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Welcome to klausrose Consulting

Pediatric drug development is a new regulatory challenge in drug development. Law now requires appropriate consideration of children for every medicine that is to be marketed.  In the past, companies could decide on their own if they wanted to develop their respective medicine in children or not. Since 2003 (USA) and 2007 (EU) such a choice no longer exists. Especially in Europe, new medications will no longer be registered by the EMA (European Medicines Agency) without a paediatric investigation plan (PIP) approved by the EMA paediatric committee (PDCO).   

Dr. Rose has over 20 years professional experience in pharmaceutical drug development, having focused since 2000 on development of medicines in children. As global head of pediatrics in Novartis (2001 – 2005) and in Roche (2005 – 2009) he has been exposed to a multitude of operational, strategic, high-level and hands-on questions in this area. He has established internal pediatric matrix structures in both companies, gave key contribution to accelerate negotiations with FDA to obtain pediatric exclusivity, and has contributed to the successful negotiation of several PIPs in the therapeutic areas of oncology, allergology, cardiology, inflammatory diseases, rheumatology and nephrology. Dr. Rose chairs the EFGCP children’s medicines working party, was the first chairman of the DIA pediatric SIAC as well as of the IFPMA pediatric taskforce, and speaks on a regular basis at international conferences about this and related challenges.

Developing medicines for children is a microcosm within the complex process of general drug development. To deal with it effectively requires adequate training, creative approaches, and a strong international network of specialists.  Dr. Rose was exposed to the scientific, administrative and operative challenges for more than a decade on the job. He is used to working independently, without the requirement for micro-management and supervision whilst still maintaining appropriate levels of communication, input and guidance on direction from clients.

If you seek help,  feedback or operative support, send an e-mail to klaus.rose@klausrose.net or call +41 61 312 0510.  Dr. Rose will listen and give candid feedback. If Dr. Rose agrees with your strategy and tactics, he will tell you. You might also receive critical feedback that you didn’t expect, with reflections how to deal with the situation. Critical feedback from a consultant at an early stage is better than critical feedback on the record from a regulatory authority.