8th Annual Clinical Evaluations and Investigations for Medical Devices

www.informa-ls.com/clinicalstudy 

8th Annual 

Clinical Evaluations 

and Investigations 

Medical device recalls around 

the world have increased 

significantly in recent years: 

Don’t miss this crucial 

opportunity to discover 

how your clinical 

studies can help 

prevent 

product 

recall 

for Medical Devices 

Practical industry case studies, Competent Authority expectations and Notified Body insight for 

compliant, cost-effective clinical studies and the impact of the revision of the Medical Devices Directive 

Our expert speaker panel includes: 

• Rob Higgins, Regulatory 

Section Head, MHRA, UK 

• Paul Scannell, Pre-Market 

24-25 April 2013 | Radisson Royal Blu Hotel | Dublin | Ireland 

Competent 

Authorities 

Evaluation Officer, Irish Medicines Board, Ireland 

• Peter Bunyitai, Head of Department, Department 

of Medical Devices, Office of Health 

Authorisation and Administrative Procedures, 

Hungary 

• John O’Dwyer, European 

Manager, NSAI, Ireland Notified 

• Gert Bos, Head of Regulatory Bodies 

and Clinical Affairs, BSI, UK 

• Bassil Akra, IMC - Clinical Affairs, TÜV SÜD 

Product Service GmbH, Germany 

• Philippe Auclair, Senior Director, Abbott Quality 

& Regulatory EMEA, Belgium 

• David Appleby, Director, Biostatistics and Clinical 

Data Management, Smith & Nephew, USA 

• Ryan Magee, Global Post Market Compliance 

Manager, Senior, Boston Scientific, USA 

• Birte Petersen Jakobsen, Director, Medical 

Affairs, Global R&D, Coloplast A/S, Denmark 

• Lynne Kelley, WW Vice President Medical Affairs, 

Becton Dickinson, USA 

• Victoria Cavendish, Senior Clinical Project 

Manager, Reckitt Benckiser Healthcare UK 

Ltd, UK 

• Ian Quirk, Worldwide Director of Clinical and 

Regulatory Affairs, Ranier Technology Ltd., UK 

• Ruud Nonnekens, Manager Clinical Affairs, 

Volcano Europe, Belgium 

• Sven Knapinski, Head of Premarketing Clinical 

Trials, Institut Straumann AG, Switzerland 

• Greg LeBlanc, Manager, Regulatory Affairs and 

Quality Systems, Cook (Canada) Inc., Canada 

• Torsten Kayser, PhD., Senior Fellow Clinical 

Research, Boston Scientific, Belgium 

• Pat Baird, Systems Engineering Specialist, Baxter 

International, USA 

• Sarah Sorrel, President, MedPass 

International, France 

• Martine Callaert, Clinical Trial Project Manager 

EMEA, Terumo BCT Europe N.V., Belgium 

• Erik Vollebregt, Partner, Axon Lawyers, The 

Netherlands 

• Alex Denoon, Partner, Lawford Davies 

Denoon, UK 

What makes this event unbeatable 

3 Hear from the Competent Authorities and 3 top Notified Body speakers on key 

issues including roles and expectations related to the revision of the Medical 

Devices Directive (MDD) 

3 13 industry case studies from leading industry experts on key topics including clinical 

investigations in emerging market regions and post-market clinical follow-up 

3 Interactive round table discussion on successfully outsourcing clinical studies 

3 9+ hours of networking with experts in the field 

Don’t miss out on these exciting topics for 2013… 

3 Essential regulatory update including how the revision of the Data Protection 

Directive will impact clinical investigations and data 

3 Examining whether the EU Clinical Trials Directive could have a feedback 

impact on the new medical device regulations 

3 Real life case studies on designing and conducting a clinical trial 

3 Practically meeting requirements for MEDDEV 2.7/3 on serious adverse events 

reporting, MEDDEV 2.12/2 rev 2 on post-market clinical follow-up and 

MEDDEV 2.7/1 rev 3 clinical evaluation guidance document 

Tuesday 23 April 2013: Pre-Conference Workshop X 

Practically Obtaining Clinical Evidence for Successful Market Access and 

Reimbursement 

Led by: Lucio Fumi, MD. CEO, Wyfold Medical Consultancy, UK 

Dr Paul C. Knox, Reader in Vision Science, University of Liverpool and Member of NICE’s Medical 

