The document provides information on the organizers, program committee, and agenda for the 2nd European Conference on Clinical Research being held from February 2-4, 2015 in Paris, France. The pre-conference on February 2nd will focus on how clinical procurement can provide strategic value beyond cost reductions. The main conference on February 3rd-4th will involve presentations and debates on key issues in clinical research regulation, new technologies, risk management, and the patient's role. Topics will include the impacts and challenges of the new EU Clinical Trials Regulation and new operational practices in clinical trials.

1. Organisers
 Stefano Marini, President (Italy)  Dagmar Chase, Vice-President (Germany)  Yoani Matsakis, Treasurer (France)  Darina Hrdlickova, Secretary (Czech Republic)  Christophe Golenvaux, Member (Belgium)
 Yoani Matsakis  Véronique Marty  Denis Comet  Michel Lévy
Programme Committee Pre-Conference  Philippe Van der Hofstadt (Co-Chairman), BeCRO  Lan Bandara (Co-Chairman), PCMG  Christophe Golenvaux, BeCRO  Véronique Marty, AFCROs  Gill Roberts, PCMG  Claus Horst, BVMA
Conference  Michèle Garot (Chairman), BeCRO  Darina Hrdlickova (Vice-Chairman), ACRO-CZ  Carmen Martínez, AECIC  Xavier Fournie, AFCROs  Antoinette van Dijk, AICRO  Dagmar Chase, BVMA  Martine Dehlinger-Kremer, BVMA  Yoani Matsakis, AFCROs  Véronique Marty, AFCROs The European Federation of CROs (EUCROF) is pleased to invite you to the forthcoming European Pre-Conference and Conference on Clinical Research that will be held in Paris, France from 2-4 February 2015. This year, the Pre-Conference will be organised on 2 February 2015 by EUCROF in collaboration with PCMG (Pharmaceutical Contract Management Group). The Pre-Conference is a privileged opportunity for representatives of the R&D outsourcing teams of the pharma industry and their counterparts in CROs to exchange and share views on key business issues and trends to develop a collaborative outcome for the benefit of both parties. This year the Pre-Conference will examine the role of outsourcing / procurement functions in clinical development from a perspective not focusing solely on cost reduction: we will review how this group can add value through the use of category management techniques to support performance management. The main Conference will be organised on 3-4 February 2015. In a changing regulatory environment, this conference will be a unique opportunity for high level presentations and debates through several round-table discussions, involving all stakeholders of clinical research in Europe (Pharmaceutical industry, biotech, medical devices industry, CROs as well as other service providers, patient associations, regulatory authorities, ethics committees, key representatives from the academic sector …). The media will be present to reflect on the most current issues in domains as regulations, new technologies, risk and performance management and data sources while patients’ role becomes every day more central. We look forward to welcoming you in Paris! Yoani Matsakis, Chair of the EUCROF Conference 2015 Michèle Garot & Darina Hrdlickova, Chairs of the Conference Programme Committee Philippe Van der Hofstadt & Lan Bandara, Chairs of the Pre- Conference Programme Committee

2. 2nd European Conference on Clinical Research - 2-4 February 2015 | Paris-France
Programme details
Day 1 - Pre-Conference
“Is there more to clinical procurement than price reductions?”
2 February 2015
08.00 – 09.00
Registration & Welcome Coffee
09.00 – 12.40
Session 1: Does procurement provide strategic value?
Chairs: Gill Roberts, Global Strategic Sourcing Manager, Global R&D Services, Bayer Healthcare Procurement, United Kingdom & Dr. Claus Horst, Senior Director, Global Strategic Clinical Procurement, PAREXEL International, Germany
The term “Procurement” is often associated with a competitive bidding process to deliver price reductions. In this session we will review how purchasing functions can realise extra value through strategic initiatives and category management techniques. Participants will be asked to vote on questions at the end of the session and also at the end of the day.
