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** MANAGER'S SPECIAL RATE ** - REGISTER TODAY FOR ONLY £1,099! **

Although an old process, Pharmaceutical Freeze Drying is ever evolving with new trends and approaches being used for pharmaceutical formulation. The 6th Annual Pharmaceutical Freeze Drying Technology conference will cover the most recent advances in Freeze drying technology and discuss the latest ideas in the industry. Join us in June, to explore new approaches to prediction and analysis, alternative freeze drying technologies and overcome the challenges of freeze drying technology.
 

Benefits of attending

  • Evaluate mathematical models for scale up and transfer
  • Consider what is important when choosing the correct excieptent
  • Explore ways of prediciting protein stability and analysing on-line impedance
  • Assess the benefits and challenegs of continuous freeze drying
  • Discuss what is acceptable when looking at cake appearance

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VPs, Directors, Chiefs, Heads, Principals, Managers and Analysts of:

• Freeze-drying/ Lyophilisation
• Formulation Scientist
• Bioprocessing
• Process Development
• Sterile/ Fill-Finish
• Production
• PAT
• CMC
• Chemistry
• Manufacturing
• Quality Assurance/QA
 

Abbott Healthcare Products BVá; Baxter SA; Bayer A G; Biofire Diagnostics; Biopharma Group; BioPharma Technology; Boehringer Ingelheim; Boehringer-Ingelheim; Bristol-Myers Squibb; BSP PHARMACEUTICALS Srl; BUCHI UK Ltd ; F. Hoffman-La Roche Ltd.; GEA Process Engineering; Genzyme Ireland Ltd; GlaxoSmithKline; GlaxoSmithKline plc; GSK; GSK Manufacturing S.p.A.; Hosokawa Micron BV; Imperial College London; INDATECH SAS; Janssen Pharmaceutica NV; MedImmune; MedImmune Inc.; Merck KGaA; Mylan; NIBSC; Novo Nordisk; OPTIMA pharma GmbH; Pacifi Ltd; Pfizer Inc; Roche; Roche Pharmaceuticals; Sandoz GmbH; Syngenta Limited; TEVA Pharmaceuticals; University College Cork (UCC); University Of Central Lancashire; Vetoquinol SA; Xellia Pharmaceuticals ApS;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Sune Klint  Andersen

Sune Klint Andersen, Principal Scientist Spray Drying , Janssen Pharmaceutica NV

9:10 Freeze drying of biologics: The essentials

Patrick  Garidel

Patrick Garidel, Process Sciences Department, Head of Pharmaceutical Basic Development, Boehringer-Ingelheim

  • Short introduction to the freeze-drying process
  • Freeze-dried market products
  • Biologics in the dry state: what to consider?
  • Formulation principles for freeze-dried products
  • Process development of freeze-dried products
  • Primary packaging for freeze-dried products
  • Analytics for the characterisation of lyophilizates
  • Stability issues
  • 9:50 Freeze drying process optimization for the purpose of industrial transfer

    Mostafa Nakach

    Mostafa Nakach, Head of Pharmaceutical Engineering Group, Sanofi-Aventis R&D

  • Characterization of heat transfer coefficient with and without tray
  • Process Optimization by using numerical simulation
  • Application to product to be transferred
  • 10:30 Morning Coffee

    11:00 Use of old and new methods in optimising freeze drying cycles

    Paul Matejtschuk

    Paul Matejtschuk, Principal Scientist, NIBSC

  • Illustrate how existing technologies can be used
  • New and experimental methods are adding to our capabilities.
  • Off- line dynamic mechanical analysis
  • On-line impedance analysis
  • 11:40 Optimisation of industrial freeze drying cycle

    Mostafa Nakach

    Mostafa Nakach, Head of Pharmaceutical Engineering Group, Sanofi-Aventis R&D

  • Two “old” products of the 60’s (called “A” and B”) performed with historical cycles exhibit aspects issues. The manufacturing of both products was intended to be carried out using a new and stated art freeze dryer. Due to the age of the products, very few process or physical chemistry data was available.
  • Therefore the manufacturing process was developed and optimized based on product knowledge, new freeze dryer knowledge, simulation and process modeling.
  • The objective of the presentation is to share how the methodology was applied and to outline the concrete benefit for both products