Technologies Advisory Committee, UK 

Lynne Kelley, WW Vice President Medical Affairs, Becton Dickinson, USA 

Öznur Seyhun, Reimbursement Manager, Medtronic, Inc., Turkey 

Isabel Henkel, Head of Market Access and Public Policy Europe, Grifols Deutschland GmbH, Germany 

Wednesday 24 April 2013: Evening Seminar S 

Regulatory Evening Surgery: Harmonisation and Successfully Working with 

Medical Devices Manufacturers 

Led by: Rob Higgins, Regulatory Section Head, MHRA, UK 

Gert Bos, Head of Regulatory and Clinical Affairs, BSI, UK 

Bassil Akra, IMC - Clinical Affairs, TUEV SUED Product Service GmbH, Germany 

John O’Dwyer, European Manager, NSAI, Ireland 

Friday 26 April 2013: Post-Conference Workshop Y 

Practical Advice on Successful Use of Software, Electronic Data Capture 

and Apps for Clinical Evaluations and Investigations 

Led by: Erik Vollebregt, Partner, Axon Lawyers, The Netherlands 

Alex Denoon, Partner, Lawford Davies Denoon, UK 

Mathias Klümper, Partner, Lützeler Klümper Wachenhausen, Germany 

Event Sponsors: 

To Register Please Tel: +44 (0) 20 7017 7481 Web: www.informa-ls.com/clinicalstudy 

Fax: +44 (0) 20 7017 7823 Email: registrations@informa-ls.com Please quote CQ7104 

Media Partner:

Pre-Conference Workshop X Tuesday 23 April 2013 

Practically Obtaining Clinical Evidence for Successful Market Access and Reimbursement 

Registration is at 09:00 for a 09:30 start. The workshop will finish no later than 16:00.Workshop documents, refreshments and a networking lunch will be provided. 

In this interactive workshop, delegates will gain valuable information on precisely how to optimise clinical 

data analysis and quality to achieve approval and reimbursement. Delegates will also hear practical advice 

on overcoming the challenge of differing requirements for reimbursement across Europe and the US. 

Optimising clinical data generation, analysis and quality to achieve approval and reimbursement 

• Understanding the importance of considering data you would need for a successful cost-effectiveness 

argument early on in the clinical trial process 

• Ensuring that information of the right level and quality is delivered to the decision makers 

• Practical advice on how to assemble this data for a successful cost-effectiveness argument 

Optimising clinical data generation, analysis and quality to achieve approval and reimbursement 

for the MEA region 

• Significance of creating a trial model for a successful cost-effectiveness outcome 

• To reinforce the influence stage of decision makers to enchance the process of how the results are 

perceived 

Conference Day One: Wednesday 24 April 2013 

08.30 Conference registration 

09.00 Opening remarks from the Chair 

David Appleby, Director, Biostatistics and Clinical Data Management, Smith & Nephew, 

USA 

Critical Regulatory Updates: Europe 

09.10 Competent Authority perspective: Practical advice on successfully adapting to changing 

regulatory requirements 

• Examining how the regulations have changed over the past two years and what further 

changes are expected on the horizon 

• Reviewing how the revision of the MDD will impact clinical requirements and how this 

will affect industry 

• Understanding what Competent Authorities consider as optimal clinical trial design 

COMPETENT 

AUTHORITY 

• Evaluating what Competent Authorities are looking for with clinical evaluation through 

existing data 

Rob Higgins, Regulatory Section Head, MHRA, UK 

09.45 Assessing the revision of the Data Protection Directive and how this will impact clinical 

investigations and data 

• Understanding the key ways in which the revision of the Data Protection Directive will 

impact clinical investigations and clinical data 

• Clarifying whether the revision of the Data Protection Directive will help to harmonise 

clinical trial requirements from Competent Authorities throughout Europe 

• Practical advice on how industry can prepare for the revision of the Data Protection 