09.00 - 09.40
Procurement as strategic function in clinical development James Carson, Director, Category Leader, Takeda Development Centre Europe Ltd, United Kingdom
09.40 – 10.20
Delivering Value Beyond Savings – CRO and Sourcing building sustainable strategic business cases Paula Gildert, VP Global Head Development Strategic Sourcing, Novartis Pharma AG, Switzerland
10.20 – 11.00
Coffee Break
11.00 – 11.40
CRO Procurement Adding Value to Outsourced Trials Dr. Claus Horst, Senior Director, Global Strategic Clinical Procurement, PAREXEL International, Germany
11.40 – 12.40
Does procurement deliver strategic value? – Panel discussion
Panelists:
Mike Ryan, Chief Business Officer, A’Bing Ltd, United Kingdom
Alex Slater, Regional Sales Director EU & AP, Covance Central Laboratory Services, United Kingdon
James Carson, Director, Category Leader, Takeda Development Centre Europe Ltd, United Kingdom Paula Gildert, VP Global Head Development Strategic Sourcing, Novartis Pharma AG, Switzerland
12.40 – 14.20
Lunch
14.20 – 17.30
Session 2: Performance management and metrics
Chairs: Philippe Van der Hofstadt, CEO, B&C Group, Belgium & Lan Bandara, BSc PhD, Director, Clinical Outsourcing, Eisai Limited, United Kingdom
As our industry has matured through the implementation of different outsourcing models, performance management has become a critically important area of focus. Metrics and key performance indicators (KPIs) are now well established terms and this session will cover the use of metrics within clinical research and also in other industries.
14.20 – 15.00
Case study on using metrics in process improvements / performance management
Elena Bolaños, Senior Director of Clinical Operations, Europe, Eli Lilly, Spain
15.00 – 15.30
Feedback from EUCROF/ PCMG Working Group on KPIs
Lan Bandara BSc PhD, Director, Clinical Outsourcing, Eisai Limited, United Kingdom
15.30 – 16.10
Coffee Break
16.10 – 16.50
Aligning strategic goals across the value chain through performance management Marc Slegers, Vice President Global Supply Market Lead, Liberty Global and Vice President Supply Chain & Procurement at Telenet, Belgium
16.50 – 17.30
Quality oversight in performance management
Geoff Taylor, Director Clinical Quality Assurance, Eisai Limited & Martial Verschoot, MSc, Exec. Dir., Global Customer QA Leads,Quintiles
18.00
Welcome cocktail
2

3. 2nd European Conference on Clinical Research - 2-4 February 2015 | Paris-France
Day 2 - Conference & Exhibition
“Regulations, technologies, risk management, data sources, patients' role ... Will reality match expectations?”
3 February 2015
08.30 – 09.30
Registration & Welcome Coffee
09.30 – 09.45
Welcome message Dr Stefano Marini, MD, MFPM, EUCROF President
09.45 – 10.15
Introductory Speech
Prof. MUDr. Cyril Höschl
We have already come a long way since the first clinical trial on scorbut a century ago! In this introductory speech some of the major success stories of clinical research will be reviewed as well as some of the key milestones in progressing towards the current state of the art.
Looking backwards enables to better highlight the future perspectives that will be addressed throughout the two days conference. New regulations and ethical requirements, higher pressure from the public through the media and patient associations, a tremendous acceleration of clinical research in new regional areas across the world, new revolutionary technologies are completely reshaping the landscape of clinical research.
10.15 – 12.45
Session 1: Will the Clinical Trials Regulation fulfil its promises? Highlights and Lowlights Chair: Dr Dagmar Chase, Vice-President, EUCROF & Managing Director, Clinrex GmbH
The application of the EU Clinical Trials Regulation is coming closer and time flies! There is not a single stakeholder who will not be heavily impacted by this new piece of legislation. The content of the Regulation – in the meantime probably more or less known by the audience – will be discussed by all parties involved. After an introductory presentation by a regulator, ethics committees, pharmaceutical industry and CROs as well as patients and academia will have the word to draw attention to the benefits and challenges from their point of view. A round table dialogue will surface any obstacles for which we all have to get prepared!
10.15 – 10.45
Keynote speech Prof. Luca Pani, MD, Director General of the Italian Medicine Agency (AIFA)
10.45 – 11.00
Coffee Break
11.00 – 12.00
Key stakeholders perspective
Representatives of key stakeholders (regulators, pharmaceutical industry, academia, patients, CROs, …) will expose their respective perspectives.