     

     

  • 12:20 Networking Lunch

    13:30 How to use water activity measurement and mathematical modelling to evaluate the stability of freeze-dried vaccines

    Erwan Bourles

    Erwan Bourles, Expert Scientist, Head Filling Drying Device, GSK

  • Definition of water activity
  • Examples of stability evaluation using Water activity measurement
  • Case Study on a vaccine formulation
  • 14:10 Long term storage stability of FD biologics: Effects of storage temperature

    Daryl Williams

    Daryl Williams, Director of Development, Chem. Eng. Discovery, Imperial College London

  • Challenge of drying high protein content materials
  • Stress thermal stability studies on model IgG formulation
  • Physicochemical and bioactivity analysis
  • Novel mechanical/ structural analytical methods
  • 14:50 Predicting stability of freeze dried pharmaceuticals

    Eric Munson

    Eric Munson, Professor, Pharmaceutical Sciences, University of Kentucky

  • Tools currently used to predict stability
  • Challenges associated and errors
  • Reducing errors in the predicted stability value
  • 15:30 Afternoon Tea

    16:00 Formulation considerations in the development of liposomes in a freeze-dried format

    Maryam Hussain

    Maryam Hussain, Research Assistant/ PhD Student, University Of Strathclyde

  • Considerations of the advantages and challenges to freeze-drying of liposomes and nanomedicines
  • Strategies to formulate these systems as stable freeze-dried products
  • Methods to rapidly screen and identify suitable freeze-dried formats
  • 16:40 Freeze-Dried Product appearance: Looking at the material and the immaterial

    Kevin Ward

    Kevin Ward, Director of R&D , BioPharma Technology

  • Macroscopic parameters: shape, uniformity, skin formation, shrinkage, defects in gross morphology and root causes
  • Micro-collapse: is it acceptable?
  • What effects might micro-collapse have on the product?
  • How can it be detected and predicted?
     
  • 17:20 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Sune Klint  Andersen

    Sune Klint Andersen, Principal Scientist Spray Drying , Janssen Pharmaceutica NV

    9:10 QbD in spray drying vs lyophilisation

    Sune Klint  Andersen

    Sune Klint Andersen, Principal Scientist Spray Drying , Janssen Pharmaceutica NV

  • Quality-by-Design strategies for drying processes
  • Typical sources of variation for lyophilization and spray drying processes
  • Timing/conditions for initiating QbD for drying processes
  • Applying PAT in drying process QbD
  • 9:50 PAT technologies for moisture and temperature monitoring for lyophilisation process

    Dikshitkumar Khamar

    Dikshitkumar Khamar, Senior Scientist, Genzyme Ireland Ltd

  • Development of non-invasive moisture monitoring methods and examples
  • Using head space moisture analyzer
  • Using NIR probe
  • Temperature monitoring systems for pilot scale as well as commercial scale freeze-dryers
  • Pros and cons of such measurements and feasibility of using these techniques at commercial scale and sterile fill operations
  • 10:30 Morning Coffee

    11:00 Lyophilization of a synthetic small molecule with antiviral activity for oral delivery (case study)

    Miguela Vieru

    Miguela Vieru, Research & Development, PDMS - Parenterals & Liquids, Janssen Pharmaceutica NV

  • Formulation development for an antiviral agent with low aqueous solubility
  • Lyophilization of a formulation containing cyclodextrin
  • Freeze dried product characterization
  • Spray drying as alternative technique to stabilize the drug product formulation
  • 11:40 Through Vial Impedance Spectroscopy – A new PAT for freeze-drying cycle development

    Geoff Smith

    Geoff Smith, Professor of Pharmaceutical Process Analytical Technology, DeMontford University

