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This workshop, led by the expertise of Sohail Chohan of ERA consulting will provide attendees with a unique understanding of the current regulatory expectations for Antibody Drug Conjugates. Attendees will be presented with an in-depth analytical perspective in the CMC and quality requirements laid out by the EU and will work with the group to develop effective CMC strategies. This case-study led workshop will provide attendees with a comprehensive overview of regulatory development of ADCs.

Why you should attend:

  • Analyse current guidelines provided by the EU and learn how best to translate these legislations
  • Discuss ideas to overcome current obstacles in CMC requirements for ADCs
  • Develop strategies for Phase 1 Clinical Studies
  • Network with key industry professionals 
 

  

 

About the Workshop Hosts: This workshop will be led by Dr Natalie Thomas and Kathleen Dawes, Regulatory Affairs Project Managers, ERA Consulting.

 
   

About ERA Consulting: ERA Consulting are an international organisation providing consulting services in product development and regulatory affairs with particular expertise in the field of biotech and other biological products, innovative NCEs and biomarkers. Over the past 22 years, they have assisted clients from all over the World to achieve efficient and expedient regulatory approvals in Europe, the USA and Australasia. Their clients range from the largest pharmaceutical companies to biotech start-ups and investment groups and their proven track record places them in an unrivalled position as consultants in these fields and provides a level of expertise and experience from which all their clients can benefit

 

   

 

Workshop programme

13:00 Registration & Coffee

13:15 Welcome & Introductions

13:30 Current EU Legislation & Guidelines

14:15 Introduction and Overview of CMC Requirements for ADCs and Key Guidelines

15:00 Afternoon Tea

15:15 Pre-clinical Requirements for Phase 1 Clinical Studies

16:00 Regulatory Strategy for ADC Development

16:30 Case Studies and Group Task

17:30 Close of Workshop

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VENUE

Holiday Inn London - Kensington

Wrights Lane, Kensington, London, W8 5SP, United Kingdom

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Holiday Inn London - Kensington

Wrights Lane
Kensington
London
United Kingdom

Holiday Inn London - Kensington

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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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