jack Wong,Raymond K. Y. Tong
Publisher : CRC Press
Page : 806 pages
File Size : 55,6 Mb
Release : 2022-01-27
Category : Medical
ISBN : 9781000440515

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Medical Regulatory Affairs by Jack Wong,Raymond K. Y. Tong Pdf

This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.

Author : Vandana B. Patravale,John I. Disouza,Maharukh Rustomjee
Publisher : CRC Press
Page : 433 pages
File Size : 42,6 Mb
Release : 2016-05-25
Category : Medical
ISBN : 9781498730785

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Pharmaceutical Product Development by Vandana B. Patravale,John I. Disouza,Maharukh Rustomjee Pdf

Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof. Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms. The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.

Author : Dr Ns Vyawahare,MR Sachin C Itkar
Publisher : Nirali Prakashan
Page : 128 pages
File Size : 47,9 Mb
Release : 2024-06-30
Category : Electronic
ISBN : 9380064683

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Drug Regulatory Affairs by Dr Ns Vyawahare,MR Sachin C Itkar Pdf

Regulatory Affair and its Importance - Drug Discover and Development - Regulatory Strategy - Investigational New Drug Application IND - New Drug Application NDA - Abbreviated New Drug Application ANDA - Drug Master File DMF - Orphan Drug - Biological Licensing Application BLA - Registrationa of Drug Products in Overseas Markets Pharmaceutical export - Regulatory Authorities and Agencies - Overview of Drug and Cosmetic Act - Regulatory Guidelines - Useful Information

Author : Helene I. Dumitriu
Publisher : CRC Press
Page : 440 pages
File Size : 44,5 Mb
Release : 2019-12
Category : Electronic
ISBN : 0367448084

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Good Drug Regulatory Practices by Helene I. Dumitriu Pdf

Good Drug Regulatory Practices offers a series of policies and procedures to assure quality and timely regulatory submissions to national regulatory agencies. This book begins with introductory chapters describing the need for policy documentation, and the philosophy underlying the policies, and presents policies and standards that can be used as presented or adapted to individual situations in your company.

Author : Dr. S. Valarmathi, Dr. Anasuya Patil, Dr. Abhishek Suman, Mr Vinay Kumar Yanmandru, Dr. NARLA SUNITHA, Prof. (Dr.) Varsha Deva
Publisher : Shashwat Publication
Page : 452 pages
File Size : 53,6 Mb
Release : 2023-08-04
Category : Medical
ISBN : 9788119281244

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TEXTBOOK ON PHARMACEUTICAL REGULATORY AFFAIRS by Dr. S. Valarmathi, Dr. Anasuya Patil, Dr. Abhishek Suman, Mr Vinay Kumar Yanmandru, Dr. NARLA SUNITHA, Prof. (Dr.) Varsha Deva Pdf

This book structured in TWO different parts. These parts are as follows: Part I emphasizes on GCP (Good Clinical Practices), GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), USFDA-NDA/ANDA (U S Food and Drug Administrations- New Drug Approval/Abbreviated New Drug Approval) and TQM (Total Quality Management). GCP (Good Clinical Practices) is an international quality standard that is provided by International Conference on Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. Good Clinical Practice guidelines include protection of human rights as a subject in clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. Good Clinical Practice Guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry monitors are often called Clinical Research Associates. GLP (Good Laboratory Practices) deals with the organization, process and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. GLP practices are intended to promote the quality and validity of test data. Published GLP regulations and guidelines have a significant impact on the daily operation of an analytical laboratory. GMP (Good Manufacturing Practices) Manufacturing relies on the ability to reproduce exactly a single product hundreds, if not thousands, of times. To make this possible, guidelines have been drawn up in most countries that are similar to the FDA ones described here that define GMPs. Diagnostic companies, including those manufacturing and distributing biosensors, cannot sell their products for either public or professional use unless they have been approved on the basis of these guidelines. USFDA-NDA/ANDA (U S Food and Drug Ad

Author : Douglas J. Pisano,David S. Mantus
Publisher : CRC Press
Page : 466 pages
File Size : 40,7 Mb
Release : 2008-08-11
Category : Medical
ISBN : 9781040061978

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FDA Regulatory Affairs by Douglas J. Pisano,David S. Mantus Pdf

Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in