  • Description of the system and the measurement principles
  • Characterization of ice and the unfrozen fraction
  • Determination of single vial product temperature and drying rates
  • Applications for process parameter determination (Kv, Rp)
  • 12:20 Networking Lunch

    13:30 Novel approaches to reducing subjectivity and enhancing quantification in characterisation methods pre- and postlyophilisation

    Kevin Ward

    Kevin Ward, Director of R&D , BioPharma Technology

  • Applications of Thermal Analysis by Structural Characterisation (TASC) in freeze-drying microscopy (FDM)
  • Training operators to recognise the onset of collapse and reducing operator-to-operator variation
  • Quantification of the effect and impact of annealing at different temperatures
  • The use of quantitative Young’s Modulus (elasticity) measurements to provide a better understanding of:
  • The significance of temperature gradients across shelves in freezing and drying for different formulations
  • The robustness of different formulations to different lyophilisation conditions
  • 14:10 In silico approaches to aid rational design of freeze dried formulations

    Mire  Zloh

    Mire Zloh, Emeritus Professor of Medicinal Chemistry, University of Hertfordshire

  • Importance of intermolecular interactions between excipients and actives for their stability and/or solubility
  • In silico freeze drying of pharmaceutical formulations
  • Case studies: from a small molecule to protein therapeutics
  • Perspectives on applications of in silico tools in rational design of formulations
  • 14:50 Afternoon Tea

    15:20 PANEL - The future of novel technology for predicting cycles within the lyophilisation field

  • The current novel technologies which have been recently introduced into the market
  • The benefits of these technologies over existing technologies
  • Barriers to entry into implementation e.g. regulations, pricing etc
  • How can technologies be further developed?
  • Paul Matejtschuk

    Paul Matejtschuk, Principal Scientist, NIBSC

    Sune Klint  Andersen

    Sune Klint Andersen, Principal Scientist Spray Drying , Janssen Pharmaceutica NV

    Kevin Ward

    Kevin Ward, Director of R&D , BioPharma Technology

    Mostafa Nakach

    Mostafa Nakach, Head of Pharmaceutical Engineering Group, Sanofi-Aventis R&D

    16:00 Electrospin drying for pharmaceutical application

    16:40 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Daryl Williams

    Daryl Williams

    Director of Development, Chem. Eng. Discovery, Imperial College London
    Miguela Vieru

    Miguela Vieru

    Research & Development, PDMS - Parenterals & Liquids, Janssen Pharmaceutica NV
    Mostafa Nakach

    Mostafa Nakach

    Head of Pharmaceutical Engineering Group, Sanofi-Aventis R&D
    Paul Matejtschuk

    Paul Matejtschuk

    Principal Scientist, NIBSC
    Sune Klint  Andersen

    Sune Klint Andersen

    Principal Scientist Spray Drying , Janssen Pharmaceutica NV

    Daryl Williams

    Director of Development, Chem. Eng. Discovery, Imperial College London
    Daryl Williams

    Dikshitkumar Khamar

    Senior Scientist, Genzyme Ireland Ltd
    Dikshitkumar Khamar

    Eric Munson

    Professor, Pharmaceutical Sciences, University of Kentucky
    Eric Munson

    Erwan Bourles

    Expert Scientist, Head Filling Drying Device, GSK
    Erwan Bourles

    Geoff Smith

    Professor of Pharmaceutical Process Analytical Technology, DeMontford University
    Geoff Smith

    Georg Frinke

    Process Engineer, Bayer A G
    Georg  Frinke

    Kevin Ward

    Director of R&D , BioPharma Technology
    Kevin Ward

    Maryam Hussain

    Research Assistant/ PhD Student, University Of Strathclyde
    Maryam Hussain

    Miguela Vieru

    Research & Development, PDMS - Parenterals & Liquids, Janssen Pharmaceutica NV
    Miguela Vieru

    Mire Zloh

    Emeritus Professor of Medicinal Chemistry, University of Hertfordshire
    Mire  Zloh

