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SMi is proud to announce the launch of their In-Vitro Diagnostics (IVD) event to London in 2017!

With the current uncertain regulatory landscape in the IVD industry, What does the future hold for companies of the IVD industry? A recent report describes total revenues of the the global IVD market will grow from its 2016 level of $61.85bn to $122.9bn by 2027, representing a CAGR of 6.4% during the period 2016 to 2027.*

SMi's In-Vitro Diagnostics (IVD) will prepare you for the challenging times ahead and how to comply with regulatory requirements to ensure direct access to market ensuring the continued growing demand for use and innovation of IVDs over the next decade and beyond.

Topics of discussion the latest update on the IVD regulation, the implementation of the Qualified Person (QP) as well as the increase in requirements for clinical evidence.

* https://www.visiongain.com/Report/1750/Medical-Devices-Leader-Series-Top-In-Vitro-Diagnostics-(IVD)-Companies-2017-2027

 

  • Hear direct feedback and experiences from the FDA on In Vitro registration in USA
  • Direct your questions to ourexpert panel of Notified Body representatives including BSI, UL, LRQA, TUV SUD, LNE/GMED and TÜV Rheinland
  • Learn how the change in classifications will impact industry with UL
  • Hear insights from Ortho Clinical Diagnostics on the increased requirements for post market surveillance
  • Examine the Medical Device Single Audit Program (MDSAP) with Berlin Heart GmbH

Leading IVD manufacturers, regulators, diagnostic companies to allow you to benchmark your companies strategies and allow for an effective industry specific experience exchange.

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;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Sue Spencer

Sue Spencer, Global Service Line Director, UL International

9:10 A closer look at the New EU Regulations on in vitro diagnostic (IVD) devices

Adrian Bartlett

Adrian Bartlett, Medical Devices, EU Policy Manager, MHRA

• Highlighting the main changes
• Key challenges: competent authority perspective
• How to comply with the timelines

9:50 Examining the impact of the change in classifications on Industry

Nick Baker

Nick Baker, Technical Manager-IVD, , LRQA

• What will the change in classifications from annexe 1 and 2 to groups A-D means for IVD manufacturers?
• Managing the change from self-certified to Notified Body approval
• Assessing the benefits that come with change– how the industry can benefit from a harmonised approach to global classifications

10:30 Morning Coffee

11:00 How can IVD manufacturers prepare for the new IVD regulation?

Maurizio Suppo

Maurizio Suppo, Principal Consultant, Qarad Bvba

• Understand the interfaces and what needs to be managed and when
• Understand the impact on products and how to prepare for this
• Understanding the costs in money, people and time

11:40 Direct your questions to our expert panel of Notified Body representatives as well as discussing the below points

• How to prepare for unannounced audits
• How to organise reviews with your Notified Body
• How to manage the increase in scrutiny on technical files – ensure your files are up to your Notified Bodies standard

Sue Spencer

Sue Spencer, Global Service Line Director, UL International

Nick Baker

Nick Baker, Technical Manager-IVD, , LRQA

Dieter Schoenwald

Dieter Schoenwald, IVD Manager, TUV SUD

Erica Conway

Erica Conway, Global Head - IVD, BSI

Julien Senac

Julien Senac, Certification Project Manager , LNE/G-MED

12:20 Networking Lunch

13:20 Conformity assessment routes

Sue Spencer

Sue Spencer, Global Service Line Director, UL International

  • Overview of the conformity routes explain what type examination is
  • Class D scrutiny CS testing by reference lab
  • TF review/ sampling
  • Managing conformity routes during the transition period
  •  

    14:00 ISO 13485: 2016 edition

    • What are the major changes and updates?
    • The impact on manufacturers
    • How to prepare and what to expect

    Julien Senac

    Julien Senac, Certification Project Manager , LNE/G-MED

    14:40 Afternoon Tea

    15:10 How the updated ISO 13485:2016 works towards the QMS requirements of the IVDR

