Author Archives: Zehava Brickner

PLI Discover PLUS: Implementation Guide

Implement GuideAre you a PLI Discover PLUS subscriber who needs assistance getting your subscription to Discover PLUS started?  Are you wondering what the steps are, who to contact, and how PLI can help you?  Look no further, PLI has created an Implementation Guide to help get up and running with your Discover PLUS subscription.

The PLI Discover PLUS Implementation Guide is full of information to help make your launch of Discover PLUS successful, including links to our online tutorial and coverage list, and information on IP authentication and obtaining MARC records.

New Book: Pharmaceutical Compliance and Enforcement Answer Book 2014

pharm compliance AB 2014Practising Law Institute (PLI) has  announced the release of their newest title, Pharmaceutical Compliance and  Enforcement Answer Book 2014. This valuable new guide provides a  comprehensive overview of the regulatory issues faced by the different  participants in the pharmaceutical industry.

Howard L. Dorfman, Vice President and General  Counsel at Ferring Pharmaceuticals Inc, served as editor to this valuable new  guide. His years of experience in FDA regulatory law make this new title a  must-have addition to every practicing attorney’s library.

In an easy-to-read Q&A format, Pharmaceutical Compliance and  Enforcement Answer Book 2014 is a roadmap filled with practical  suggestions to help the reader navigate his or her way to effective compliance  with FDA pharmaceutical regulations. The book clearly details:

  • 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

If you’d like to order Pharmaceutical Compliance and  Enforcement Answer Book 2014, please email the Library Relations Help Desk or call 877-900-5291.

 

Delaware Environmental Law Blog Reviews EPA Compliance and Enforcement Answer Book 2013

EPA Compliance AB 2013EPA Compliance and Enforcement Answer Book 2013, PLI’s new Answer Book, has been getting rave reviews!  Check out the latest review from Delaware Environmental Law Blog here and below.  If you have any questions or would like to order the book, please email the PLI Library Relations Department or call 877-900-5291.

Book Review: PLI’s New “EPA Compliance and Enforcement Answer Book 2013” is Worth the Price

By: Stephanie L. Hansen July 26, 2013

Adam Sowatzka & Richard E. Glaze, Jr. 2013.  EPA Compliance and Enforcement Answer Book 2013I.  Practising Law Institute: New York.  330 pages.  $255.00 from publisher; $232.75 from Amazon.com

Practicing Law Institute (“PLI”) has a new publication out that addresses EPA and, to the extent similar, State enforcement of environmental laws. To be frank with you, I don’t have any handbooks like this on my shelf and I wasn’t so sure one might be helpful. Before heading off to law school, I worked for the state environmental regulatory agency for eight years as a scientist and regulator, and I have a pretty good idea how enforcement actions are approached by the state. I also know that EPA enforcement is a different animal, but there are similarities.

So, I was surprised at how useful this book really is. It’s a practical book that I found I could begin using immediately. It isn’t a textbook, so if you want anything more than a very brief overview of the major environmental laws, look elsewhere. However, in order to concentrate the enforcement action information and keep the book as practical and useful, more background information on the major environmental laws would have been a distraction.

There are a couple of sleeper chapters on compliance monitoring and reporting and an overview of major federal environmental laws, and a couple of chapters with narrow subject matter that you may not come across in your practice (citizen suits, and imminent and substantial endangerment authority). But the bulk of the book is a behind-the-scenes look at how EPA approaches different kinds of enforcement actions (administrative, civil, and criminal), the interaction between state regulators and EPA, how penalties are calculated, and practical advice on regulatory inspections. Good stuff.

If, in your environmental practice, you have any interaction at all with EPA, then this is a book you need to have – not just in your office, but somewhere you can easily reach. It’s written in a question and answer format so that it’s an easy read, and importantly, it comes with a lot of tables and footnotes citing the myriad of EPA regulations, guidance documents, and important case law at the end of each chapter. I have already printed out three documents from the footnotes that have immediate, practical use in my practice. I can see how the table on EPA penalty amounts under the various federal programs, adjusted through time, will be a great resource as well as the table listing the EPA penalty policy documents under various programs. Also helpful is the table with links to EPA memoranda on supplemental environmental projects and a good discussion on bankruptcy and its effect on enforcement actions. I also like the way the book breaks down the subject matter of each chapter into discussions under CERCLA, RCRA, CAA, CWA, etc., and how it gets into the details and practicalities of enforcement actions (all kinds) under each of the major federal environmental laws.

EPA regulators are different than state regulators. Although they often share enforcement authority with the state regulators and the processes they use to come to conclusions may be similar to those employed by state regulators, they have different priorities and dealing with them requires a different mindset on your part. This book will help you understand the terrain and, importantly, will point you to additional reference material if you need to go deeper (which you undoubtedly will).

FREE Library One-Hour Audio Briefing: Legal and Ethical Issues in Social Media Library

PLI and LLAGNY teamed up to offer a free one-hour audio briefing to librarians, researchers, attorneys, and allied professionals: Legal and Ethical Issues in Social Media.Thank you to everyone who attended.

PLI and LLAGNY will continue to produce this series of Library Programs in the One-Hour Audio Briefing format.  The response has been positive, both from an attendance and feedback perspective.  Are you interested in speaking at a future briefing?  Or do you have a specific topic you’d like to see covered?  If so, please send your suggestions to libraryrelations@pli.edu.

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Please note this program has expired.  If you are interested in current PLI Library Programs, please visit www.pli.edu/libraryaudiobriefings.