    Mostafa Nakach

    Head of Pharmaceutical Engineering Group, Sanofi-Aventis R&D
    Mostafa Nakach

    Patrick Garidel

    Process Sciences Department, Head of Pharmaceutical Basic Development, Boehringer-Ingelheim
    Patrick  Garidel

    Paul Matejtschuk

    Principal Scientist, NIBSC
    Paul Matejtschuk

    Sune Klint Andersen

    Principal Scientist Spray Drying , Janssen Pharmaceutica NV
    Sune Klint  Andersen

    Sponsors and Exhibitors

    Supporters

    Workshops

    From Physical Properties to Lyophilised Product
    Workshop

    From Physical Properties to Lyophilised Product

    Holiday Inn Kensington Forum
    12th June 2018
    London, United Kingdom

    VENUE

    Holiday Inn Kensington Forum

    97 Cromwell Road , London, United Kingdom

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

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

    HOTEL BOOKING FORM

    [SPONSOR] - NEXTARO'S PRODUCT LINE

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    [SPEAKER INTERVIEW] - CHAIRMAN: Sune Klint Andersen - Janssen

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    [2018 ATTENDEE LIST] - PRELIMINARY

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    [2016 ATTENDEE LIST]

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    [2017 ATTENDEE LIST]

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    [PAST ATTENDEE BREAKDOWN] - INFOGRAPHIC OF LAST YEAR

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    [WORKSHOP A] - FULL DETAILS, OVERVIEW & BIO

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    [WORKSHOP B] - FULL DETAILS, OVERVIEW & BIO

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    [2017 PRESENTATION] - Pfizer

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    [DAY 1 | 13TH JUNE 2018] - FULL PROGRAMME

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    [DAY 2 | 14TH JUNE 2018] - FULL PROGRAMME

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    [2018 BROCHURE] - PHARMA FREEZE DRYING TECH

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    [LIST OF 2018 SPEAKERS] - THIS YEAR'S LINE-UP

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    [SPEAKER INTERVIEW] - Dikshitkumar Khamar, Senior Scientist, Genzyme Ireland

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    [SPEAKER INTERVIEW] - Paul Matejtschuk, Principle Scientist, NIBSC-MHRA

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    Sponsors and Exhibitors


    Nextaro

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

    nextaro® is the quality benchmark for reconstitution of lyophilized pharmaceutical components. With its key advantages being the patented screw system and the optimized handling through the use of two component plastic, nextaro provides the market's best stability, and is suitable for people with ailments or those who are in a hurry. The modular design makes nextaro® customizable to meet the individual requirements of each drug. Contact us today and top off your high quality application set with the device it deserves.

    Media Partners


    Inderscience Publishers

    Supporters
    http://www.inderscience.com

    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.


    Gate2Biotech

    Supporters
    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.


    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 online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


    Farmavita

    Supporters
    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.


    World Pharma News

    Supporters
    http://www.worldpharmanews.com/



    Pharma Marketing Magazine

    Supporters
    http://magazine.pharmamkt.net/



    Inderscience Publishers

    Supporters
    http://www.inderscience.com

    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.


    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.


    GBI

    Supporters
    http://www.gbihealth.com/

    GBI is an information, applications, and services company focused on the healthcare industry. Leveraging data from across the healthcare value chain, GBI creates web and mobile applications that enable individuals and organizations to make better decisions and communicate more effectively.


    Technology Networks

    Supporters
    http://go.technologynetworks.com/subscribe-to-newsletters

    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


    Biocompare

    Supporters
    http://www.biocompare.com

    Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


    pharmaphorum

    Supporters
    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    International Pharmaceutical Industry

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    http://www.ipimediaworld.com

    IPI gives you an insight into all areas of Biopharm, Medical, Pharmaceutical and Healthcare. IPI provides a proven supportive means of communication to the Pharmaceutical, Bio Pharmaceutical, Nutraceutical and Medical Devices industry, incorporating the latest in research and technology innovations, regulatory guidelines, marketing and communication strategies.

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    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. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

    HOTEL BOOKING FORM

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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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