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Controlled Release

SAE Media Group is proud to announce the return of their 13th annual Controlled Release event to London in 2016! Controlled-release (CR) drug-delivery systems continue to play an important role in the treatment of diseases.

With an increase prevalence of cancer globally and advanced developments in controlled release technologies, controlled release remains the top priority for formulation scientists. Recent breakthroughs include the utilisation of nanotechnology and hydrogel polymers in controlled release mechanisms. In particular a long-acting insulin analogue shows promise for the treatment of diabetes, a unique approach which activates a micelle formation, facilitating transport of drug and significantly increasing absorption with a 10 to 50 fold increase in bioavailability.*

SAE Media Group’s 13th Controlled Release 2016 event will engage you in lively discussions with industry leaders to discover the latest innovations, as well as guiding you through the latest regulatory updates to ensure strict compliance. Through the 2-day meeting, you will learn about up and coming novel controlled release strategies to accelerate commercialisation.

*http://www.pharmtech.com/oral-absorption-enhancing-drug-delivery-technology


 

FEATURED SPEAKERS

Marion Westwood

Marion Westwood

Senior Pharmaceutical Assessor, MHRA
Mark Wilson

Mark Wilson

Director Platform Technology and Science , GlaxoSmithKline
Sune Andersen

Sune Andersen

Principal Scientist Drying Processes, Novo Nordisk A / S

Daniel Margetson

Director CMC, Diurnal
Daniel Margetson

Dario Carugo

Research Fellow, University of Oxford & University of Southhampton
Dario Carugo

Harpreet Sandhu

Senior Director, Kashiv Pharma
Harpreet  Sandhu

Howard Stevens

Professor, University Of Strathclyde
Howard Stevens

Kathryn Hill

Associate Principal Scientist, AstraZeneca
Kathryn Hill

Liam Good

Director, Tecrea Ltd
Liam Good

Marion Westwood

Senior Pharmaceutical Assessor, MHRA
Marion Westwood

Dr Marion Westwood, is a senior pharmaceutical assessor from the Medicines and Healthcare products Regulatory Agency (MHRA) licensing division. She is an assessor in the team responsible for oncology and rheumatology products.

Marion completed her PhD in drug delivery from biomaterials at Queens University, Belfast.
She has worked at the MHRA for more than 6 years and has a wide range of experience in regulatory processes for almost all types of submissions, including generic applications and new active substances.
Marion has a particular interest in drug device combination products and is a member of the internal drug-device combination working group at the MHRA. She is also involved in the MHRA’s paediatric formulation working group.
 

Mark Wilson

Director Platform Technology and Science , GlaxoSmithKline
Mark Wilson

Mohammad Absar

Pharmacologist, FDA
Mohammad  Absar

Rene Holm

Senior Director, H Lundbeck A/S
Rene Holm

Saif Shubber

Formualtion Scientist, MedImmune Inc.
Saif Shubber

Samir Haddouchi

Managing Director, SPS Pharma Services
Samir Haddouchi

Stuart Robinson

Head of Business Development, Critical Pharmaceuticals Limited
Stuart  Robinson

Sune Andersen

Principal Scientist Drying Processes, Novo Nordisk A / S
Sune Andersen

sponsors

Conference agenda

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8:30

Registration & Coffee

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9:00

Introduction from Workshop Leaders

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9:10

Introduction to QbD - General principles & focus on Product understanding/ Analytical testing elements

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10:00

Selection of DoE Approach Answering QTPP Requirements - MR formulation case study

Jerome Mantanus

Jerome Mantanus, Senior Scientist QbD/PAT Drug Product Formulation, UCB Pharma

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10:15

Taking Advantage of Design Space to Identify Robust Formulation

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10:30

Morning Coffee

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11:00

PAT to Gain Formulation & Process Understanding During Development and Scale Up

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11:15

PAT for Real Time Process Monitoring and End-point Detection

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11:30

Q&A

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12:00

End of Workshop

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13:00

Registration & Coffee

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13:30

Introduction from Workshop Leaders

Rene Holm

Rene Holm, Senior Director, H Lundbeck A/S

Clive Wilson

Clive Wilson, Professor of Pharmaceutics, University of Strathclyde

Ijeoma Uchegbu

Ijeoma Uchegbu, Scientific Secretary CRS, Chair in Pharmaceutical Nanoscience, University Of London

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14:00

What Does the Industry Need Now?

