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The workshop will give an introduction into the background of pediatric legislation both in the USA and in the EU. It will further discuss the key differences between the adult and the child’s body, and the consequences in different absorption, distribution, metabolisation and excretion (ADME) in the different age groups. Furthermore, we will go together through the EMA pediatric website and explain where to find key documents, key decisions, and more. Last not least, we will discuss how to prepare and negotiate a pediatric investigation plan (PIP), and what can be done if the pediatric committee (PDCO) insists on requests although they are unfeasible, questionable or even unethical

  • Learn about the historical background and the official justifications for the EU pediatric legislation and the PIP system
  • Exchange lessons learned with the instructor and from the dialogue with representatives from other pharmaceutical companies
  • Understand the counterpart’s logic and learn to prepare for a successful PIP negotiation
  • Learn to see the PIP beyond individual negotiation rounds and be aware of strategies for both successful and less desired negotiation outcomes
  • Strengthen and expand your personal network
  • Background of pediatric legislation in the USA and in the EU
  • The child’s body and its physiology
  • The EMA website and its pediatric sub-website
  • Lessons learned from PIP negotiations
  • The way forward for individual companies

Workshop LEADER


Klaus Rose

CEO, klausrose Consulting

Dr. Klaus Rose is CEO of klausrose Consulting, Switzerland, advising on pediatric drug development and how to comply with FDA & EMA pediatric requirements. He first studied Latin
languages & psychology and then medicine. After postgraduate clinical training in General Medicine he joined pharmaceutical industry 1991. He held various positions in R&D and medical affairs, was Global Head Pediatrics Novartis 2001 - 2005 and Global Head Pediatrics Roche 2005 - 2009. After a year with a regulatory consultancy he established his
own business. Dr. Rose is a frequent speaker on international conferences on pediatric drug development and publishes on a regular base. The second edition of “Guide to Paediatric Drug Development and Clinical Research“, co-edited with Professor van den Anker, was released 2010.

klausrose Consulting

Consulting on pediatric drug development for pharmaceutical companies, academic researchers and other institutions. Support in negotiations about pediatric investigation plans (PIPs, EU) and pediatric plans (USA). Publishing and conference presentations on all aspects of pediatric drug development

Workshop programme

10:30 Registration and Coffee

11:00 Opening remarks

11:15 Session 1 Historical Regulatory and Clinical Background

12:00 Session 2 Child Physiology and Clinical Pharmacology

13:00 Break

14:30 Session 3 Pediatric Clinical Trials

15:30 Session 4 The PIP Challenge: Operational Considerations

16:30 Closing remarks

16:45 End of workshop


Holiday Inn Kensington Forum

97 Cromwell Road
London SW7 4DN
United Kingdom

Holiday Inn Kensington Forum

Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 



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CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.


There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.


Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.


Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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