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
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
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
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