Directive 

• Examining the key differences between EU and US data protection requirements 

Alex Denoon, Partner, Lawford Davies Denoon, UK 

10.20 Practically conducting a medical device clinical trial in Hungary 

• Introduction of an up-to-date regulation 

• Elements of acknowledgement 

• Experiences and future plans 

COMPETENT 

AUTHORITY 

Peter Bunyitai, Head of Department, Department of Medical Devices, Office of Health 

Authorisation and Administrative Procedures, Hungary 

10.55 Networking and morning coffee 

Revision of the MDD: Impact on Clinical Evaluations and Investigations 

11.25 Examining the impact of the revision of the Medical Devices Directive (MDD) on clinical 

evaluations and investigations 

• Evaluating the key expected changes that will affect clinical evaluations and investigations 

• Clarifying the idea of centralised application processing for multi-centre clinical 

investigations: What will the requirements be and how will this impact industry 

• Exploring the current status of Eudamed, the changes the revision of the MDD will bring 

and how this will impact clinical data for industry 

• Reviewing new timelines for approval of starting clinical studies 

Philippe Auclair, Senior Director, Abbott Quality & Regulatory EMEA, Belgium 

12.00 Understanding how the EU Clinical Trials Directive could have a feedback impact on the 

revision of the MDD 

• Assessing the key points where the revision of the EU Clinical Trials Directive might have 

a feedback impact on the new medical device regulations 

• Reviewing where in the MDD the pharma system is referred to, including use of database 

• Examining how Competent Authorities can tend to use at least some pharma requirements 

as medical device guidelines can be less clear 

• Understanding whether there will be a possibility to communicate between the medical 

device and pharma systems 

Erik Vollebregt, Partner, Axon Lawyers, The Netherlands 

12.35 Notified Body perspective: Practically meeting requirements for clinical evaluations 

• Outlining the key requirements and expectations of Notified Bodies when reviewing clinical 

data 

• Understanding how the role of the Notified Body will change in reviewing clinical trials 

NOTIFIED 

BODY 

data with the revision of the MDD and how this will impact industry 

• Practical advice on complying with requirements for MEDDEV 2.7/1 rev 3 

• Examining whether Notified Bodies have become increasingly strict when evaluating third 

party clinical data used by the manufacturer 

Please see website www.informa-ls.com/clinicalstudy for full details 

Setting realistic expectations for the timelines from study concept to regulatory approval in China 

and other emerging markets 

Understanding evidence from the decision makers’ perspective 

• Different decision makers means different evidence 

• The hierarchy of clinical evidence that informs decisions 

Lucio Fumi, MD. CEO, Wyfold Medical Consultancy, UK 

Dr Paul C. Knox, Reader in Vision Science, University of Liverpool and Member of NICE’s Medical 

Technologies Advisory Committee, UK 


Isabel Henkel, Head of Market Access and Public Policy Europe, Grifols Deutschland GmbH, 

Germany 

Öznur Seyhun, Reimbursement Manager, Medtronic, Inc., Turkey 

• Reviewing Notified Body feedback on clinical data: What are common pitfalls and how 

can industry overcome these 


13.10 Networking lunch 

14.10 TÜV SÜD’s perspective: Clinical evaluation requirements 

• Evaluating key requirements and expectations of TÜV SÜD when reviewing clinical data 

• Examining how the Notified Body role will change in reviewing clinical trials data with 

the revision of the MDD and how this will impact industry 

• Practically complying with requirements for MEDDEV 2.7/1 rev 3 

• Understanding whether Notified Bodies have become increasingly strict when evaluating 

third party clinical data 

• What are common pitfalls for clinical data and how can industry overcome these 

Bassil Akra, IMC - Clinical Affairs, TÜV SÜD Product Service GmbH, Germany 

14.45 Notified Body perspective: Successfully meeting expectations for clinical investigations 

• Reviewing the current status of ISO 14155:2011 and whether there are any further changes 

expected associated with the revision of the MDD 

• Practically meeting ISO 14155:2011 in terms of setting up processes and writing reports 

• Integrating and working simultaneously with ISO 14155, MEDDEV 2.7/1 rev 3 and 

MEDDEV 2.12/2 rev 2 

• Assessing how the role of Notified Bodies will change and how this will affect audit 

activities 


15.20 Spotlight session 

Raise your corporate profile by sponsoring or exhibiting at Informa Life Sciences’ 8th Annual 

