Klaus

Rose

Pediatric Drug Development & more.

My Story

Blind
Trust

How Parents with a Sick Child Can Escape the
Labyrinth of Lies, Hypocrisy and False Promises

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Recent Publication

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About Me

Klaus Rose

I am a medical doctor by training and profession. After clinical training, I joined the pharmaceutical industry, as I wanted an international job. I was proficient in German, English, Italian, Spanish, and French. I started in a German company headquartered at the Swiss border. In parallel to clinical research on headquarter level, I became also Medical Director Switzerland. These days many Swiss physicians still felt more comfortable speaking in their mother languages German, French or Italian! Today, most speak English, but nevertheless, conversation in the mother tongue usually allows a more intensive conversation.

SERVICES

I provide a wide range of services not limited to:

For Pharmaceutical Companies

Regarding minors, drug developers must deal with two layers of reality: the real world and the regulatory view. FDA and EMA approved drugs for “children” separately, defining “children” as <18 years as if they were another species. The EMA demands a "pediatric investigation plan" (PIP) years before marketing authorization application, the FDA an initial pediatric study plan (iPSP) 60 days after the end-of-phase-2 meeting;

For Lawyers

I describe the abuse of people in medical research in my scientific publications and books now for several years.^1-5 It is numerically the most extensive abuse of humans in medical research since Beecher’s critical article in 1966⁶ and the termination of the Tuskegee study in 1972. This abuse takes place for more than twenty years with the approval of the US regulatory authorities, and since 2007 with the approval of the European Union (EU)..