Rene Holm

Rene Holm, Senior Director, H Lundbeck A/S

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15:00

Afternoon Tea

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15:30

The Biological: What Can We and Can’t We Do in the Gut?

Clive Wilson

Clive Wilson, Professor of Pharmaceutics, University of Strathclyde

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16:30

The chemical: Will Nanotechnology Solvate all our Problems?

Ijeoma Uchegbu

Ijeoma Uchegbu, Scientific Secretary CRS, Chair in Pharmaceutical Nanoscience, University Of London

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17:00

Q&A

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17:30

End of Workshop

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Howard Stevens

Howard Stevens, Professor, University Of Strathclyde

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9:10

MHRA: Supporting innovation in controlled release and combination products

Marion Westwood, Senior Pharmaceutical Assessor, MHRA

  • Discuss the latest innovations surrounding controlled release
  • Gain key regulatory updates from leading competent authorities talking specifically on grey areas such as the regulatory environment surrounding combination products
  • Case study on work with OxSonics.
     
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    9:50

    Controlling peptide stability to unlock their therapeutic potential

  • Peptides as pharmaceutical drugs
  • Challenges to their formulation and delivery
  • Overcoming the challenges; formulation development and drug delivery
  • Future directions and conclusions
     
  • Saif Shubber

    Saif Shubber, Formualtion Scientist, MedImmune Inc.

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    10:30

    Morning Coffee

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    11:00

    Application of Quality-by-Design during spray drying scale-up

    Sune Andersen

    Sune Andersen, Principal Scientist Drying Processes, Novo Nordisk A / S

  • Examining the use of spray drying in controlled release
  • Linking lab-scale QbD with production scale QbD
  • Scale-up impact on solid dosage forms
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    11:40

    How are combination products altering the drug delivery landscape?

    Howard Stevens

    Howard Stevens, Professor, University Of Strathclyde

  • Current issues with the combination of drugs with different release mechanisms
  • The regulatory environment surrounding combination products with different controlled release mechanisms
  • Who can support you with regulatory compliance?
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    12:20

    Networking Lunch

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    13:30

    Telebriefing: Regulatory perspective on innovative systems for controlled release

    Mohammad  Absar

    Mohammad Absar, Pharmacologist, FDA

    · An overview of current innovative controlled release systems in the US market
    · Scientific and regulatory challenges in developing generic controlled release systems
    · FDA/OGD’s ongoing research programme
     

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    14:10

    The importance of controlled release in nanomedicine design

    Kathryn Hill

    Kathryn Hill, Associate Principal Scientist, AstraZeneca

  •  Predicting modelling for nanomedicine design
  • Optimising drug release from a nanomedicine to improve therapeutic index
  • Comparison of different nanomedicines in improving therapeutic index
  • Case studies and data sharing
     
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    14:40

    Nanocin™: a novel polymer-based platform for nanomedicine

    Liam Good

    Liam Good, Director, Tecrea Ltd

    • Nanocin™ forms nanoparticles on interaction with nucleic acids, proteins, peptides and small molecules
    • The polymer has a low toxicity profile and a long history of safe use
    • Nanocin™:drug particles and examples of cell entry and functional effects will be presented
     

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    15:50

    Chairman’s Closing Remarks and Close of Day One

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    16:15

    Afternoon Tea

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Mark Wilson

    Mark Wilson, Director Platform Technology and Science , GlaxoSmithKline

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    9:10

    An industrial perspective on novel oral dose controlled release technologies

    Mark Wilson

    Mark Wilson, Director Platform Technology and Science , GlaxoSmithKline

  • GSK’s activities to develop new platform drug delivery technologies
  • Approaches to collaboration and partnering with external organisations
  • The application and implementation of new technologies within GSK
     

             

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    9:50

    Microfluidics and drug delivery systems for controlled release: production, characterisation and industrial translation

    Dario Carugo

    Dario Carugo, Research Fellow, University of Oxford & University of Southhampton

  • Production of nanoscale and microscale drug delivery vehicles using microfluidic technology
  • Development of acoustofluidic platforms for ultrasound-mediated intracellular delivery of therapeutic compounds
  • Biomimetic microfluidic architectures to investigate drug release processes within physiologically-relevant microenvironments
  • Industrial translation of microfluidic technology: Challenges and future perspectives
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    10:30