    Erica Conway

    Erica Conway, Global Head - IVD, BSI

  • Outline of the QMS expectations for a manufacturer under the IVDR
  • How these QMS expectations under the IVDR link to ISO 13485:2016
  • How these QMS expectations link to conformity assessment under the IVDR
  • 15:50 CDx Development in the Ever-Changing Global Regulatory Environment

    Hakan Sakul

    Hakan Sakul, Vice President and Head of Diagnostics, Pfizer

  • How pharma works in Precision Medicine in the context of Rx/Dx development guidelines in the U.S.
  • Adjusting to changing regulation in EU and elsewhere
  • Pfizer¹s Rx/Dx development model
  • Educating the patients and health care providers in navigating through Dx testing
  • 16:30 Ensuring compliance with the increased requirements for post market surveillance

    Marta Carnielli

    Marta Carnielli, Senior Manager, Quality Regulatory and Compliance EMEA, Ortho Clinical Diagnostics

    • Impact of the new 15 day limit to report serious incidents to the new central European database
    • Introduction of trend reporting
    • The need to update technical documentation with vigilance data, and making the available to the Notified Body

    17:10 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Chris Dark

    Chris Dark, QARA Director, Arkray Inc

    9:10 Evaluating the need for a dedicated proposal for companion diagnostics in the new IVD regulation

    Frank  Breitenbucher

    Frank Breitenbucher, Project Manager Companion Diagnostics, Tuv Rheinland

    • Has a final text been agreed upon by parliament for the requirements for companion diagnostics?
    • Understanding the specific requirements of market approval for companion diagnostics in the draft regulation
    • Successfully transitioning from being self-certified to being certified by a Notified Body

    9:50 The impact of the new regulations on IVD’s already on the market

    Dieter Schoenwald

    Dieter Schoenwald, IVD Manager, TUV SUD

    • What will happen to products previously classed as low risk that are now subject to being listed as high risk?
    • What updates will be needed to keep them as CE marked IVD’s?
    • How will the involvement of the notified bodies change – will these IVD’s be brought into the scope of conformity assessment?

    10:30 Morning Coffee

    11:00 KEYNOTE ADDRESS: In-vitro Diagnostic Regulation in USA

    Alberto Gutierrez

    Alberto Gutierrez, Director of Office of In Vitro Diagnostics and Radiological Health, Food and Drug Administration

    • In-vitro diagnostic classification, pre-market and post-market requirements in USA
    • Product life cycle: Modifications and new product development
    • Prescription vs Over the Counter requirements
    • Laboratory regulations and its effect on diagnostic devices
     

    11:40 The in-vitro diagnostic market in the Middle East

    Amir Hassan

    Amir Hassan, Regulatory Affairs Manager, Lifescan (J&J)

    • Examining how Saudi Arabia has the most restricted regulation in comparison to the rest of region
    • The challenges that the Middle East face with understanding the regulation
    • The issue of counterfeit products

    12:20 Networking Lunch

    13:20 In Vitro diagnostic regulations in Asia/ASEAN

    May Ng

    May Ng, Director, ARQon Asia Regulatory & Quality Consultancy

  • How IVD being controlled in selected market in Asia and ASEAN
  • The challenges for companies understanding the Asia and ASEAN countries regulation.
  • Asia & ASEAN harmonization initiatives and happenings
  • 14:00 Identification, traceability of devices and UDI implementation

    Ulrike  Kreysa

    Ulrike Kreysa, Vice-President Healthcare , GS1

    14:40 Afternoon Tea

    15:10 IMDRF MDSAP program (Medical Device Single Audit Program with the involvement of the following Authorities: Japan, Australia, Brazil, Canada, USA-FDA)

    Hendrik Heinze

    Hendrik Heinze, Director Quality and Regulatory Affairs, Berlin Heart A G

    • Experiences from the pilot phase of the program
    • Experiences in your first MDSAP audits
    • Overcoming the challenges and looking to the future

