Basics of Regulatory Affairs for Pharma Professional
Author | : Dr. Jayesh Dhalani |
Publisher | : Lulu.com |
Total Pages | : 127 |
Release | : |
Genre | : |
ISBN | : 0359963234 |
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Author | : Dr. Jayesh Dhalani |
Publisher | : Lulu.com |
Total Pages | : 127 |
Release | : |
Genre | : |
ISBN | : 0359963234 |
Author | : Javed Ali |
Publisher | : Academic Press |
Total Pages | : 287 |
Release | : 2021-11-14 |
Genre | : Medical |
ISBN | : 0128222239 |
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 | : Ilamathi.A.S |
Publisher | : Writers Corner Publication |
Total Pages | : 13 |
Release | : 2024-04-03 |
Genre | : Antiques & Collectibles |
ISBN | : |
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 | : C. F. Harrison |
Publisher | : Createspace Independent Publishing Platform |
Total Pages | : 66 |
Release | : 2016-08-19 |
Genre | : |
ISBN | : 9781537090740 |
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 | : Mark P. Mathieu |
Publisher | : Omec |
Total Pages | : 216 |
Release | : 1987 |
Genre | : Medical |
ISBN | : |
Author | : Kyyah Abdul |
Publisher | : Mango Media Inc. |
Total Pages | : 115 |
Release | : 2022-01-25 |
Genre | : Business & Economics |
ISBN | : 1642507571 |
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 | : John J. Tobin |
Publisher | : John Wiley & Sons |
Total Pages | : 304 |
Release | : 2011-08-24 |
Genre | : Science |
ISBN | : 3527644717 |
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 | : David Mantus |
Publisher | : CRC Press |
Total Pages | : 401 |
Release | : 2014-02-28 |
Genre | : Medical |
ISBN | : 1841849200 |
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 | : John J. Tobin |
Publisher | : John Wiley & Sons |
Total Pages | : 341 |
Release | : 2023-08-29 |
Genre | : Science |
ISBN | : 3527688986 |
Medical Product Regulatory Affairs Hands-on guide through the jungle of medical regulatory affairs for every professional involved in bringing new products to market Based on a module prepared by the authors for an MSc course offered by the University of Limerick, Ireland, Medical Product Regulatory Affairs is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. The Second Edition builds on the success of the first with an even wider scope and full coverage of new EU regulations on the safe use of medical devices. 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. Medical Product Regulatory Affairs includes information on: Aims and structure of regulation, covering purpose and principles of regulation, national and EU legislative processes, and pharmacopeia Regulatory strategy, covering product development and manufacturing, market vigilance, quality assurance systems, personnel, and documentation Drug discovery and development, covering prescription status, physical properties, therapeutic use, and drug discovery, development, and delivery Non-clinical studies, covering non-clinical study objectives and timing, pharmacological and pharmacodynamic studies, and bioavailability and bioequivalence Clinical trials, covering trial protocol, monitoring of trials, trial master files, and FDA communications The wide coverage of different product types and the main global markets makes Medical Product Regulatory Affairs ideal for training courses on regulatory affairs in academia and industry. It is also a valuable reference for pharmacologists, bioengineers, pharma engineers, and students in pharmacy to familiarize themselves with the topic.