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SMi is proud to announce the launch of their Medical Devices and IVD post-conference workshop to be held in London on 17th November 2021.

SMi's inaugural Medical Devices and IVD conference will provide insight into the latest updates in EU MDR and IVDR regulations and will discuss strategies for how to best comply with these new regulations. In addition, the conference will examine MHRA Guidance on Post-Brexit IVD Regulations and consider the evolving regulatory landscape for digital health software. Join Europe’s leading Medical Device and IVD Conference which will address post-market surveillance and vigilance, clinical evaluations and investigations, medical device regulatory affairs in global markets, and much more.
 

The workshop will examine major implementation workstreams for MDR with an emphasis on effective implementation methods. The presenter will explain how early analysis of the text, though difficult is crucial to dealing with change. How to plan in absence of guidance. How identification of significant changes is crucial to planning and prioritization and ultimately how partitioning Article 117 provisions from those implemented for MDR may be beneficial. A discussion of the impact of new economic operator obligations on industry partners with no previous role in the regulated framework. Ambiguities created for distributors of non-integral drug device combinations. The presenter will discuss how to manage multiple implementation projects through to the accreditation process and CE marking.

Any organization with an interest in CE Marking or struggling with implementation for MDR or even IVDR may benefit from the approach described for implementation. The discussion of Article 117 would be of particular interest to any organization which has not yet been in a position to obtain a Notified Body Opinion.

Executives, Directors, VPs, Heads, Principals, Managers of:

  • Device Manufacturing
  • Regulatory Affairs
  • IVDR
  • MDR
  • CMC
  • Compliance
  • Risk Management
  • Traceability
  • Vigilance
  • Product Development
  • PFS
  • Combination Products

Previous attendees include:
 

Adams Business Associates; Alere International; Alere UK (Rebranded from Inverness Medical UK); AstraZeneca; Bayer A G; BIOAXXESS Technology; Biokit S A; BioKit SA; Boehringer Ingelheim Microparts Gmbh; Cambridge Isotope Laboratories Inc.; Euro Diagnostica; Fleet Bioprocessing Ltd; Index Ventures; Innovate UK (formerly:Technology Strategy Board); Integrated Medicines; Irish Medicines Board; Life Technologies; Medical Device Consultancy; National Genetics Reference Lab, Manchester; NHS Innovations London; NHS Institute for Innovation and Improvement; Pharma Ventures; Point-2-Point Genomics Ltd; QuantumDX; Quotient Bioresearch; Roche Diagnostics Ltd; Royal Free Hospital; Scientia Advisors; Simon-Kucher & Partners; Technology Networks; Unilabs France; University of Birmingham; University of Edinburgh;
 

FEATURED SPEAKERS

Blake Green

Blake Green

Senior Manager Regulatory Affairs, Amgen

Blake Green

Senior Manager Regulatory Affairs, Amgen
Blake Green

Blake Green is a Regulatory Affairs Senior Manager with Amgen’s Global Medical Devices Regulatory team. Based in Cambridge UK. Blake is a Devices Regulatory lead for medicinal product/medical device combination products and co-packaged medical devices in the biopharmaceutical sector. Prior to joining Amgen, Blake had significant international experience securing multi-national market clearance for manufacturers of medical devices, medical device/medicinal product combinations, medical software, personal protective equipment, and biocides, located throughout the United States of America, European Union, North Africa, Middle East, Far East, Turkey, Israel, Australia, Canada, and Peoples Republic of China.

VENUE

Venue To Be Confirmed

London, United Kingdom

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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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