Pharmaceutical Regulatory Affairs

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Regulatory Affairs in the Pharmaceutical Industry

Author : Javed Ali
Publisher : Academic Press
ISBN 13 : 0128222239
Total Pages : 287 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Regulatory Affairs in the Pharmaceutical Industry by : Javed Ali

Download or read book Regulatory Affairs in the Pharmaceutical Industry written by Javed Ali and published by Academic Press. This book was released on 2021-11-14 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

New Drug Development

Author : Mark P. Mathieu
Publisher : Omec
ISBN 13 :
Total Pages : 216 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis New Drug Development by : Mark P. Mathieu

Download or read book New Drug Development written by Mark P. Mathieu and published by Omec. This book was released on 1987 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Medical Product Regulatory Affairs

Author : John J. Tobin
Publisher : John Wiley & Sons
ISBN 13 : 3527644717
Total Pages : 304 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Medical Product Regulatory Affairs by : John J. Tobin

Download or read book Medical Product Regulatory Affairs written by John J. Tobin and published by John Wiley & Sons. This book was released on 2011-08-24 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition

Author : Gloria Hall
Publisher :
ISBN 13 : 9781947493414
Total Pages : pages
Book Rating : 4.4/5 (934 download)

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Book Synopsis Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition by : Gloria Hall

Download or read book Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition written by Gloria Hall and published by . This book was released on 2020-03-06 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Pharmaceutical Regulatory Affairs

Author : C. F. Harrison
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781537090740
Total Pages : 66 pages
Book Rating : 4.0/5 (97 download)

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Book Synopsis Pharmaceutical Regulatory Affairs by : C. F. Harrison

Download or read book Pharmaceutical Regulatory Affairs written by C. F. Harrison and published by Createspace Independent Publishing Platform. This book was released on 2016-08-19 with total page 66 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

FDA Regulatory Affairs

Author : David Mantus
Publisher : CRC Press
ISBN 13 : 1841849200
Total Pages : 401 pages
Book Rating : 4.8/5 (418 download)

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Book Synopsis FDA Regulatory Affairs by : David Mantus

Download or read book FDA Regulatory Affairs written by David Mantus and published by CRC Press. This book was released on 2014-02-28 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Pharmaceutical Product Development

Author : Vandana B. Patravale
Publisher : CRC Press
ISBN 13 : 1498730787
Total Pages : 433 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Pharmaceutical Product Development by : Vandana B. Patravale

Download or read book Pharmaceutical Product Development written by Vandana B. Patravale and published by CRC Press. This book was released on 2016-05-25 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Medical Regulatory Affairs

Author : Jack Wong
Publisher : CRC Press
ISBN 13 : 1000440516
Total Pages : 806 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Medical Regulatory Affairs by : Jack Wong

Download or read book Medical Regulatory Affairs written by Jack Wong and published by CRC Press. This book was released on 2022-01-27 with total page 806 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Drug Regulatory Affairs

Author : Dr Ns Vyawahare
Publisher : Nirali Prakashan
ISBN 13 : 9789380064680
Total Pages : pages
Book Rating : 4.0/5 (646 download)

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Book Synopsis Drug Regulatory Affairs by : Dr Ns Vyawahare

Download or read book Drug Regulatory Affairs written by Dr Ns Vyawahare and published by Nirali Prakashan. This book was released on with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Basics of Regulatory Affairs for Pharma Professional

Author : Dr. Jayesh Dhalani
Publisher : Lulu.com
ISBN 13 : 0359963234
Total Pages : 127 pages
Book Rating : 4.3/5 (599 download)

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Book Synopsis Basics of Regulatory Affairs for Pharma Professional by : Dr. Jayesh Dhalani

Download or read book Basics of Regulatory Affairs for Pharma Professional written by Dr. Jayesh Dhalani and published by Lulu.com. This book was released on with total page 127 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Drug Information

Author : Patrick M. Malone
Publisher : McGraw Hill Professional
ISBN 13 : 0071492038
Total Pages : 907 pages
Book Rating : 4.0/5 (714 download)

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Book Synopsis Drug Information by : Patrick M. Malone

Download or read book Drug Information written by Patrick M. Malone and published by McGraw Hill Professional. This book was released on 2010-05-12 with total page 907 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

FDA Regulatory Affairs

Author : Douglas J. Pisano
Publisher : CRC Press
ISBN 13 : 9781135436025
Total Pages : 0 pages
Book Rating : 4.4/5 (36 download)

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Book Synopsis FDA Regulatory Affairs by : Douglas J. Pisano