    Morning Coffee

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    11:00

    Dissolution testing: A key tool for a better product design

    Samir Haddouchi

    Samir Haddouchi, Managing Director, SPS Pharma Services

  • Principles of dissolution
  • How does dissolution relate to biopharmaceutical classification system (BCS) and  in vitro/in vivo correlation (IVIVC)
  • API characterisation and dissolution
  • Case studies
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    11:40

    How to formulate poorly soluble drugs

    Rene Holm

    Rene Holm, Senior Director, H Lundbeck A/S

  • Available pharmaceutical technologies for formulating low sol compounds
  • Technical and biopharmaceutical considerations of the technologies
  • Future trends in the formulation of low soluble compounds
     
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    12:20

    Networking Lunch

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    13:50

    CriticalMix platform technology: A novel platform technology for sustained delivery of small and large API’s

    Stuart  Robinson

    Stuart Robinson, Head of Business Development, Critical Pharmaceuticals Limited

  •  Overview of who Critcal Pharmaceuticals are
  • Issues with current technologies surrounding microparticles for API’s of all sizes
  • Overview and advantages of the CriticalMix process
  • Case studies
     
     
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    14:30

    Selection and development of controlled release technology suitable for adult and paediatric dosing

    Harpreet  Sandhu

    Harpreet Sandhu , Senior Director, Kashiv Pharma

  • Multiparticulate controlled release formulations are well known for providing superior controlled release compare to the monolithic systems due to lower food effect and uniform gastric emptying
  • The advantages of multiparticulate system was further extended to maximise the dosing flexibility during development for adult and paediatric dosing
  • Product development including the selection of technology, release mechanism, and development of IVIVR/IVIVC will be discussed 

     

     

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    15:10

    Afternoon Tea

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    15:40

    Optimising drug delivery systems to mimic the human circadian rhythm

    Daniel Margetson

    Daniel Margetson, Director CMC, Diurnal

  • The influence of circadian rhythm on human physiological systems and disease state
  • Optimising drug release to reflect the natural human circadian cycle
  • Controlled release therapies for circadian therapeutic areas of interest: Chronocort®- a case study
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    16:20

    Chairman’s Closing Remarks and Close of Day Two

    Mark Wilson

    Mark Wilson, Director Platform Technology and Science , GlaxoSmithKline


    Director CMC
    Diurnal
    Research Fellow
    University of Oxford & University of Southhampton
    Senior Director
    Kashiv Pharma
    Professor
    University Of Strathclyde
    Associate Principal Scientist
    AstraZeneca
    Director
    Tecrea Ltd
    Senior Pharmaceutical Assessor
    MHRA
    Director Platform Technology and Science
    GlaxoSmithKline
    Pharmacologist
    FDA
    Senior Director
    H Lundbeck A/S
    Formualtion Scientist
    MedImmune Inc.
    Managing Director
    SPS Pharma Services
    Head of Business Development
    Critical Pharmaceuticals Limited
    Principal Scientist Drying Processes
    Novo Nordisk A / S

    Sponsors and Exhibitors

    Supporters

    Workshops

    QbD/PAT Driven Controlled Release Design and Development

    QbD/PAT Driven Controlled Release Design and Development

    Holiday Inn Regents Park
    20 April 2016
    London, United Kingdom

    Exploring Controlled Release Drug Delivery Methods

    Exploring Controlled Release Drug Delivery Methods

    Holiday Inn Regents Park
    20 April 2016
    London, United Kingdom

    Preliminary list of attendees for Controlled Release

    Download

    Controlled Release Interview with the US FDA

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    Controlled Release Interview with the MHRA

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    Controlled Release Interview with Kashiv Pharma

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    Controlled Release Interview with Merck

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    Sponsors and Exhibitors


    Sotax

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

    SOTAX is a global leader in providing innovative solutions for pharmaceutical testing. The company offers high-quality dissolution testing systems, physical tablet testing instruments, automated sample preparation workstations for composite assay and content uniformity testing, as well as associated technical and application services.