    15:50 Best strategies and approaches to meeting the requirements for clinical evidence

    • How to compile an accurate clinical evidence report
    • How to effectively comply with the increased requirements for regulatory authorities
    • Ensuring clinical evidence is kept up to date during the life time of the device

    Alex Laan

    Alex Laan, Principal Certification Manager, Dekra

    16:30 IVDR scope expansions: Economic operators

    Chris Dark

    Chris Dark, QARA Director, Arkray Inc

    • Impact on operators
    • Impact on manufactures– how to deal with operators in such a precise way
    • Opportunities and challenges associated

    17:10 Chairman’s Closing Remarks and Close of Day Two

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    FEATURED SPEAKERS

    Adrian Bartlett

    Adrian Bartlett

    Medical Devices, EU Policy Manager, MHRA
    Alberto Gutierrez

    Alberto Gutierrez

    Director of Office of In Vitro Diagnostics and Radiological Health, Food and Drug Administration
    Sue Spencer

    Sue Spencer

    Global Service Line Director, UL International

    Adrian Bartlett

    Medical Devices, EU Policy Manager, MHRA
    Adrian Bartlett

    Alberto Gutierrez

    Director of Office of In Vitro Diagnostics and Radiological Health, Food and Drug Administration
    Alberto Gutierrez

    Alex Laan

    Principal Certification Manager, Dekra
    Alex Laan

    Amir Hassan

    Regulatory Affairs Manager, Lifescan (J&J)
    Amir Hassan

    Chris Dark

    QARA Director, Arkray Inc
    Chris Dark

    Dieter Schoenwald

    IVD Manager, TUV SUD
    Dieter Schoenwald

    Erica Conway

    Global Head - IVD, BSI
    Erica Conway

    Frank Breitenbucher

    Project Manager Companion Diagnostics, Tuv Rheinland
    Frank  Breitenbucher

    Hakan Sakul

    Vice President and Head of Diagnostics, Pfizer
    Hakan Sakul

    Hendrik Heinze

    Director Quality and Regulatory Affairs, Berlin Heart A G
    Hendrik Heinze

    Julien Senac

    Certification Project Manager , LNE/G-MED
    Julien Senac

    Marta Carnielli

    Manager II, Safety Risk Manager & Surveillance & Distribution Quality, Ortho Clinical Diagnostics
    Marta  Carnielli

    Maurizio Suppo

    Principal Consultant, Qarad Bvba
    Maurizio Suppo

    May Ng

    Director, ARQon Asia Regulatory & Quality Consultancy
    May Ng

    Nick Baker

    Technical Manager-IVD, , LRQA
    Nick Baker

    Sue Spencer

    Global Service Line Director, UL International
    Sue Spencer

    Ulrike Kreysa

    Vice-President Healthcare , GS1
    Ulrike  Kreysa

    Sponsors and Exhibitors

    Supporters

    Workshops

    A roadmap to implement EU-IVDR compliance program
    Workshop

    A roadmap to implement EU-IVDR compliance program

    Holiday Inn Kensington Forum
    13th June 2017
    London, United Kingdom

    [SPEAKER INTERVIEW] - Ulrike Kreysa, Vice-President, GS1 Global

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    [SPEAKER INTERVIEW] - Chris Dark, QARA Director (EMEA), Arkray

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    2017 Preliminary Attendee List

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    Sponsors and Exhibitors


    Qarad

    Sponsors and Exhibitors
    http://www.qarad.com/

    Qarad is a consulting company, specialized in European regulations and quality system implementation for IVD and Medical Devices. Qarad assists a.o. in the creation of technical documentation and organizes performance evaluations. Qarad offers a unique solution for e-IFU, already used by both small and multi-billion-dollar Medical Device and IVD companies.


