EUCROF Konferansı 7-9 Ekim 2013’te Brüksel’de…


EUCROF Conference 2013

“The Future of Europe in the Worldwide Scene of Clinical Research”

The future of Europe in the worldwide scene of Clinical Research

The European Federation of CROs is pleased to invite you to the forthcoming European Pharmaceutical Pre-Conference and Conference that will be held in Brussels.

This event will provide a unique opportunity to listen to worldwide expert speakers from Regional and National Authorities, Pharmaceutical Industry and global CROs and will be of interest to all actors engaged in clinical research, with a primary focus on the European region.

The aim of the Pre-Conference “Clinical Outsourcing: Converting Promise to Delivery” on 7 October 2013 is to provide a balanced interactive forum for representative “stakeholders” working in clinical research and development from pharmaceutical companies and outsourcing service providers. In 3 sessions, we will share information and insight from outsourcing practices and provide direction to strategic thinking on outsourcing for the future.

The main Conference on 8-9 October 2013 will address multiple facets of this highly evolving environment, considering how clinical research is responding to the global landscape, stressing the specific challenges and strengths which characterise the three main regions being the Americas, Europe and Asia.

A series of regulations and guidances will shortly reshape the clinical research landscape in Europe. Expert speakers will provide insight in the essential features of these new frameworks. We will review how the future

Clinical Trial Regulation will transform access to Clinical Trials in Europe, also hearing from National Agencies and Ethic Committees preparing for this ambitious change. Risk based Quality Management will also be a point of focus, balancing expectations from the regulators and the perspective of Pharmaceutical Companies facing challenges on the implementation pathway.

We will critically assess how the fast changing digital technologies may offer opportunities for innovative ways of delivering Clinical Trials, considering inherent risks and challenges associated with them.

The Patient Associations will join this conference to highlight the most significant barriers to a prosperous clinical research.

Michèle Garot & Philippe Van der Hofstadt

Chairs of the EUCROF Conference 2013

Programme details

EUCROF Pre-Conference 2013

“Clinical Outsourcing: Converting Promise to Delivery”

Pre-Conference Day – 7 October 2013

09.30 – 10.00 Registration & Welcome Coffee

10.00 – 10.15 Welcome & Opening of the EUCROF Pre-Conference

Mr Philippe Van der Hofstadt – President of BeCRO, Chief Executive Officer of B&C Group, Belgium

Interactive participation of the audience is facilitated during the Pre-Conference through Twitter/SMS-Wall technology

10.15 – 12.30 Session 1: Is there a Holy Grail in Clinical Outsourcing Models?

Chair: Mr Shalabh Kumar – Management Consultant oNirvana, United Kingdom


Mr Graham Belgrave – Senior Vice President, Head, Global Clinical Development Operations, Global Compound Development,

Grunenthal GmbH, Germany

Mr Eric Chleide – Strategic Resourcing Director, GlaxoSmithKline Vaccines, Belgium

Mr Nicholas Lakin – Director Strategic Business Unit R&D Solution, Cognizant Technology Solutions, United Kingdom

Dr Christoph Schnorr – Vice President Drug Development Consulting Europe, Quintiles, Germany

The session will reflect on the various outsourcing models which have been tried in clinical research in the last decade.

For each of the models, the panel will present a challenging proposition and recommend a direction for the future based

on their combined experience as sponsors and service providers. The areas that will be covered in the discussion include:

• Full Study Outsourcing or Functional Outsourcing? As a pharma company, you have to pick one as your main outsourcing


• Is it preferable to work with 2-3 ‘Partners’ than to have multiple ‘Preferred Providers’?

• Can a 100% Offshoring model be 100% effective?

• Is Insourcing to be considered as an Outsourcing model or more a “workload management tool”?

12.30 – 13.30 Lunch

13.30 – 15.45 Session 2: How does a contract grow into a relationship?

Chair: Mr Michael Ryan – Senior Vice President, Global Business Development, inVentive Health Clinical, United Kingdom


Mr John Mulders – Sourcing Manager Clinical, Janssen R&D, Belgium

Mr Andy Parrett – Lead CRO Services, AstraZeneca, United Kingdom

Mr Christian Buhlman – Vice President Business Development, Parexel, Germany

Dr Benedikt Van Nieuwenhove – President EMEA, SynteractHCR, Germany

This session will focus on developing successful outsourcing relationships between Pharmaceutical Companies and CROs by

focusing on getting the arrangement right from the start. The panel will provide real life examples illustrating various areas:

• Developing the contract into a roadmap for collaboration

• Performance objectives vs contract payment terms

• The role of risk sharing arrangements

15.45-16.15 Coffee Break

16.15-17.45 Session 3: Do we learn lessons from previous experiences?

Chair: Mr Graham Belgrave – Senior Vice President, Head, Global Clinical Development Operations, Global Compound Development,

Grunenthal GmbH, Germany


Dr Anna Matranga – Senior Director Outsourcing, Ipsen, France

Ms Annegret Vander Aa – Head Clinical Operations, Galapagos, Belgium

Mr Stuart McGuire – Vice President Global Business Development, Chiltern, United Kingdom

Mr Richard Young – Director, Regional Sales (EMEA), Medidata Solutions Worldwide, United Kingdom

During this session the arrangement in implementation will be discussed. The area includes:

• How to minimize vendor oversight on outsourced activities?

• “Micro-management vs hands-off”. How to find the right balance?

• Differences in oversight between full service CROs and functional providers?

