This is the last print issue of Regulatory Focus. Starting next month, Focus will be available only electronically on regulatoryfocus.org.
Since its inception in January of 1996, Focus has been the flagship publication for regulatory professionals around the world. In more than 2,000 feature articles published over the last 15 years, it has provided a platform to discuss a vast array of topics of interest to regulatory professionals.
Each month, Focus picks a central theme, with four to six feature articles discussing different aspects of that theme. In addition, Focus includes articles in departments to address other topics of interest to regulatory professionals.
One common complaint about Focus has been that feature articles tend to be dated due to the editorial process and the production cycle, and that regulatory professionals had to look elsewhere for current news and events. To keep Focus at the top of a regulatory professional's reading list, it was decided to transition to a digital format.
Starting in January, Focus will be available in a new web-friendly digital version that members can access on their computers, smart phones, tablets and other electronic gizmos. All articles will be searchable, making it easier to find Focus articles online.
The digital version will also provide easy and inexpensive access internationally. In recent surveys, RAPS members have expressed a desire for electronic availability of Focus. But this change comes at a cost; for logistical reasons, Focus cannot be made available both in print and digital versions.
Eliminating the print edition was a hard pill for the Board of Editors to swallow, since we have treasured the print version and felt that it provided a unique format for sharing ideas.
Several concerns about the new format were discussed. How would authors and readers perceive the electronic-only version of their articles? How would we maintain the monthly themes for our issues, the hallmark of Focus? What if someone wants a physical print of an article for references and citation?
It was decided that the format, content and structure of Focus would be maintained, so content can be found and filtered the old way. All of the publication's departments will be maintained, and feature articles will be offered as PDF downloads similar to the currently available online version. Full access to Focus will be limited to RAPS members only.
One primary advantage of the new digital Focus will be the frequent updates about regulatory news and events available to members and non-members alike. While we are nostalgic about the print edition, we believe the new direction will ultimately enable us to provide richer content, more timely delivery and, ultimately, a better product.
In the spirit of the new Regulatory Focus, and to acknowledge the increased importance of international practices, this issue is dedicated to global development. The articles address a variety of topics from a regulatory strategy perspective in developing medical products internationally.
Articles range from medical device development to the preclinical studies needed to support a marketing approval application. There are also two case studies, one on developing products based on a specific technology, nanotechnology and one on wound-care products, that examine the benefits and limitations of international locations for certain development steps.
For medical devices and nanomedicine, international sourcing of several development steps is expected to become a norm for most products. However, only a few common animal and cell culture studies can be conducted at locations outside the US, Canada and Western Europe. Conversely, for wound-care products, practical limitations make international allocation of most critical development steps unlikely.
These articles provide an in-depth analysis of the international product development paradigm in the steps that may apply for all products, apply to specific products, or apply to only a specific class of products. Together, they stress the need for regulatory professionals to think globally but be aware of local requirements. They also underscore the importance of having rapid, easy access to global information.