Pharmaceutical and Medical Device Compliance Manual

Pharmaceutical and Medical Device Compliance Manual PDF

Author: Ela Bochenek

Publisher:

Published: 2019

Total Pages: 319

ISBN-13: 9781522178026

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A robust compliance program is essential to protecting a company from running afoul of the myriad laws and regulations that have been enacted to combat fraud and waste. The second edition of the Pharmaceutical and Medical Device Compliance Manual includes guidance to help companies develop a compliance program tailored to today's complex enforcement and business environment. Study of this Manual will enable compliance professionals and lawyers to understand the government's expectations of an effective compliance program and ethical business practices, as well as: how the government discovers potential enforcement actions, its approach to pursuing such actions, what behaviors can constitute mitigating factors for a company in the event of a legal violation. Coverage includes new chapters covering:Pharmaceutical industry interactions with patient organizations Compliance 2.0: compliance analytics in the era of big dataThe art and science of health care compliance in the pharmaceutical and medical device industries The Manual will be a great tool for health and life sciences attorneys, compliance officers, and others in the pharmaceutical and medical devices industry

Medical Regulatory Affairs

Medical Regulatory Affairs PDF

Author: Jack Wong

Publisher: CRC Press

Published: 2022-01-27

Total Pages: 620

ISBN-13: 1000440532

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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.

Medical Device Regulations

Medical Device Regulations PDF

Author: Aakash Deep

Publisher: Academic Press

Published: 2022-01-13

Total Pages: 187

ISBN-13: 0323911277

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Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers the registration procedures of medical devices for pharmaceutical regulatory organizations. Sections provide guidance on dealing with the ethical considerations of medical device development, compliance with patient confidentiality using information from medical devices, the interoperability between, and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety. The author brings forth relevant issues, challenges and demonstrates how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom-line by demystifying the regulatory impact on operational requirements. Provides clear information on regulatory pathways for the design and commercialization of Medical Devices in different countries Explains the difference between standards and mandatory regulations for each region, along with discussions of regulations from USFDA (USA), CDSCO (India), EMEA (European Union), SFDA (China) and PMDA (Japan) Compiles regulations for medical devices and pharmaceuticals worldwide, helping readers create globally compliant products

Handbook of Medical Device Regulatory Affairs in Asia

Handbook of Medical Device Regulatory Affairs in Asia PDF

Author: Jack Wong

Publisher: CRC Press

Published: 2013-03-27

Total Pages: 618

ISBN-13: 9814411213

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Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.

Managing Relationships with Industry

Managing Relationships with Industry PDF

Author: Steven C. Schachter

Publisher: Academic Press

Published: 2010-07-28

Total Pages: 310

ISBN-13: 0080559557

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Now more than ever, doctors are being targeted by government prosecutors and whistleblowers challenging the legality of their relationships with drug and device companies. With reputations at stake and the risk of civil and criminal liability, it is incumbent upon doctors to protect themselves. Managing Relationships with Industry: A Physician’s Compliance Manual is an indispensable resource for doctors, professional societies, academic medical centers, community hospitals, and group practices struggling to understand the ever changing law and ethical standards on interactions with pharmaceutical and device companies. It is the first comprehensive summary of the law and ethics on physician relationships with industry written for the physician. Authored by a former state Attorney General, Harvard Medical School Professor, health care lawyer and professor of ethics, Managing Relationships approaches the topic from a balanced and reasoned perspective adding to the on-going national dialogue and debate on the proper limits to medicine’s relationship with industry. The first complete and up-to-date summary and analysis of the law and ethics on physician-industry relationships Focuses on major enforcement actions and whistleblower lawsuits and the lessons learned for physicians Provides options and guidance for maintaining compliant relationships and avoiding traps for the unwary Covers both drug and device company relationships Summarizes the types of industry relationships that are necessary and productive and those that are harmful and abusive Details the law and ethics for each type of relationship including gifts, off-label uses and marketing, CME, speaker’s bureaus, free samples, grants, consulting arrangements, etc. Includes sample contracts for permissible consulting and CME speaker engagements

FDA Regulatory Affairs

FDA Regulatory Affairs PDF

Author: Douglas J. Pisano

Publisher: CRC Press

Published: 2008-08-11

Total Pages: 466

ISBN-13: 1040061974

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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

Pharmacy Department Compliance Manual

Pharmacy Department Compliance Manual PDF

Author: Aspen Health Law and Compliance Center

Publisher:

Published: 1999

Total Pages: 372

ISBN-13:

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Never before has there been more help to comply with complex pharmacy department regulations. In Pharmacy Department Compliance Manual, you get everything you need to stay in compliance. 1) Legal compliance questions and answers: Find the legal answers you need in seconds. 2) Joint Commission survey questions and answers: Get inside guidance from colleagues who have been there. 3) Hospital accreditation standard analysis: Learn about Joint Commission standards as they apply To The pharmacy department. 4) Reference materials for pharmacy department compliance: All the tools you need to comply with pharmacy-related regulations, laws, and accreditation standards. Includes a diskette containing many of the forms, policies, procedures, and other documentation within the Reference Materials section.

Medical Device Regulation

Medical Device Regulation PDF

Author: Elijah Wreh

Publisher: Elsevier

Published: 2023-02-22

Total Pages: 680

ISBN-13: 0323953530

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Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices. Offers a unique focus on the regulatory affairs industry, specifically targeted at regulatory affairs professionals and those seeking certification Puts regulations in the context of contemporary design Includes case studies and applications of regulations

Data Integrity in Pharmaceutical and Medical Devices Regulation Operations

Data Integrity in Pharmaceutical and Medical Devices Regulation Operations PDF

Author: Orlando Lopez

Publisher: CRC Press

Published: 2016-11-03

Total Pages: 268

ISBN-13: 1315349973

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Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years’ experience in regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.

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