Clinical Evaluations and Investigations for Medical Devices. For details on speaking in this 

session or other sponsorship opportunities at this conference, please contact 

Linda Cole, Tel: +44 (0) 20 7017 6631, Email: linda.cole@informa.com 

15.55 Networking and afternoon tea 

16.25 INTERACTIVE ROUND TABLE DISCUSSION: Successfully outsourcing clinical 

studies 

• Evaluating the pros and cons of outsourcing compared to conducting clinical studies in 

house 

• Strategically deciding what to outsource 

• Choosing the most appropriate Clinical Research Organisation (CRO) to suit your 

company. 

• Will the revision of the MDD will change clinical contracting practices 

Led by: Victoria Cavendish, Senior Clinical Project Manager, Reckitt Benckiser Healthcare 

UK Ltd, UK 

Case Studies: Clinical Evaluation 

17.00 Practically meeting the MEDDEV 2.7/1 rev 3 clinical evaluation guidance document 

• Key challenges in meeting MEDDEV 2.7/1 rev 3 

• What are the Notified Bodies looking for (differences between Class I/II/III) 

• Practical examples on gathering, evaluating and using information 

– Where the information came from 

– How to decide which information to include 

– How to draw comparisons and parallels from the information 

• Successfully estimating when and how often the clinical evaluation report should be 

updated in order to remain compliant 

Birte Petersen Jakobsen, Director, Medical Affairs, Global R&D, Coloplast A/S, Denmark 

Statistical Analysis 

17.35 Understanding how effective statistical analysis can be used to optimise scientific 

credibility of your clinical data 

• Exploring the optimal statistical techniques to assess the clinical data you obtain 

• Overcoming the challenge of small clinical trials with limited data and practical advice on 

which statistical techniques to use 

• Reviewing which statistical techniques are available and which are most appropriate to use 

• Assessing the key challenges associated with statistical analysis and how these can be 

overcome 

David Appleby, Director, Biostatistics and Clinical Data Management, Smith & Nephew, 

USA 

18.10 End of conference day one 

PROMOTIONAL OPPORTUNITIES 

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, 

you will be able to: 

• Meet new clients with an exhibition stand in the main networking area • Raise your corporate profile and shape your corporate image with logo placement 

• Launch new products and ensure market presence with a speaking slot • Develop new client relationships and affirm existing ones with your presence at the event 

We have a wide range of tailored sponsorship solutions, to find out more please contact: 

Linda Cole, Business Development Manager Email: linda.cole@informa.com Tel: + 44 (0) 20 7017 6631 


Fax: +44 (0) 20 7017 7823 Email: registrations@informa-ls.com Please quote CQ7104 

NOTIFIED 

BODY 

NOTIFIED 

BODY 

INTERACTIVE 

SESSION

08.30 Morning coffee 

Evening Seminar S Wednesday 24 April 2013 

Regulatory Evening Surgery: Harmonisation and Successfully Working with Medical Devices Manufacturers 

Registration is at 18:00 for an 18:15 start. The seminar will finish no later than 20:30. Seminar documents and an evening networking dinner will be provided. 

In this interactive seminar, delegates will have the opportunity to network with key Competent Authorities 

and Notified Bodies and take part in interactive Q&A sessions. Expectations and requirements for clinical 

evaluations and investigations for medical devices from both Competent Authorities and Notified Bodies 

across Europe will be analysed. 

Assessing the impact of the revision of the MDD on harmonisation 

• Understanding how the revision of the MDD will impact harmonisation across Europe 

• Examining how increased cooperation between authorities will be required including joint inspections 

and cooperation in post-market surveillance and vigilance 

Conference Day Two: Thursday 25 April 2013 

09.00 Opening remarks from the Chair 


Pre-Market Clinical Requirements 

09.10 Pre-market requirements: European considerations for new medical device start-ups 

• Assessing regulations and their impact on innovation and market access 

• A theoretical and empirical examination of a medical device start-up’s regulatory 

awareness 

• Reviewing the key areas of both the current and proposed pre-market regulatory 

COMPETENT 

AUTHORITY 

requirements; what, and when, should they be considered by medical device start-ups 

