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Much is happening globally in the world of antibiotic research, development, licencing and use. The paucity of new antibiotics for the effective treatment of multidrug gram negative infections over the last 10 years coupled with the inexorable rise of these organisms has led to claims for a disaster soon to happen. This has been likened to the global effects of climate change but this bacterial threat is already causing increased morbidity and mortality. Many proposals have been made by a large number of stakeholders including researchers, developers, regulatory bodies and payers recently.

This masterclass will deal with issues related to the opposing forces of investment, research and development when constructing a commercial forecast for a novel agent.
 

Target Product Profile: The importance of originators providing information on assets to realistically delineate the boundaries of a forecast.
Understanding the True Competitors: Focus on under recognised competitor assets/interventions with future transformational potential for market growth or shrinkage when looking at competitors to a small molecule or novel therapy approach.
Impact of Companion Diagnostics: The upsides and downsides of rapid diagnostics when forecasting future market potential for broad or narrow spectrum agents.
Pricing & Reimbursement: Thoughts on premium pricing and ways to justify value in the future antibacterial market environment. Is a limited patient population always required for premium pricing?
Clinicians Approach: Understanding the unmet needs facing practicing clinicians and innovative use of treatments to provide a successful outcome for their patient today, that can be the future growth areas for novel approaches.

  • US and EU regulatory environment – yesterday, today and tomorrow ?
  • Similarities and differences – US and EU ?
  • Current and planned guidelines for antibiotics?
  • Regulatory opportunities and incentives ?
  • Working with the regulators to deliver new drugs in a changing environment

You should attend this master class if you want to:

Understand the global situation and the medical need ?
Identify value added activities and regulatory needs ?
Consider some of the push/pull incentives available for the right antibiotic ?
Learn how to create early phase product development that achieve early regulatory approval ?
Become aware of the importance of valuing the asset early and how to achieve higher pricing for limited populations

Masterclass programme

8:30 Registration & Coffee

9:00 Welcome & Introduction

9:10 Overview of antibiotic R&D issues

Richard Bax

Richard Bax, Senior Partner, TranScrip Partners

9:45 Regulatory challenges & opportunities in antibiotic drug development & registration

Gareth Walters

Gareth Walters, Senior Partner, TranScrip Partners

10:20 Coffee Break

10:50 Issues with forecasting the unknown

Tim Joslin

Tim Joslin, Senior Partner, TranScrip Partners

11:25 Round Table

12:00 Closing Remarks

12:30 End of Workshop

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Holiday Inn Bloomsbury

Coram Street
London WC1N 1HT
United Kingdom

Holiday Inn Bloomsbury

Holiday Inn London-Bloomsbury is just 2 minutes' walk from the Tube at Russell Square station, for speedy connections across the capital. We're 10 minutes by bus from Eurostar connections at St Pancras station, and a 45-minute taxi ride from London Heathrow Airport. Check into your stylish Guest room, air-conditioned and connected to wireless Internet.

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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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