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Attrition rates and clinical failures continue to thwart attempts to accelerate new drug development and Chemistry, Manufacturing and Control activities play an important role. Large pharmaceutical companies are rethinking traditional approaches and adopting a flexible strategy to early development. This Masterclass aims to help those working in early drug development to understand the various options open to them and the consequences of their decisions.


 Why should you attend this event?

  • Hear about the latest options for reducing CMC timelines in pre-clinical development
  • Reduce the timeline from development to candidate selection and Phase I studies
  • Understand the consequences of early decisions taken in pre-clinical development
  • Learn from experienced industry individuals with significant knowledge in pre-clinical development

About the Masterclass Leaders:

  Dr. Paul Madeley began his career with Boots Pharmaceuticals in 1977. Later, following his PhD studies, he worked as a development chemist with Courtaulds and then Abbott Laboratories. Since 1995 he has worked in the virtual pharmaceutical arena, first with British Biotech and then with OSI Pharmaceuticals, where he was Senior Director of Chemical Operations, with responsibility for outsourcing, technology transfer, chemical development, scale-up and validation. Paul has worked on over seventy API programmes, covering more than three hundred and fifty synthetic process steps. He set up Synth-Isis Ltd in 2004 to provide consultancy services to virtual pharmaceutical and biotechnology companies around the world. The Company has an extensive network of service providers and consultants who can offer assistance in virtually any aspect of drug development. www.synthisis.com

 


  Dr. Rod Baker is a highly experienced drug development manager with specialist knowledge in CMC from late stage research to marketed products. Rod has over thirty years industrial experience working for a wide range of companies across different industries including agrochemicals, animal health and human healthcare. In the latter field he worked for British Biotech as Head of Pharmaceutical Technology, Avidex as Head of Development & Director of Operations and MediGene as Vice President of Development & Operations. In 2008 he founded Bioedge Pharma Consultancy Ltd, a company offering drug development services to the biotech, pharmaceutical and drug delivery industries. Bioedge works with a wide range of companies at all stages of development and has an extensive network of international service providers and consultants that can offer assistance in virtually all aspects of drug development. www.bioedge.co.uk

 

 


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Masterclass programme

8:30 Registration & Coffee

9:00 A Pharmaceutical Patent is a Rapidly Depreciating Asset

9:40 Candidate Selection and Nomination

10:20 How Much, How Pure, By When?

11:00 Morning Coffee

11:20 Outsourcing to Truncate Timelines

12:00 The First Toxicology Batch

12:40 Lunch

13:40 Subsequent Toxicology Batches

14:20 API Characterisation, Physical Form, Salt Screening and Selection & Polymorphism

15:00 Afternoon Tea

15:20 The First GMP Batch API & Drug Product

16:00 Gathering the Documentation

16:20 Case Study

17:00 Close of Master Class

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Crowne Plaza Hotel - St James

Buckingham Gate 45/51
London SW1E 6AF
United Kingdom

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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