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What is this event about?

 

Paediatric Investigation Plans (PIPs)  are mandated by the European Medicines Agency (EMA) to ensure that medicines for children are included in the mainstream drug development process in Europe, rather than as an optional extra. This means that children benefit from more effective treatments and pharmaceutical companies will be rewarded for increased time and costs relating to paediatric drug development.


The Regulation (EC) 1901/2006 Medicinal Products for Paediatric Use, entered into force on 26 January 2007 and caused a massive paradigm shift in European drug development. Pharmaceutical companies must submit a Paediatric Investigation Plan to the Paediatric Committee (PDCO) at the EMA around the end of Phase One new drug testing in adults. But studies for children are different and require a huge amount of collaboration.


This Masterclass aims to present a holistic approach addressing the challenges encountered during the creation and life span of a PIP. Often legal, clinical and regulatory departments are in widely different locations. These personnel have their own specialist focus but may not appreciate the roles of and synergy needed between other teams. This is  essential for producing successful PIPs  and the paediatric studies they must perform to legally binding timelines.


We are excited that our  Masterclass will be delivered through a combination of diversely skilled speakers who will give presentations, case studies and discussions. This is designed to help inspire delegates with an understanding of and a synergistic approach for successful paediatric drug development.

 

 

Where is the event?

This Masterclass will take place in central London, UK

 

Who would benefit? 

Professionals from a variety of departments within Pharmaceutical and Contract Research Companies such as:


Corporate
Clinical Operations
Legal and Regulatory Affairs
Paediatric Project Teams
Quality and Ethical Assurance

  In association with

 

 

By attending this event you will be better able to:

Identify and address challenging issues within your PIP
Develop your understanding of the preparation process
Think “out of the box” for successful paediatric drug development
Link regulatory and clinical expertise for a joined up approach
Discover ways to further improve your current approach
Expand your network of paediatric colleagues and contacts

 

Who is leading this event? 

Jane Lamprill, RN RSCN FICR Director,

Paediatric Research Consultancy 

Jane has 17 years experience as a Paediatric Research Sister (Senior Study Site Coordinator) managing both pharmaceutical and academic paediatric clinical trials. She founded Paediatric Research Consultancy in 2004 near Oxford UK. Her current roles are mainly 1) advising companies about practical, ethical and study management issues 2) providing informed consent/assent materials as a specialist children’s medical writer 3) Ethics review as member of the FP7 European Commission ethics panel 4) In-company training.

Co-hosted by Steve Pinder, PHD, MTOPRA, Co-Director, Envestia

   


Steve Pinder qualified in biochemistry before completing a PhD and post-doctoral work in molecular genetics.  He began his regulatory career in 1992 with Smith & Nephew before joining Chauvin Pharmaceuticals where he managed clinical research and drug safety functions in addition to the regulatory team.

In 2007 Steve founded Envestia Ltd with business partner Dr Ian Dews, a pharmaceutical physician and former full-time clinical investigator.  Envestia is focused on clinical drug development and regulatory affairs, encompassing drug development planning, scientific advice, orphan drugs, paediatric investigation plans and training plus all types of regulatory / medical writing including clinical overviews and summaries.
 

 

We are also pleased to include as speakers:

Lorna Brazell, Solicitor for Bird&Bird 

Lorna’s practice focuses on intellectual property protection and enforcement across a range of industries including pharmaceuticals and biotechnology, and in recent years she has also developed expertise in pharmaceutical regulatory matters in Europe.  She is experienced in the management of litigation across multiple jurisdictions. 


Jeremy Hague, European Business Development Manager,Xceleron

Since joining Xceleron in 2003, Jeremy has been instrumental in developing fit-for-purpose applications of 14C tracer/AMS in clinical investigations. Jeremy combines a keen understanding of client need across a range of pharmaceutical stakeholder groups with a broad knowledge of how 14C tracer / AMS can be used to design novel and cost-effective clinical studies


Tony Hall, Chief Medical Officer & Christa van Kan, Director of Clinical Operations,PSR Group, The Netherlands

Tony Hall graduated in London with first class honours in physiology & pharmacology from King's College then as a doctor at the Royal Free Hospital. He specialised in Emergency Medicine and joined the pharmaceutical industry in 1994. At Boehringer Ingelheim he was responsible for the strategic development of many clinical programmes and for two global products. He worked at Yamanouchi before starting his own business.

Now as Chief Medical Officer of PSR, Tony has an in-depth knowledge of the orphan drug market, applicable regulations and procedures.  He provides advice and guidance on development plans for orphan drug designation, protocol assistance and clinical programmes. He has built trusted relationships with patient groups to help ensure their voice is heard during PSR’s clinical trial involvement.
 

Christa van Kan has over 15 years experience in managing clinical trials (mainly phase II - IV) in a broad range of indications. In addition to her master's degree in biomedical sciences, Christa has gained a postdoc degree in clinical epidemiology. Christa co-founded her own CRO in 1998, and is currently co-owner and Director Clinical Operations of PSR. In this position, she is responsible for overseeing all clinical trials performed by PSR, a CRO which focusses on orphan drug and pediatric trials. On the basis of her experience, Christa is very much aware of the challenges of performing trials in children or patients with rare diseases and can offer practical advise on how to bring such studies to a successful end.

  

 

Our Masterclasses are all CPD accredited, offering you measurable value as part of your continued professional development

 

Masterclass programme

9:00 Registration & Coffee

9:20 Welcome and introductions

Jane Lamprill

Jane Lamprill, Paediatric Research Consultant Specialist Medical Writer for Children and Member FP7 Ethics Panel, Paediatric Research Consultancy

9:35 Planning your PIP

Steve Pinder

Steve Pinder, Director, Envestia

•       PIP experience so far
•       How to write a PIP
•       Considerations for deferrals and waivers
•       Regulatory update for PIPS and EMA
•       Brief pediatric FDA update
•       Helping to make your PIP work for you
•       Current issues affecting PIPs
 

11:00 Morning Coffee

11:30 Child and Company friendly technology

Jeremy Hague

Jeremy Hague, Director of European Business Development, Xceleron Ltd

•       Gaining PK and Metabolism from small clinical samples using breakthrough ultra-sensitive analytics

12:00 Clock Stop - Considerations for PDCO

Jane Lamprill

Jane Lamprill, Paediatric Research Consultant Specialist Medical Writer for Children and Member FP7 Ethics Panel, Paediatric Research Consultancy

•       Don’t promise what you cant deliver!
•       Practical planning for smooth studies to bridge gap between PIP and family
•       Ethical issues when planning paediatric trials and agreeing  PIPS

12:45 Networking Lunch

13:45 Putting PIP studies into action - linking theory to practice

14:30 Legal update for 1901/2006/EC

Lorna Brazell

Lorna Brazell, Partner, Bird & Bird

•       Overview of legal issues relating to the PIP and the patent extension reward

15:15 Afternoon Tea

15:30 Q&A panel discussion; PIP problem solving

Jane Lamprill

Jane Lamprill, Paediatric Research Consultant Specialist Medical Writer for Children and Member FP7 Ethics Panel, Paediatric Research Consultancy

Lorna Brazell

Lorna Brazell, Partner, Bird & Bird

Steve Pinder

Steve Pinder, Director, Envestia

Jeremy Hague

Jeremy Hague, Director of European Business Development, Xceleron Ltd

16:15 Key take home messages. Thanks and close of Materclass

Jane Lamprill

Jane Lamprill, Paediatric Research Consultant Specialist Medical Writer for Children and Member FP7 Ethics Panel, Paediatric Research Consultancy

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Harrington Gardens
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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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