    Q-Pulse

    Sponsors and Exhibitors
    http://www.ideagen.com

    Q-Pulse, an electronic quality management system, supports medical device and in-vitro diagnostic manufacturers with key business functions to ensure quality, reliability and safety are achieved throughout the product lifecycle. Our solutions encourage adoption of a risk-based approach to compliance management, giving you the confidence that your products and services are safe and fit for purpose.

    Media Partners


    MDPI Diagnostics Journal

    Supporters
    http://www.mdpi.com/journal/diagnostics

    Diagnostics (ISSN 2075-4418) is an online, peer-reviewed, open access journal on the research and development of medical diagnostics, including nuclear medicine, medical imaging, molecular diagnostics, biomarkers, clinical decision support systems, lab-on-chip, microfluidics and novel diagnostic devices. The scientific community and the general public have unlimited and free access to the content as soon as it is published. We would be pleased to welcome you as one of our authors.


    Pharmalicensing

    Supporters
    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique Partnering Search service and its global network of industry experts to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing, and its sister service Medical Device Licensing (www.medicaldevicelicensingcom) are actively utilized by over 200,000 industry professionals each month. Pharmalicensing is a division of IP Technology Exchange, Inc.


    Inderscience Publishers

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    Inderscience is a dynamic, leading, independent journal publisher. The company disseminates the latest research across the broad fields of science, engineering and technology; management, public and business administration; environment, ecological economics and sustainable development; computing, ICT and internet/web services, and related areas. Inderscience offers over 35 years' experience in publishing and has succeeded in building a substantial collection approaching 400 high-quality peer-reviewed international research journals in both online and print formats. We offer a variety of ways to keep up-to-date with the latest published leading-edge research while our online collection represents a fully-searchable digital archive of around 60,000 articles.


    Farmavita

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    http://www.farmavita.net/

    Farmavita Net is professional community and network of pharmaceutical licensing and business development executives, innovators and researchers
    Farmavita.Net is the pharmaceutical licensing, technology transfer and regulatory affairs network. We are managing the marketplace of offers and demand for pharmaceutical Dossiers, know-how and technologies. Members of Farmavita.Net network usually find a number of attractive solutions for business development, alliances, joint ventures, co-development and co-marketing of pharmaceutical products. Farmavita.Net is not just a pure Internet portal. We manage a number of regional associates. We are connecting the dynamic network of few hundreds members / pharmaceutical companies interested in license-in and license-out opportunities.


    Bio-Equip

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    http://www.bio-equip.cn/

    Established since 1998, Bio-Equip is a leading website for lab equipments, reagents, consumables and bio services. Our users come from different fields like life science, medical research, pharmaceutical, biotechnology, modern agriculture, food safety and environment monitoring. Bio-Equip offer users a complete product directory which involves 158 product ranges among lab equipments, reagents, consumables, lab animals, bio services, cell lines, bio software and books.Serving users through two websites, www.bio-equip.com (Chinese) and www.bio-equip.cn (English), we own over 20,000 registered suppliers and more than 500,000 pieces of product and technical service information with details of product description, price, sample downloading, technical articles and videos.


    BioChem Adda

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    BioChem Adda is a Not-just-for-Profit organization which aims to bring out the most reliable and transparent information about everything related to jobs, careers, education, news, articles, and events from the field of BioSciences and Chemistry!


    European Pharmaceutical Review

    Supporters
    http://www.europeanpharmaceuticalreview.com

    European Pharmaceutical Review is the leading bi-monthly technical journal for the pharmaceutical industry, and essential reading for anyone involved in drug discovery or manufacturing. Every issue offers a high level of technical and business contributions from the world's leading pharmaceutical companies and academic institutions, keeping readers up-to-date with new developments and projects within the dynamic European pharmaceutical environment and featuring articles on topics that impact the sector, including: – cellular imaging, drug discovery, microbiology, stem cells and toxicology. The strength of European Pharmaceutical Review is reflected by our circulation figures, with an estimated 30,000 readers across the globe.


