Press Reviews

MedR (2008) 26:462

…. Altogether, it is a very comprehensive and informative work. The professionally proven team of authors copes with the requirement of the work and, in the style of a practical reference work, imparts to the reader a survey (in respect of the contents) of a complex matter and, at the same time, gives him at hand a convenient tool. The fact that the book is written in English may discourage some of the readers. On the other hand the work is meant for readers who have to use the English language in their daily work anyway and therefore might appreciate the information in this work. The book can especially be recommended to lawyers who want to or have to make themselves familiar with the European drug law and appertaining questions relating to practice.
All things considered, it would be desirable for this beneficial work that it finds a widespread circulation.

Adem Koyuncu, Attorney at law and MD,
Mayer Brown LLP, Cologne (Germany)

Regulatory Affairs Focus Magazine

...The contents of the online version are arranged the same way but will be constantly updated and amended. Multiple search functions ease navigation. EU and European Medicines Agency (EMEA) communications and documents are commented upon and discussed. Links to official regulatory authorities’ documents and webpages provide instant access to relevant materials. The link compilation is completed by a newsletter, information and applications for upcoming events, and a job market. The online version is an extremely versatile tool for those deeply involved in regulatory affairs, from product development through the end of the product lifecycle...

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Regulatory Rapporteur

...The authors are well respected and recognised specialists in drug regulatory affairs in the European Union (and Switzerland), representing a good mixture of professionals from law, regulatory agencies and industry with regulatory practice.
Importantly, there are contributions from a number of other authors, all of them being recognised in the EU as specialists in their field.
In my view, such a book should be a standard text for all those working in drug regulatory affairs departments of pharmaceutical companies. By carefully following the advice in the book, many applications for Marketing Authorisation would be of a much higher quality, preventing lengthy comments from the reviewers of the agencies and thus, speeding up the time to market. Last but not least this
will save money and increase the company’s credibility and image at the agency...

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The recent book Guide to Drug Regulatory Affairs provides complete and thorough information about the regulatory approval process for human medicinal products in the European Union. The book was edited by Brigitte Friese, Barbara Jentges, and Usfeya Muazzam, and was published in 2007. It is packed with tables, figures, and flow charts that offer quick access to precise and timely data. The book's contributing authors have expertise in regulatory affairs and work in various European regulatory offices. The text is well written, easy to...
...In brief, the book supplies everything a manufacturer would need to plan a regulatory filing...

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This recently published comprehensive reference book provides an overview of the legal and regulatory framework for marketing authorisations with reference to the pertinent European provisions.
The work, whose legal part is based on two previously published books, “Die neuen Zulassungsverfahren für Arzneimittel” [New marketing authorisation procedures for medicinal products] and “Handbuch der EU-Zulassung” [Manual of marketing authorisations in the EU] by Friese (Collatz), provides commentaries on current requirements regarding marketing authorisations conforming with Directives 2001/83/EC, 2001/20/EC and other provisions...
...Overall, the Guide is a matchless and worthwhile work of reference that will be extremely useful to anyone involved in marketing authorisation procedures in Europe...

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Arzneimittel & Recht

Editio Cantor Verlag is advertising the “Guide to Drug Regulatory Affairs” self-consciously, saying that “this Guide is the first comprehensive overview of the legal and regulatory framework for marketing authorisation applications in Europe and Switzerland … [It] has been developed to penetrate the ‘regulatory jungle’ and makes related work much easier and more efficient.”
The IT and communication technology era has long come of age; nevertheless, it is quite a surprise that a reference like this “Guide” is available both as a print and online version. At close sight the question arises, though, why such products have not been offered previously – just in the pharmaceutical sector –, considering the fact that the law on medicinal products with its strong European character is amended on a regular basis. Any practitioner involved in the law on medicinal products who is aware of how busy the legislative is in this field will search for the current legal state of a standard – maybe even online – before resorting to the pertinent commentaries in print. In many cases, this is disappointing. Even loose-leaf collections that are expected to adopt current developments more quickly, sometimes hobble behind the legal situation.
After all, it is only consequential to provide an online version of a printed work to fulfil the demand for actuality by continuous updating...

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Edited by

Brigitte Friese
Barbara Jentges
Usfeya Muazzam

With special contri-
butions by
Sven Harmsen,
Susanne Keitel, Chris
Oldenhof, Klaus
Olejniczak, Henrike
Potthast, Joachim A.
Schwarz, and Barbara

Special contributions
related to Switzer-
land by
Dorothee Heer and
Thomas A. Keller

With a foreword by
Susanne Keitel