Impact of EU and US #pediatric legislation on industry, authorities & academia

In Uncategorized by Caroline Hornby

pediatric drug legislation This article was kindly provided by Dr. Klaus Rose, Managing Director of klausrose Consulting, and was originally published online by American Pharmaceutical Review in December, 2011.

In his article, Dr. Rose takes a closer look at pediatric legislation in both the EU and the US, and how this has impacted the industry as a whole.

Do you want to know more about:

  • Clinical pharmacology vs. pediatric clinical pharmacology
  • EU vs US pediatric legislation
  • Developing a pediatric investigation plan (PIP)

If so, you need to download the article now.

Ultimately, as Dr. Rose states in his article, “drug development without considering children is no longer possible,” and as such it is important to understand pediatric legislation in order to move forward with clinical trials and approval.

Dr. Rose will be participating in the World Pediatric Drugs Congress this coming April. He will be speaking on the topic ‘European pediatric legislation: an evolutionary step or potential roadblock,’ and participating in a panel on ‘Harmonizing pediatric regulation for a global market.’ Register now to hear him and other pediatric drug experts share their insights.