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According to the European Medicines Agency, a paediatric investigation plan (PIP) is "a development plan aimed at ensuring that the necessary data are obtained through studies in children, when it is safe to do so, to support the authorisation of the medicine for children". PIPs have to be submitted by pharmaceutical companies to the Paediatric Committee (PDCO), which is responsible for agreement or refusal of the plan.

This workshop will be a hands-on exercise examining the different stages of Paediatric Investigation Plan (PIP) preparation. Topics will cover a variety of issues and processes such as going through the multitude of forms to fill in when you plan to submit a PIP, the key considerations you need when you initiate the internal PIP preparation within your company, the steps of submitting the PIP to the EMA / PDCO and the pitfalls & challenges that you might be exposed to, the steps of PIP negotiation with the European Medicines Agency and the PDCO, the challenges of PIP execution and reporting its results.


Key Topics:

  • EMA website and the PIP templates to use: letter of intent, application form, non-clinical & clinical study form and others
  • Preparing the content of the PIP and transferring it into necessary documents
  • Letter of Intent, Cover letter, Application Form, Clinical Study Form, etc. 
  • Preparing and sending out CD Roms to PDCO representatives
  • Validation process and avoiding ”landmines”
  • Transition from agreed PIP to execution

Reasons to attend:

  • Paediatric investigation plans are now mandatory for all clinical trials in the EU involving children
  • A strong relationship with the European Medicines Agency can be established through high quality PIP preparation and submission 
  • PIPs help to ensure efficiency and validate study design
  • Regulatory issues and ethics need to be given more attention in paediatric trials and PIPs focus on this


About the Workshop Leader:

 

 

Dr. Klaus Rose is a Principal Consultant at  Granzer Regulatory Consulting & Services and Former Head of Paediatrics at Roche Pharmaceuticals, a position which he held until November 2009. He qualified in medicine in Berlin and completed his postgraduate clinical training in General Medicine in Germany and England before joining the pharmaceutical industry in 1991. He is co-editor of the book Guide to Paediatric Clinical Research, the second edition of which is in preparation. He also serves as chairman to the EFGCP children’s medicines working party and as chairman to the IFPMA Pediatric Task Force

 


 

Workshop programme

8:30 Registration & Coffee

9:00 Operative Challenges before, during and after PIP submission

10:00 Paediatric Homework: Essentials of Paediatric Investigation Plan (PIP) preparation

10:30 Morning Coffee

11:00 The PIP negotiation process with EMEA / PDCO

11:30 Where to find help: EU and US paediatric research networks, CROs, consultancies

12:00 Practical challenges in paediatric clinical trials

12:30 Close of Workshop

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WHAT IS CPD?

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.

CPD AND PROFESSIONAL INSTITUTES

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.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

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.

GLOBAL CPD

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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