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In Vitro Diagnostics

SAE Media Group 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.*

SAE Media Group'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

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

Conference agenda

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13:30

Registration & Coffee

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14:00

The upcoming IVDR – an 8 step implementation

Gert Bos

Gert Bos, Executive Director & Partner , Qserve Consultancy

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15:00

CASE part 1 – Impact analysis

Gert Bos

Gert Bos, Executive Director & Partner , Qserve Consultancy

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16:00

Afternoon Tea

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16:30

CASE part 2 – Portfolio analysis and preparation part 3

Gert Bos

Gert Bos, Executive Director & Partner , Qserve Consultancy

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17:00

CASE part 3 – presentation of plan to the Board

Gert Bos

Gert Bos, Executive Director & Partner , Qserve Consultancy

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17:30

Close of Workshop

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Sue Spencer

Sue Spencer, Global Service Line Director, UL International

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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

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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

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10:30

Morning Coffee

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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

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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

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12:20

Networking Lunch

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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
  •  

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    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

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    14:40

    Afternoon Tea

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    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
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    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
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    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

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    17:10

    Chairman’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Chris Dark

    Chris Dark, QARA Director, Arkray Inc

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    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

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    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?

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    10:30

    Morning Coffee

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    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
     

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    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

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    12:20

    Networking Lunch

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    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
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    14:00

    Identification, traceability of devices and UDI implementation

    Ulrike  Kreysa

    Ulrike Kreysa, Vice-President Healthcare , GS1

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    14:40

    Afternoon Tea

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    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

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    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

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    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

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    17:10

    Chairman’s Closing Remarks and Close of Day Two


    Medical Devices, EU Policy Manager
    MHRA
    Director of Office of In Vitro Diagnostics and Radiological Health
    Food and Drug Administration
    Principal Certification Manager
    Dekra
    Regulatory Affairs Manager
    Lifescan (J&J)
    QARA Director
    Arkray Inc
    IVD Manager
    TUV SUD
    Global Head - IVD
    BSI
    Project Manager Companion Diagnostics
    Tuv Rheinland
    Vice President and Head of Diagnostics
    Pfizer
    Director Quality and Regulatory Affairs
    Berlin Heart A G
    Certification Project Manager
    LNE/G-MED
    Manager II, Safety Risk Manager & Surveillance & Distribution Quality
    Ortho Clinical Diagnostics
    Principal Consultant
    Qarad Bvba
    Director
    ARQon Asia Regulatory & Quality Consultancy
    Technical Manager-IVD,
    LRQA
    Global Service Line Director
    UL International
    Vice-President Healthcare
    GS1

    Sponsors and Exhibitors

    Supporters

    Workshops

    A roadmap to implement EU-IVDR compliance program

    A roadmap to implement EU-IVDR compliance program

    Holiday Inn Kensington Forum
    13 June 2017
    London, United Kingdom

    A roadmap to implement EU-IVDR compliance program

    A roadmap to implement EU-IVDR compliance program

    Holiday Inn Kensington Forum
    13 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.

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    Technology Networks

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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.


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    FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!


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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.


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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, 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.

    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@saemediagroup.com

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