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Author: Javed Ali
Publisher: Academic Press
ISBN: 0128222239
Category : Medical
Languages : en
Pages : 287
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Book Description
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: Javed Ali
Publisher: Academic Press
ISBN: 0128222239
Category : Medical
Languages : en
Pages : 287
Get Book Here
Book Description
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
ISBN: 9781537090740
Category :
Languages : en
Pages : 66
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Book Description
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: Kyyah Abdul
Publisher: Mango Media Inc.
ISBN: 1642507571
Category : Business & Economics
Languages : en
Pages : 115
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Book Description
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.
Author: Dr. Jayesh Dhalani
Publisher: Lulu.com
ISBN: 0359963234
Category : Science
Languages : en
Pages : 127
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Book Description
Pharma regulatory affairs, very difficult to understand for the person who wants to enter in the field of pharma and chemical industries. Here i have presented extract of different guideline in digestive language with all the difficult terminologies. Students of bachelors, masters, research scholars can easily select their career path in field of pharma regulatory affairs. The book contains basic idea of Quality, GMP, GLP, Validation, Impurity, Drug master file, calibration, Standard operating procedure, ICH guideline and Validation methodology. The book will surely fulfill the basic requirement of pharma regulatory affairs.
Author: David Mantus
Publisher: CRC Press
ISBN: 1841849200
Category : Medical
Languages : en
Pages : 401
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Book Description
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: Patrick M. Malone
Publisher: McGraw Hill Professional
ISBN: 0071492038
Category : Medical
Languages : en
Pages : 907
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Book Description
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: Mark P. Mathieu
Publisher: Omec
ISBN:
Category : Medical
Languages : en
Pages : 216
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Book Description
Author: Jack Wong
Publisher: CRC Press
ISBN: 1000440516
Category : Medical
Languages : en
Pages : 806
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Book Description
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: Douglas J. Pisano
Publisher: CRC Press
ISBN: 1040061974
Category : Medical
Languages : en
Pages : 466
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Book Description
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
Author: Reem K. Al-Essa
Publisher: Springer
ISBN: 3319175904
Category : Medical
Languages : en
Pages : 246
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Book Description
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.