Pharma Industry: Sini Eskola, Director, Regulatory Affairs, European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium
Patients Associations: Dr Petra Wilson, Chief Executive Officer, International Diabetes Federation, Belgium
Ethics Committees: Prof. Dr Joerg Hasford, Chair of the Ethics Committee of the Medical Association in Bavaria, Chair of the Working Group of Medical Ethics Committees in Germany
Academia: Cristina Avendaño Solá
CROs: Dr Dagmar Chase, Vice-President, EUCROF & Managing Director, Clinrex GmbH
12.00 – 12.45
Round table with all stakeholders
Representatives of all stakeholders will then debate on whether this new Regulation will fulfil its promises and discuss highlights and lowlights.
3

4. 2nd European Conference on Clinical Research - 2-4 February 2015 | Paris-France
12. 45 – 14.00
Lunch Break
Visitors will have the opportunity to visit the booths in the sponsor exhibition.
Sponsors will have the possibility to organise side events in the privatised rooms on the first floor.
Press lunch: The media will be invited for a press lunch with key representatives of the hosting organisations (EUCROF and AFCROs) and in presence of the PR Officer of the event.
14.00 – 16.00
Session 2: New Operational Practices, reality or utopia? Chair: Dr Michèle Garot, MD, Executive Director, Head Quality Management, Western Europe, Quintiles, Belgium
Clinical studies have always been delivered using a very traditional monitoring model with on-site source data verification. Under the impulse of the FDA and European Medicines Agency which promote a Risk Based approach, new monitoring models are emerging generating enthusiasms but also questions when converting concepts into practices. As those practices are evolving, ICH GCP is also being revised.
This session will provide the most recent update on the ICH GCP revision and very concrete operational insight in Risk Based Quality Management.
14.00 – 15.15
Presentations
ICH GCP, a new revision is underway, early impressions
Gabriele Schwarz (invited), Head of GCP Inspectorate, Federal Institute for Drugs and Medical Devices, BfArM, Bonn, Germany
Pharma view on Risk Based Quality Management
Ann Meeker-O’Connell, Senior Director, Clinical Strategy Team Lead, R&D Quality Assurance – Pharma R&D Q&C, Johnson & Johnson, New Jersey, USA
Are we ready to embrace Risk Based Quality Management?
Dr Yvonne Rollinger, Managing Director, OmniComm Europe GmbH, Bonn, Germany
Investigative Sites ‘s view on Risk Based Quality Management
Dr Emiliano Calvo, MD PhD, Director, Clinical Research START Madrid, Centro Integral Oncológico Clara CampalHospital Universitario Madrid Norte Sanchinarro, Madrid, Spain
15.15 – 16.00
Round table discussion
Speakers will be invited to anticipate the future and highlight the potential challenges or barriers on the implementation pathway, therefore identifying domains or topics where collective work will still be required to further boost adoption of new monitoring models.
16.00 – 16.30
Coffee Break
16.30 – 18.00
Session 3: The pulse on recruitment in Europe Chairs: MUDr. Darina Hrdličková, MSc, Director, Clinical Management, PPD Czech Republic & Carmen Martínez Hidalgo, M.Sc. Director, Clinical Management, Spain PPD
Members of the European Parliament have voted overwhelmingly to introduce a raft of legal measures to increase the transparency of clinical trials in Europe and remove disparity in the time required to obtain approval to conduct clinical trials in Europe. These legal measures along with the increased role of patient associations, public and social media and recruitment organisations will help doctors and patients to make better informed decisions about which treatment is best.
The purpose of this session will be to discuss how all of the above will/could impact patient recruitment in clinical research. In the round table we will learn about the views of the representatives of the key players in this business: the CROs, ethics committees, patient associations, recruitment organizations and the media.
16.30 – 17.15
Presentations
Which of the current drivers for change will be positively influencing patient participation to clinical trials: the view of patient associations
Virginie Hivert, PhD, Therapeutic Development Director, Rare Diseases Europe (Eurordis), Paris, France
4

5. 2nd European Conference on Clinical Research - 2-4 February 2015 | Paris-France
General Public Media: a key partner in Clinical Research?