• Engaging with a Competent Authority – an Irish perspective 

Paul Scannell, Pre-Market Evaluation Officer, Irish Medicines Board, Ireland 

09.45 Practically meeting the MEDDEV 2.7/3 on serious adverse events (SAE) reporting for 

pre-market clinical investigations 

• Successfully complying with the current requirements for SAE reporting 

• Examining whether there will be any changes to SAE reporting with the revision of the 

MDD and how this will impact industry 

• Practical advice on successfully using the SAE reporting listing and form 

• Understanding the format you need to use for SAE reporting and how this varies in 

different countries 

• Evaluating whether there are increasing requirements for more information from 

Competent Authorities for SAE reporting 

Ryan Magee, Global Post Market Compliance Manager, Senior, Boston Scientific, USA 

10.20 Real life industry case study: Successfully conducting a pre-market clinical study and 

impact of the revision of the MDD 

• Examining how pre-market clinical studies will be affected by the revision of the MDD 

and how industry should be prepared 

• Understanding how to meet Competent Authority expectations when submitting a protocol 

and filling out forms 

• Clarifying exactly when to notify a Competent Authority if carrying out a clinical study 

• Overcoming the main challenges in conducting a pre-market clinical study 

Sarah Sorrel, President, MedPass International, France 

10.55 Networking and morning coffee 

Practically Designing and Conducting a Medical Device Clinical Trial 

11.25 Designing and conducting a clinical trial – Some practical considerations 

• Practical advice on the following key points: 

– Defining the goals of the study 

– Statistical considerations: Assessing how many patients should be involved 

– Deciding how many and which centers to use 

– How to decide which country to carry out your clinical trial and understanding which 

authorities will be involved 

– Setting up of and conducting the study (e.g. outsourcing) 

– Study compliance (e.g. processes respected, selecting the correct patients, ensuring 

case report forms are filled out timely) 

• Understanding the importance of remaining compliant with ISO 14155 throughout the process 

Ruud Nonnekens, Manager Clinical Affairs, Volcano Europe, Belgium 

12.00 SME perspective on clinical studies – practical examples 

• Outcomes selection for optimal trail performance 

• Avoiding ‘digit preference’ in endpoint selection 

• Managing recruitment 

• Navigating ethical committee/Competent Authority approvals 

• Fiscal compliance in centre contracts 

Ian Quirk, Worldwide Director of Clinical and Regulatory Affairs, Ranier Technology Ltd., UK 

12.35 Case study on a running pre market multi-center study in the US and Europe 

Practical advice on the following key points: 

• How to decide which country to carry out your clinical trial 

• Understanding which authorities will be involved 

• Alignment of different standards - ISO 14155 and FDA-GCP 

• eDC - balancing advantages and disadvantages 

Sven Knapinski, Head of Premarketing Clinical Trials, Institut Straumann AG, Switzerland 


Clarifying the latest developments in Competent Authority and Notified Body harmonisation 

• Examining discrepancies in Competent Authority expectations in regards to clinical evaluations and 

investigations across Europe 

• Evaluating variability in requests from Notified Bodies across Europe 

• Reviewing differing interpretations of ISO 14155 

**OPEN Q&A SESSION** 

Rob Higgins, Regulatory Section Head, MHRA, UK 


Bassil Akra, IMC - Clinical Affairs, TÜV SÜD Product Service GmbH, Germany 


14.10 Improving clinical trials by utilising Failure Modes and Effect Analysis 

Clinical studies are complex undertakings, involving significant time and effort by their 

sponsors. This presentation will discuss how to use traditional risk management tools in novel 

ways to improve the likelihood of study success. This presentation will cover: 

• The business need to improve study quality 

• Potential failure modes of a study 

• A case study using FMEA to identify areas for improvement 

Pat Baird, Systems Engineering Specialist, Baxter International, USA 

International Focus 

14.45 Practically meeting FDA requirements for clinical evaluations and investigations 

• Outlining key FDA requirements and how these compare to the EU 

• Understanding the importance of being careful and having data in the correct format when 

carrying your clinical study from the EU to the US 

• Exploring the FDA’s emphasis on increased data collection earlier on in the pre-market stage 

