Welcome to Scientific Depth, i3's online information center that includes access to:

The Innovation Series

Articles, white papers and presentations that provide insight into the science and business of clinical research.

i3 InLine

Current and back issues of our monthly newsletter that presents unique i3 insights plus a summary of the top news impacting the pharma industry.

Engage

Current and back issues of our online newsletter offering timely insight into career matters, hiring practices, and workplace trends for clinical research professionals.

i3 Articles and White Papers

Published work and thought papers written by i3 specialists.

Case Studies

Reports on the results our clients have obtained by drawing on the specialized expertise of i3 scientists, researchers, and associated professionals, or from the use of our data products.

Scientific Presentations and Posters

Login or sign up now to gain access.

i3 InLine Spotlight Article:

With Regulatory Agencies Comparing Notes, Companies Need Coordinated Registration Approach

An increased emphasis on global drug development and safety concerns has prompted regulatory agencies to develop more synergistic relationships that facilitate information sharing. As such, pharmaceutical and biologic companies planning to market their products in multiple countries need to develop registration strategies that account for this new level of regulatory cooperation.

“As 2010 begins, the industry is at a crossroads regarding registration,” according to Anne Tomalin, president, i3 CanReg. “Whereas in the past companies might have wanted to keep one country’s market approval application independent from their applications for that same product in another country, today they are less likely to succeed by taking a jurisdiction-by-jurisdiction approach because those countries are talking to each other about the applications,” she said.

The recent safety focus on drug products has given regulatory agencies a “nice platform” on which to build new processes for sharing information, Tomalin remarked, noting that regulators now attend summit meetings on a routine basis and convene at the International Conference of Drug Regulatory Agencies.

Read the entire article

Sign up now for access to the entire brief!

January 21, 2010
Source: i3 InLine