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Today, approval for NDA's is no longer assured upon completion of Phase III trials and research shows the FDA is now requiring post-marketing studies in over 70% of cases to prove a drug's long-term efficacy and safety. The situation is compounded by increasing costs – the average cost is now approaching the $4 million mark - to carry trials to phase III and beyond, difficulties with patient and clinician retention and much more.
The SpeakersTo answer these concerns and to provide attendees with an essential industry update, the SAE Media Group has produced a strategic event that will be delivered by an excellent panel of industry leaders, including:
Why should I attend?The conference will address your key concerns in a practical forum and give you the opportunity to explore how companies are:
Who should attend?
Hugh Levaux, Vice President, Product Strategy, Medidata
Michael Kafrissen, Chief Scientific Officer, Scientific Affairs, Ortho-Mc Neil Janssen Scientific Affairs, LLC
Gurdyal Kalsi, Director, Medical Affairs and Pharmacovigilance, MDS Pharma Services
Anne Kehely, Medical Advisor, Global Product Safety, Oncology/ID , Eli Lilly
Glenn Matfin, Head, Medical Affairs, Novo Nordisk Inc.
David Provost, Senior Executive Director, Post-Approval Strategic Operations, Pharmaceutical Product Development, Inc.
Christian Grøndahl, Vice President, eClinical Global Development, Novo Nordisk
Mason Diamond, Vice President, Clinical and Regulatory Affairs, TyRx Pharma
Francis Crawley, Director General, Good Clinical Practice Alliance
Wolfgang Schumann, Senior Medical Safety Advisor, Bayer-Schering Pharma
Ferdinando Emanuele Vegni, Director, Risk Management Strategy, World Wide Development, Pfizer
Nawab Qizilbash, Honorary Senior Lecturer in Epidemiology, Imperial College, London University, Consultant Geriatrician Member, Green College, Oxford University[Formerly, Director of Epidemiology, GlaxoSmithKline, 1997-2005], Oxon Clinical Epidemiology
Bil Duval, Vice President, Global IIIb/IV Operations, Quintiles Strategic Research
Brian Leiser, Vice President, Late Phase Strategy, Medidata
Sebastian Iovan, Director, Health Economics Central and Eastern Europe, Eli Lilly & Company
Michael Herschel, Director, Clinical Research, GlaxoSmithKline
19 New Bridge Street, London, United Kingdom
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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, SAE Media 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.
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@saemediagroup.com
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