Download or read book FDA Regulatory Affairs written by Douglas J. Pisano and published by CRC Press. This book was released on 2003-12-23 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the enactment of the first drug law in 1848, the legislation surrounding drug development has evolved into a maze of regulations that can be hard to navigate. Not only are existing regulations constantly reviewed and updated, the increasingly rapid rate of development in the pharmaceuticals field creates new issues that need to be addressed by new legislation. Written in plain language without confusing jargon or legalese, FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics provides a roadmap to the myriad and sometimes confusing regulations that govern this constantly changing field. The book examines the pertinent aspects of the Federal Food, Drug, and Cosmetic Act as they apply to human drug and device development, research, manufacturing, and marketing. It focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and the corresponding documentation requirements. Although there are a number of references on these topics, this book is unique in that it is written in a general, easy to read prose style. It presents information drawn from a wide range of resources in a single, easy to use format. FDA approval can be a lengthy and expensive process. In order for a pharmaceutical manufacturer to place a product on the market for human use, a multiphase procedure must be followed. Providing a reference for students, professionals, and especially those who are charged with the day-to-day tasks of assuring regulatory compliance under FDA guidelines, this book demystifies the inner workings of the FDA and allows you to understand how it operates with respect to product approval.

Pharmaceutical Regulatory Environment

Author : Reem K. Al-Essa
Publisher : Springer
ISBN 13 : 3319175904
Total Pages : 236 pages
Book Rating : 4.3/5 (191 download)

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Book Synopsis Pharmaceutical Regulatory Environment by : Reem K. Al-Essa

Download or read book Pharmaceutical Regulatory Environment written by Reem K. Al-Essa and published by Springer. This book was released on 2015-05-06 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which, if fully implemented, could have a significant impact on patients’ access to new medicines. The Persian Gulf represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is considered critical to the future regulatory environment in this region. Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region.

The Prepared Graduate

Author : Kyyah Abdul
Publisher : Mango Media Inc.
ISBN 13 : 1642507571
Total Pages : 115 pages
Book Rating : 4.6/5 (425 download)

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Book Synopsis The Prepared Graduate by : Kyyah Abdul

Download or read book The Prepared Graduate written by Kyyah Abdul and published by Mango Media Inc.. This book was released on 2022-01-25 with total page 115 pages. Available in PDF, EPUB and Kindle. Book excerpt: Professional Advice About Career Preparation for Soon-To-Be College Grads “This book is so real and honest! I wish I had this when I first started out in my career....Every parent should read this book and then gift it to their child! ” —Nancy Barrows, MS CC-SLP, LAUSD educator & speech language pathologist This book of professional advice about career preparation may be the best college graduation gift you’ll receive. Too many people end up working jobs they didn’t study for. It’s time you proactively prepare for post-graduate life. The Prepared Graduate speaks to Generation Z and Millennials, addressing many of the concerns students (and parents) have about pre- and post-graduation. Kyyah Abdul offers extensive job search tips and work advice, such as guidance on writing the perfect résumé, excelling in job interviews, networking in-person and online, negotiating job salaries, paying off student loans, and more. Rely on trusted guidance. Armed with first-hand experience with the lack of preparation universities provide their students, Kyyah set out to forge her own path for finding relevant work post-graduation. Her strategies helped her land jobs in several STEM positions both during and after college. Over time, Kyyah created a comprehensive roadmap chockfull of work advice for college seniors through summer up until the end of their first year as a graduate. The Prepared Graduate is the perfect college graduation gift that provides: • Guidance on finding the right path for career success • An easy-to-follow roadmap with advice about career preparation • Endless job search tips If you enjoyed What Color is Your Parachute? (2021); Brag Better: Master the Art of Fearless Self-Promotion; or You Turn: Get Unstuck, Discover Your Direction, and Design Your Dream Career, you’ll love The Prepared Graduate.

Good Drug Regulatory Practices

Author : Helene I. Dumitriu
Publisher : CRC Press
ISBN 13 : 9780367448080
Total Pages : 440 pages
Book Rating : 4.4/5 (48 download)

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Book Synopsis Good Drug Regulatory Practices by : Helene I. Dumitriu

Download or read book Good Drug Regulatory Practices written by Helene I. Dumitriu and published by CRC Press. This book was released on 2019-12 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309222176
Total Pages : 118 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development by : Institute of Medicine

Download or read book Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development written by Institute of Medicine and published by National Academies Press. This book was released on 2012-04-04 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.

REVIEW ON PHARMACEUTICAL REGULATORY AFFAIRS

Author : Ilamathi.A.S
Publisher : Writers Corner Publication
ISBN 13 :
Total Pages : 13 pages
Book Rating : 4.3/5 (218 download)

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Book Synopsis REVIEW ON PHARMACEUTICAL REGULATORY AFFAIRS by : Ilamathi.A.S

Download or read book REVIEW ON PHARMACEUTICAL REGULATORY AFFAIRS written by Ilamathi.A.S and published by Writers Corner Publication. This book was released on 2024-04-03 with total page 13 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.