• Overcoming the key challenges experienced when carrying out clinical evaluations and 

investigations in the US 


15.20 Understanding the work of the Global Harmonisation Task Force (GHTF) Study Group 5 

(SG5): Documents on clinical evaluations and investigations and the evolution into the 

International Medical Device Regulators’ Forum (IMDRF) 

• Outlining the work of and perspectives from GHTF SG5 in the areas of clinical evaluations 

and investigations 

• Understanding the formation of the IMDRF and changes in how the clinical angle is 

approached 

• Examining whether there have been any changes to post-market clinical guidance since 

development of the IMDRF 

• Exploring perspectives on which kind of adverse events need to be reported 

Greg LeBlanc, Manager, Regulatory Affairs and Quality Systems, Cook (Canada) Inc., Canada 

15.55 Networking and afternoon tea 

16.25 Practically conducting clinical investigations in emerging market regions 

• Key emerging market regions for medical devices including China, India and Latin 

America 

• Experiences with the regulatory processes and strategies to assure compliance when 

conducting clinical trials in these regions 

• Key cultural differences in these regions and comparing to the EU 

• Understanding how genetic differences in populations can impact clinical trials and what 

the regulators expect when running global trials 

• Key challenges associated with working with global CROs 

Torsten Kayser, PhD Senior Fellow Clinical Research, Boston Scientific, Belguim 

Post-Market Clinical Requirements 

17.00 Practically meeting post-market clinical study requirements and impact of the revision of 

the MDD 

• Outlining the current MEDDEV 2.12/2 rev 2 (2012) guidance on PMCFU 

• Assessing how widespread regulatory surveillance (Sentinel/Eudamed) may be used in the 

post-market phase: Would this be limited to adverse event reporting or wider use 

• Practical advice on meeting post-market clinical study requirements 

• Understanding how the revision of the MDD will impact vigilance implementation for 

medical devices 

• Examining how to put in place a good robust PMS programme including for high risk 

devices 

Ryan Magee, Global Post Market Compliance Manager, Senior, Boston Scientific, USA 

17.35 Implications of MDD revision on setting up post-market clinical follow-up (PMCFU) 

• Clarifying how PMCFU requirements will change with the revision of the MDD and how 

this will impact industry 

• Reviewing how PMCFU fits into the overall post-market surveillance (PMS) strategy 

• Reviewing exactly when a PMCFU should be carried out 

• Exploring how and when industry should work with a Notified Body when carrying out 

PMCFU and the discussions that should occur 

• Overcoming the key challenges associated with carrying out PMCFU 

• Designing a PMCFU study that takes into account endpoints and measurement points that 

will be also useful for health economics 

Martine Callaert, Clinical Trial Project Manager EMEA, Terumo BCT Europe N.V., 

Belgium 

18.10 End of conference day two 

13.10 Networking lunch 

Post-Conference Workshop Y Friday 26 April 2013 

Practical Advice on Successful Use of Software, Electronic Data Capture and Apps for Clinical Evaluations and Investigations 

Registration is at 08:30 for a 09:00 start. The workshop will finish no later than 16:00. Workshop documents, refreshments and lunch will be provided. 

Practical advice on using software and apps for clinical evaluations and investigations 

• Exploring guidelines available for use of software and apps for clinical evaluations and investigations 

• Reviewing current software and apps available for medical device clinical evaluations and 

investigations 

• Evaluating software and app developments and what is coming up in the future 

• Understanding how use of software and apps can be beneficial for industry 

Exploring the use of electronic data for clinical evaluations and investigations 

• Understanding the use of an electronic trial master file (eTMF) and how this can benefit industry 

• Assessing the use of randomisation systems for use of clinical studies and how these can benefit 

industry 

• Clarifying current guidance available for electronic submissions and whether there are any changes 

coming up 

Erik Vollebregt, Partner, Axon Lawyers, The Netherlands • Alex Denoon, Partner, Lawford Davies Denoon, UK • Mathias Klümper, Partner, Lützeler Klümper Wachenhausen, Germany 



Fax: +44 (0) 20 7017 7823 Email: registrations@informa-ls.com Please quote CQ7104

8th Annual Clinical Evaluations and Investigations for Medical Devices

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