Representative of “The Guardian” - Speaker to be confirmed
What is the true definition of global patient recruitment?
Scott H. Connor, Vice President, Acurian Inc., Horsham, PA, USA
17.15 – 18.00
Round table discussion – perception of Clinical Research
Clinical Research is firstly designed to serve the interests of the patients and / or future patients. However, is this a concept widely spread in the European population? How is Clinical Research actually perceived by European citizens? Is the guinea pig paradigm behind us or still in the background? To what extend do the general media become a “stakeholder” of Clinical Research? A panel of personalities from different horizons will debate these issues and interact with the audience.
20.30 – 23.00
Social event : cruise dinner on the Seine
Book a table on board of ship SAPHIR for a nice evening dinner on the Seine in the middle of the historic Paris to further network with your preferred partners or just enjoy the dinner and the place.
Day 3 - Conference & Exhibition (continued)
4 February 2015
08.00 – 09.00
Registration & Welcome Coffee
09.00 – 10.30
Session 4: Medical devices, paediatrics, rare diseases, many challenges on the Clinical Research pathway Chairs: Antoinette Van Dijk, MD,MFPM, Senior Director Cardiovascular and Endocrinology, Clinical Development, Post Approval and Strategic Services, INC Research & Dr Martine Dehlinger-Kremer, Global Vice President Medical and Regulatory Affairs, SynteractHCR, Germany
In Clinical Research some specific areas are evolving rapidly. Areas with similarities to the traditional clinical studies , but at the same time with very specific requirements or approaches.
The medical device sector will be regulated by the new EU Medical Device Regulation; what changes and challenges will this bring in particular to clinical evaluation and investigations with devices? Are manufacturers ready for these new requirements and how will Notified Bodies' practices align?
Clinical Research in a paediatric population and in rare diseases are requiring a different approach and set up to be successful. The involvement of existing patient associations and patient and parent networks can be of key importance. Some highlights and examples will be presented in the next session, leading subsequently to a possibility for open discussion.
Presentations
Medical Devices: Key Changes and Challenges with the new European Medical Devices Regulation; present and future with a focus on clinical evaluation and clinical investigations
Dr Dario Pirovano, Senior Regulatory Adviser, Eucomed, Medical Technology
Paediatrics: Working together to optimise paediatric drug development: Industry at the interface between legislation and networks
Mark Turner, Chair, European Network of Paediatric Research at the European Medicines Agency & Senior Lecturer in Neonatology, University of Liverpool, UK
Rare Diseases: Clinical research in rare diseases, what is different and how best to deal with this ?
Filippo Bucella, President Parent Project Italy and Board Director United Parent Projects for Muscular Dystrophies, Rome, Italy
5

6. 2nd European Conference on Clinical Research - 2-4 February 2015 | Paris-France
10.30 – 11.00
Coffee Break
11.00 – 12.30
Session 5: Patient centric approaches in clinical development and real world evidence data generation Chair: Dr Xavier Fournie, Corporate Medical Director/EVP Global Medical Affairs, MAPI, France
Patients have an increasing role in the benefit/risk assessment of health products. From patient needs exploration to patient satisfaction and adherence assessment in the real-world, their input is valuable all over the development and post-marketing phases. As the final “consumer”, they represent a critical pathway for the actual product use; they are now to be integrated as Health Care Decision Making actors. The traditional strategies focusing on KOL/prescribers conviction and Clinician Reported Outcomes are no longer sufficient. Pharma Industry has to evolve and integrate patient-centric approaches to achieve medical, pharmacovigilance and market access objectives. Regulators, Agencies, Payers have societal expectations and specific challenges to manage. Clinicians, hospitals and clinics have to deal with new patient behaviors.
The purpose of this session is to apprehend 3 aspects about the patient centric approaches:
 What are the benefits and limits of integration of patient perspective in clinical trials to prepare real world evidence data generation in the post marketing setting?
 What are the strategic challenges for pharma companies: is patient centricity inevitable? How medical affairs should evolve?
 What are the health authorities (regulators, agencies, HTA assessors and payers) expectations and challenges about Patient Focused Outcomes?