17.45-18.00 Concluding remarks of the EUCROF Pre-Conference

Live Pre-Conference evaluation via Twitter/SMS Wall

18.00-20.00 Welcome reception of the EUCROF Conference

11.15 – 12.45 Session 2: Worldwide Clinical Research, the Regional Perspective, Strengths or Weaknesses?

11.15 – 11.40 Clinical Research in Asia

Ms Pey Ni Chan – Japanese CRO Association (JCROA), Managing Director, CMIC Asia-Pacific Pte Ltd., Singapore

11.40 – 12.05 Clinical Research in the Americas

Mr Douglas Peddicord – Ph.D., Executive Director, Association of Clinical Research Organizations (ACRO), USA

12.05 – 12.30 Clinical Research in Europe

Mr Roger Newbery – European Vice President Clinical Management, PPD, United Kingdom

12.30 -12.45 Discussions

12.45 – 14.00 Lunch

14.00 – 15.30 Session 3: Risk Based Quality Management

14.00 – 14.25 EMA Reflection Paper on Risk Based Quality Management, the European Medicines Agency Perspective

Mr Fergus Sweeney – Ph.D, Head of Compliance and Inspection, EMA, UK (invited, to be confirmed)

14.25 – 14.50 FDA Guidance for Industry: Risk Based Approach to Monitoring, the Food and Drug Administration Perspective

Ms Ann Meeker-O’Connell – Acting Division Director, Good Clinical Practice Compliance, U.S. Food and Drug Administration,

CDER, OC, Office of Scientific Investigations, USA (invited, to be confirmed)

14.50 – 15.15 Risk Based Quality Management: A Sponsor Perspective

Mr Albrecht de Vries – MSc, CCRA – Global Quality & Compliance Head, Quality Systems, Pharmaceutical R&D Quality &

Compliance, Janssen-Cilag B.V., The Netherlands

15.15 – 15.30 Questions

15.30 – 16.00 Coffee Break

16.00 – 17.30 Session 4: Proposal for the New Regulation on Clinical Trials on Medicinal Products for Human Use

16.00 – 16.25 The Future European Landscape

Mr Fabio D’Atri – Medicinal Products, Quality, Safety and Efficacy, Health and Consumers Directorate-General, European

Commission, Belgium

16.25 – 16.50 Ethics Committees Perception

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

16.50 – 17.15 National Competent Authorities Perception

Dr Greet Musch – Director-General DGPRE, Federal Agency for Medicines and Health Products, Belgium

17.15 – 17.30 Questions

18.30 – 23.00 Networking event in the Magritte Museum: visit of the famous collection followed by a buffet dinner

Conference Day 2 – 9 October 2013

08.00 – 10.00 Welcome Coffee

08.00 – 10.00 Session 5: Parallel Workshops led by EUCROF Working Groups

Each workshop will be organised from 08.00-08.50 and repeated from 09.00-09.50, participants are invited to register to 2

workshops out of 4

• Paediatric Working Group

Dr Martine Dehlinger-Kremer – Chair of the working group, Global Vice President, Regulatory Affairs, RPS Inc, Germany

o Ethical challenges in clinical trials

• Late Phase Working Group

Mr Denis Comet – Co-chair of the working group, Chief Executive Officer, Axonal, France

o Do we need a common regulation for conducting international observational studies?

• Early Phase Working Group

Mr Arnoud Huisman – Co-chair of the working group, VP Global Business Development Early Development Services

PRA International, The Netherlands

Mr Joris Wilms – Member of the working group, Vice President, Clinical Trial Services, KLIFO, Denmark

o Single European volunteer registration system

o European accreditation and certification of phase I units

• Medical Devices Working Group

Dr Susanne Gerbl-Rieger – Chair of the Working Group, Director of Compliance and Safety Department, CROMSOURCE,


o Changes in new Medical Device Regulation: impact on clinical research and market approval

10.00 – 11.00 Session 6: Low Risk Studies

10.00 – 10.25 Low Intervention Clinical Trials, Current Challenges and Future Perspectives

Speaker tbc

10.25 – 10.50 Population Studies: Principles and Opportunities

Prof Albert Hofman – Erasmus University in Rotterdam, The Netherlands

10.50 – 11.00 Questions

11.00 – 11.30 Coffee Break

11.30 – 13.00 Session 7: New Approaches in Clinical Trials

11.30 – 11.55 Clinical Trial Simulation: a Centrepiece in

the Model-based Drug Development

Prof Jean-Pierre Boissel – Claude Bernard University in Lyon, France

11.55 – 12.20 eLabel & Smart Technologies in Clinical Supplies

Ms Hilde Vanaken – Director, Clinical Trial Innovation, Janssen, Belgium

12.20 – 12.45 Next Leap in eClinical Trials

Mr Yoani Matsakis – President, Telemedicine Technologies S.A.S., France

12.45 – 13.00 Questions

13.00 – 14.15 Lunch

14.15 – 15.45 Session 8: Patient Participation in Clinical Trials

14.15 – 14.40 The Role of Patient Advocates in Clinical Research

Ms Susan Knox – Executive Director, EUROPA DONNA, The European Breast Cancer Coalition, Italy

14.40 -15.05 Patients, Active Stakeholders

Dr Albert Jovell – Ph.D, MA, MS, President Spanish Patient Forum, Director of Global Institute of Public Health and Health Policy

& Member of the Council of Government and Associate Professor in Health Sciences and Public Policy, International University

of Catalonia, Spain

15.05 – 15.30 Patient Vision for Clinical Research, Balancing Fears and Expectations

Patient Association tbc

15.30 – 15.45 Questions

15.45 -16.15 Closing remarks

Dr Stefano Marini – President of EUCROF, Italy