pharmaceutical compliance and enforcement answer book 2016

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Pharmaceutical Compliance And Enforcement Answer

Author : Howard L. Dorfman
ISBN : 1402426135
Genre : Law
File Size : 88. 23 MB
Format : PDF, Kindle
Download : 163
Read : 831

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PLI's Pharmaceutical Compliance and Enforcement Answer Book 2016 provides a comprehensive overview of the regulatory issues faced by the different participants in the pharmaceutical industry. In an easy Q&A format, Pharmaceutical Compliance and Enforcement Answer Book 2016 describes: The FDA's authority and potential actions to regulate prescription drugs and biologics both before and after approval by the agency A facility's rights and compliance obligations during an inspection by the agency How to best evaluate a company's potential of being in violation and what to do to mitigate those risks What advertising and promotion of prescription drugs is permitted How product liability issues overlap with FDA enforcement initiatives When criminal prosecution is used as part of the regulatory enforcement effort Filled with practical suggestions, Pharmaceutical Compliance and Enforcement Answer Book 2016 provides the attorney and his or her clients with a roadmap to effective compliance with FDA pharmaceutical regulations."

Pharmaceutical Compliance And Enforcement Answer Book

Author : Howard L. Dorfman
ISBN : 1402431392
Genre : Law
File Size : 80. 60 MB
Format : PDF, ePub
Download : 968
Read : 503

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Pharmaceutical Compliance and Enforcement Answer Book provides a comprehensive overview of the regulatory issues faced by the different participants in the pharmaceutical industry.In an easy Q&A format, this resource discusses: The FDA's authority and potential actions to regulate prescription drugs and biologics both before and after approval by the agencyA facility's rights and compliance obligations during an inspection by the agencyHow to best evaluate a company's potential of being in violation and what to do to mitigate those risksWhat advertising and promotion of prescription drugs is permittedHow product liability issues overlap with FDA enforcement initiativesWhen criminal prosecution is used as part of the regulatory enforcement effortFilled with practical suggestions, Pharmaceutical Compliance and Enforcement Answer Book provides attorneys and compliance officers with a roadmap to effective compliance with FDA pharmaceutical regulations.

Private Law In The External Relations Of The Eu

Author : Marise Cremona
ISBN : 9780191062018
Genre : Law
File Size : 51. 72 MB
Format : PDF
Download : 165
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Private Law in the External Relations of the EU is an innovative study of the interactions between EU external relations law and private law, two unrelated fields of law, inverted if private law is understood as regulatory private law - the space where regulatory law intersects with private economic activity. Here the link between the Internal Market and the global market - and thereby international law - is much more prominent. In this book, key questions about the relationship between EU external relations law and private law are answered, including: in what ways might European private law act as a tool to achieve EU external policy objectives, particularly in regulatory fields? How might the quickly developing EU external competence over the procedural dimensions of private law, including private international law, impact on substantive law, both externally and internally? And how is the legal position of private parties affected by EU external relations? In asking these questions, this edited collection opens up a field of enquiry into the so far underexplored relationship between these two fields of law. In doing so, it addresses three different aspects of the relationship: (i) the evolution of the EU competence, (ii) the ways in which EU private law extends its reach beyond the boundaries of the internal market, and (iii) the ways in which the EU contributes to the formation of private regulation at the international level.

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