Presentations
Mixed method Research in the Clinical Research setting: A chimeric view or the ideal solution to address the challenge of patient centric research
Benoit Arnould, PhD, Senior Director, Global Patient-Centered Outcomes, Mapi HEOR & Strategic Market Access, Lyon, France
Patient focused outcomes: expectations & challenges for Regulators and HTA bodies
Dr Mira Pavlovic, MD, Deputy Director for HTA, Haute Autorité de Santé (HAS), EUnetHTA JA2 WP7 Lean Partner SEED Coordinator, Saint Denis, France
Strategic challenges for Pharma companies: the medical affairs perspective
Gavin Collins, Senior Director Medical Affairs Effectiveness, EMEA, Celgene, Switzerland
12.30 – 14.00
Lunch Break
14.00 – 16.00
Session 6: Clinical Research in 2020 Chair : Yoani Th. Matsakis, President, Telemedicine Technologies, France
In this session we perform a prospective review of the main factors that shall be expected to significantly influence how clinical research will be performed in a decade from now, and we consider propositions or recommendations on how stakeholders in the EU shall anticipate such changes. As this session is the closing one, topics developed in previous sessions will also be considered under this prospective perspective. A part of the session will be dedicated to presentations on additional topics to complete the overall prospective panorama. Will the current upsurge of connected devices and technologies for mobility (mobile health) be a major factor for change? Shall we expect a significant convergence between clinical & epidemiological research and care processes? Shall the “21 CFR Part 11 gold standard” be revised to introduce the concept of Trusted Third Parties Hosting Services? What role will personalised medicine play in the future?
14.00 – 15.40
Presentations
The upsurge of connected devices and mobile health systems, social networks, new challenges for data protection?
Pierre-Yves Lastic, chairman of the board CDISC, and Associate Vice-President, Chief Privacy Officer at SANOFI, Paris, France
6

7. 2nd European Conference on Clinical Research - 2-4 February 2015 | Paris-France
Convergence between clinical research and care processes : the EHR4CR case
Pr Dipak Kalra (tbc), EuroRec, EHR4CR Managing Entity, London University, UK
Towards Trusted Third Parties Hosting services providers for EDC systems?
Alan Yeomans, Pharma Consulting Group in Uppsala AB, Sweden
Personalised medicine
Pr Dr Horst Domdey, Managing Director, BioM Biotech Cluster Development GmbH, Martinsried, Germany
15.40 – 16.00
Questions and Answers
Discussion will involve a selection of panellists of the two days conference and the audience through a twitter wall or a live poll system. The discussion will elaborate on key points of concern and on practical propositions or recommendations on how stakeholders in the EU shall anticipate the expected changes.
16.00 – 16.30
Closure speech
Stefano Marini, MD, MFPM, EUCROF President
Registration and hotel reservation
Early fee – up to 31 October Late fee – after 31 October
Pre-Conference – 2 February 375,00 EUR 575,00 EUR
Conference – 3+4 February 575,00EUR 775,00EUR
Pre-Conference + Conference – 2+3+4 February 775,00EUR 975,00EUR
Conference – One day – 3 OR 4 February 375,00 EUR 575,00 EUR
Rates include 20% French VAT
Registration and hotel reservation can be done online via www.eucrof-conference.eu. Pre-registration will close on 26 January 2015. After this date only onsite registration in Paris will be accepted.
Networking programme
On Monday 2 February, a welcome cocktail will be held at the conference venue to which all Pre-Conference and Conference delegates are invited.
On Tuesday 3 February, delegates can book a table on board of the ‘Bâteau Mouche’ Saphir for a nice evening dinner on the Seine in the middle of the historic Paris to further exchange with your preferred partners or just enjoy the dinner and the place.
Conference venue
Les Salons Hoche 9 Avenue Hoche, 75008 Paris www.salons-hoche.fr Ideally located between the "Prestigious Paris" and the "Business Paris", just steps away from the Place de L'Etoile and Monceau Park, the Salons Hoche offer a blend of prestige, character, and serenity.
7

8. 2nd European Conference on Clinical Research - 2-4 February 2015 | Paris-France
Sponsors