    Swiss Biotech Association

    Supporters
    http://www.swissbiotech.org/

    The Swiss Biotech Association (SBA) is the national industry association for biotechnology, including pharmaceuticals, diagnostics, agriculture, food, cosmetics, environmental biotechnology, and specialty chemicals. Members are companies active in modern biotechnology, such as R&D, Production, Marketing and Sales, Finance, Services and Consulting. SBA provides a networking platform for Life Science clusters, academic and federal institutions the like. Founded in March 1998, the Association grows steadily.


    Biosave

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    Biosave.com brings together the best Life Science promotions, product releases, featured products, publications, videos and events from 100’s of leading Life Science suppliers. Updated 24 hours a day, Biosave is constantly uploading special promotions and exciting product news that you won’t find anywhere else. Our goal is to provide our users with the most exclusive product information to help reach that all important purchasing decision.


    Pharmacircle

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    http://www.pharmacircle.com

    PharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….


    Gate2Biotech

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    http://www.gate2biotech.com

    Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.


    Pharmaceutical-Review

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    http://www.pharmaceutical-review.com

    Pharmaceutical-review.com is part of Integrated IQ technologies Private Limited(IIQ). A Leading platform for all the Pharma manufacturing companies and buyers across the world.Having a subscriber database of more than 120,000 globally helping the clients to reach their target buyers through our exclusive listing, branding(banner advertisement), e-news letters, e-mail marketing, product reviews, product launch promotions, event marketing, search engine marketing and social media marketing services.


    Pharmaceutical Technology

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    Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


    International Journal of Biotechnology

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    IJBT provides an international forum and refereed authoritative source of information in the field of Biotechnology and Biotechnics, with emphasis on management and economics, as well as the political and social issues. It aims to disseminate knowledge, provide a learned reference in the field, and establish channels of communication between academic and research experts, policy makers and executives in industry, commerce and investment institutions.


    Select Science

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    SelectScience is an independent, online information resource for the worldwide scientific community, and the home of trusted information for laboratory scientists. Discover impartial, expert opinion and trusted reviews about latest laboratory equipment and techniques; plus videos, application notes and science news from around the world. Become a member for free today.


    Technology Networks

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    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    Drug Development Technology

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    Drugdevelopment-technology.com covers every aspect of the drug development and research process, from conception to pre-FDA approval. Our global network of journalists updates the site with the latest and most significant industry developments. This coverage allows us to provide everyone - from senior management through to research and QA staff – with in-depth reviews of the latest projects, advance notice of new product releases and analysis of the latest procedural and legislative developments.


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    PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.


    Absave

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    Absave.com is the leading savings website for Antibodies and Immunological Products. Search our extensive database of Antibodies, Kits, Proteins & Peptides, Reagents, etc. to find the best savings!


    International Pharmaceutical Industry

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    Drug Discovery Today

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    Drug Discovery Today is one of the most cited review journals in the field of drug discovery, with an impact factor of 6.422.
    Drug Discovery Today will benefit your research by helping to keep you up-to-date with all of the fast-moving and emerging topics in drug discovery. Each issue is packed full of the latest research news, peer-reviewed articles and comment and opinion from leading research scientists.


    Labsave

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    Labsave is the leading savings website for Laboratory Equipment and Lab Supplies. We work closely with the top suppliers in the world to bring you the best products at the most competitive prices. We are constantly striving to secure the biggest and most exclusive offers that you won’t find anywhere else! http://www.labsave.com/


    International Journal of Healthcare Policy

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    IJHP serves as a forum for interdisciplinary discussion of leading issues in healthcare law, medicine and health policy. Emphasis is placed on issues such as legislative and regulatory environments, and plans and actions that are undertaken by organisations and agencies to achieve specific healthcare goals within society. This perspective is reflective of the broad range of efforts to advance the public's health.

    Holiday Inn Kensington Forum

    97 Cromwell Road
    London SW7 4DN
    United Kingdom

    Holiday Inn Kensington Forum

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South 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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