    Media Partners


    International Journal of Biotechnology

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    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.


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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 the latest drug discovery and development technologies, products and techniques with product reviews, videos, application notes and news articles. Become a member for free today.


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    In recent years, frontiers of research in engineering, science and technology have been driven by developments in nanomaterials, encompassing a diverse range of disciplines such as materials science, biomedical engineering, nanomedicine and biology, manufacturing technology, biotechnology, nanotechnology, and nanoelectronics. IJNBM provides an interdisciplinary vehicle covering these fields. Advanced materials inspired by biological systems and processes are likely to influence the development of novel technologies for a wide variety of applications from vaccines to artificial tissues and organs to quantum computers.


    American Pharmaceutical Review

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    Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy


    British Pharmacological Society

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    The British Pharmacological Society (BPS) is the primary UK learned society concerned with research into drugs and the way they work. Our members work in academia, industry, regulatory agencies and the health services, and many are medically qualified. The Society covers the whole spectrum of pharmacology, including laboratory, clinical, and toxicological aspects. Clinical pharmacology is the medical speciality dedicated to promoting safe and effective use of medicines for patient benefit. Clinical pharmacologists work as consultants in the NHS and many hold prominent positions in UK Universities.


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    IJCBDD, an International Society of Intelligent Biological Medicine official journal, bridges the gap between two very important, complementary disciplines, computational biology and drug design. Through advances in high-throughput genome sequencing and digital imaging technologies, biocomputing, drug design and medical research have unfolded new, predictive sciences such as genomics, proteomics, lipidomics, metabolomics, cytomics and pharmaconomics. These promote new computational, statistical and biomedical approaches to drug design/development, besides unleashing the potential of significantly more accurate, effective personalised diagnosis, therapeutics and patient care.


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    Nanoparticles are becoming key components in a wide range of applications. Research encompasses numerous disciplines, e.g. nanotechnology, molecular engineering, medicine, pharmaceutical drug manufacture, biology, chemistry, physics, optical components, polymer science, mechanical engineering, toxicology, cosmetics, energy, food technology and environmental and health sciences. IJNP highlights the chemical, physical and biological phenomena/processes associated with nanoparticles and nanostructures ranging from molecular size to 100nm which exhibit improved properties or have novel applications due to their size. Submicron nanoparticles are included in special cases.


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    antibodies-online.com facilitates researchers to find the appropriate antibodies for their respective research project. As an independent and multi-vendor marketplace for research antibodies and thanks to the cooperation with more than 130 different manufacturers, a large selection of Antibodies (over 700,000), ELISA Kits (over 130,000), Secondary Antibodies (17,000), Proteins (130,000), Peptides and Isotype Controls is available. By supporting the Independent Validation Initiative and the Resource Identification Initiative, antibodies-online.com also addresses the important topics of transparent product quality and scientific reproducibility. In addition scientists receive news and detailed information about the individual antibodies from databases such as the PubMed and others.


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    Holiday Inn Regents Park

    Carburton Street
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    Holiday Inn Regents Park

    Choose the well-connected Holiday Inn London-Regent's Park hotel, with a superb central London location and speedy transport links. Holiday Inn London-Regent's Park is in a leafy and cosmopolitan area of central London, a 10-minute walk from bustling Oxford Street. Leave your car in our NCP managed underground car park, and explore London by Tube. Great Portland Street Tube station is 25 metres from the hotel, from where you can reach the City and Canary Wharf in 30 minutes, and London Heathrow Airport in 45 minutes.

    Wireless Internet is available throughout the hotel, and you can invite up to 300 people to events at the Academy Conference Centre, with an IT technician and break-out zones. Holiday Inn London-Regent's Park is a 10-minute walk from Santander's offices and businesses in the BT Tower. Stroll 5 minutes to Regent's Park, where you'll find London Zoo and pretty Primrose Hill. We're a 10-minute walk from Bond Street boutiques and 20 minutes from Buckingham Palace and cruises on the River Thames.

    Ask our Concierge to plan your day out and book West End theatre tickets. Room Service is available 24 hours at Holiday Inn London-Regent's Park, or dine in the vibrant Junction Restaurant. Our Junction Bar has a menu of light bites, and a hot breakfast buffet is served daily.

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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)

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    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, SAE Media 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.

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