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Workshop Overview:

There are many issues surrounding the myriad tasks required to set up and efficiently manage clinical studies in the anti-infective area. Small to medium sized companies often possess minimal in-house resource and the skills required for this, often confusing, area of development. Critical issues for each phase of development including the preclinical phase will be discussed and tips provided on how to frame the important questions in order to obtain the right answers.

Who should attend?

Preclinical (e.g.microbiologists and research staff) and clinical development personnel including project /clinical trials managers and medical advisors. Chief Scientific, Chief Medical Officers and CEO's of anti-infective companies. Scientists and licensing executives involved in due diligence activities for companies and venture capital companies.

Benefits of attending the workshop:

This workshop will enebale SMEs to anticipate or identify:

  • Organisational aspects within newly formed organisations or inter-company partnerships
  • Regulatory and developmental challenges associated with novel aspects of many anti-infective agents
  • The importance of product labelling considerations from the earliest development phases
  • Critical learning points and the importance of advanced planning at each developmental stage
  • Typical problem areas during development and risks associated with "quick fixes"
 

 About the workshop leaders:

Richard Bax is a Pharmaceutical Physician with over 32 years of industry experience, including working for Glaxo, Hoechst-Roussel, Lilly and ICI (now AstraZeneca). He was VP at SmithKline Beecham from 1991-1999, working in London and Philadelphia, in charge of Global Anti-infective Clinical Development, resulting in over 15 successful NDAs /MAAs and launches including Famvir/penciclovir, Bactroban and
Augmentin BD. In May 2007 he joined Viropharma as VP Clinical Director Europe and was involved in the set up of the EU company and the EU transplant maribivir phase 3 studies.

 

Flic Gabbay is a pharmaceutical physician with over 25 years of industry experience, including as Global Head of Anti-infectives, at Parke Davis in the US. She has worked for pharma and bio-tech companies in Europe and North America on a range of projects including
monoclonals, transgenics, respiratory, antiinflammatories, lipid lowering agents, anti-infectives and oncology. Flic is Non-executive Chairman of Phico Therapeutics, a novel antibiotic development company and has recently retired from the Board of Directors of Bioanalab after its successful acquisition.

 

Workshop programme

8:30 Welcome and introduction

9:30 The Development Plan

10:30 Coffee

10:50 How do you make a development research department and progress to successful phase I study on a years money?

11:30 The regulatory scene and activities related to the search for new Antibacterials (ECDC/EMEA, IDSA and others)

12:00 Learning by doing

12:30 Sum-up and conclusions

13:00 Close of workshop

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Crowne Plaza Hotel - St James

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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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