Scientific programme

17 October 2016



10:00 - 11:30

Press Morning


Exhibition Opening

11:30 - 12:30

Registration & Welcome Coffee Break

1st Morning Session: Opening of the Conference (Panorama Hall)



12:30 - 12:45

Welcome Message

Dr. Stefano Marini
President EUCROF

12:45 - 13:30

Key Note Speech

Michael Engsig
Executive Director, Clinical Management Central and Eastern Europe, PPD

2nd Afternoon Session: Regulatory News: EU Regulation 536/2014 and ICH-GCP Addendum (Panorama Hall)

Moderators: Dr. Dagmar Chase, Vice-President EUCROF, Managing Director Clinrex GmbH, Dr. Ulrike Lorch, Medical Director, Richmond Pharmacology, Ltd.



13:30 - 13:55

Regulation 536/2014: Status Quo from EFPIA perspective

Sini Eskola
Director, Regulatory Affairs; EFPIA - European Federation of Pharmaceutical Industries and Associations

13:55 - 14:20

The EU Portal: A Gate to Simplified Clinical Research?

Anabela Marçal
Head of Committees and Inspections Department, Inspections, Human Medicines Pharmacovigilance & Committees Division, European Medicines Agency (EMA)

14:20 - 14:40

Coffee Break

14:40 - 15:05

Transparency in Clinical Research of Medicinal Products: Pre and Post Marketing Authorisation

Dr. Holger Maria Rohde
Director, Strategy Implementation Lead
Merck Serono | Strategy and Business Operations Global R&D

15:05 - 15:35


15:35 - 16:20

ICH-GCP Addendum (including Discussion)

Gabriele Schwarz, PharmD
Head of GCP Inspectorate, German Federal Institute for Drugs and Medical Devices

16:20 - 16:40

Coffee Break

3rd Afternoon (Parallel) Sessions:

The Internet of Things and new paradigms in clinical research (Panorama Hall)

Moderator: Yoanni Th. Matsakis

Post-Marketing Approaches (Club E)

Moderator: Dr. Xavier Fournie, M.D.
Corporate Medical Director, Executive Vice-President, Global Medical Affairs - Real World Evidence, Mapi Group





16:40 - 16:55

From pharma to health Laboratories: how the Internet of Things is changing the way of delivering treatments

Vincent Varlet, Dr., MD, MBA, INSEAD
Executive Consultant – business transformation for healthcare companies

16:40 - 17:05

Non-interventional Studies: Different Types - Different Challenges

Giovanni Fiori, PhD, MPH
President and Scientific Director, MEDINEOS Observational Research, Italy

16:55 - 17:10

Cloud services, Internet of Things, Independant Third Party: new opportunities for CROs ?

Alan Yeomans
Quality Manager, PCG Solution; representing EUCROF WG on NT

17:05 - 17:30

Considerations on ENCePP and best pharmacoepidemiology methods for PASS

Prof. Nicholas Moore, MD, PhD, FRCP (Edin), FISPE
Head of Pharmacology Department of the University of Bordeaux; Head of Clinical Research of the University Hospital of Bordeaux; President of the International Society of Pharmacovigilance; Member of the Advisory board of ENCePP, France

17:10 - 17:25

The convergence of e-health & clinical research reshaping the stakeholders' landscape

Yoanni Th. Matsakis,

17:30 - 17:55

Interventional Vs. Non-Interventional Study Classification in the European Union: Would my Study Remain Non-Interventional if I use Direct-to-Patient Contact Methods?

Dr. Xavier Fournie, M.D.
Corporate Medical Director, Executive
Vice President, Global Medical Affairs - Real World Evidence, Mapi Group

17:25 - 17:40

Innovative ICT architecture with modular integrated component for new study profile:  SPRINTT study ICT structure

Eng. Gianluca Zia
CEO, Caretek s.r.l., Torino, Italy


17:40 - 18:10


17:55 - 18:15



Conference Dinner

18 October 2016

1st Morning Sessions: Quality by Design (Panorama Hall)

Moderator: Dr. Michèle Garot, Consultant, Belgium - Former Executive Director, Business Quality and Strategic Liaison, Quintiles



9:00 - 9:25

Risk based monitoring, is the reality matching the model?

Andy Lawton
Consultant, Former Global Head of Clinical Data Management, Boehringer Ingelheim Ltd, Germany

9:25 - 9:50

Any pitfalls in RBM implementation? the perspective of the Regulators

Gabriele Schwarz, PharmD
Head of GCP Inspectorate, German Federal Institute for Drugs and Medical Devices

9:50 - 10:15

Risk-based Monitoring, trends in the model implementation

Dr. Yvonne Rollinger
Managing Director, OmniComm Europe GmbH, Bonn, Germany

10:15 - 10:45


10:45 - 11:15

Coffee Break

2nd Noon (Parallel) Session:


Clinical Trials in the Paediatric Population (Panorama Hall)

Moderator: Dr. Martine Dehlinger-Kremer
Vice President Global Medical and Regulatory Affairs, SynteractHCR
Chair of the Paediatric Working Group, EUCROF

Clinical Trials with Medical Devices (Club E)

Moderator: Dr. Georg Mathis
President & CEO Appletree CI Group AG




11:15 - 11:40

Regulatory Situation 9 years after the implementation of the Paediatric Regulation

Dr Christoph Male, MD, MSc
Former Member of the PDCO at EMA and Associate Professor of Paediatrics, Department of Paediatrics, Division of Paediatric Cardiology, Medical University of Vienna, Austria

The new EU Medical Device Regulation - How will it change our lives?

Shayesteh Fürst-Ladani
Managing Director SFL Regulatory Affairs & Scientific Communication Ltd., Switzerland

11:40 - 12:05

The role of paediatric Networks and benefits in paediatric research

Mark Turner
Chair of the European Network for Paediatric Research at EMA, University, Liverpool, UK

Challenges of Clinical Research in the Surgical Field - How to Generate Clinical Evidence?

Ivo Schauwecker
Clinical Studies Manager, AO Foundation, Switzerland

12:05 - 12:30

Feasibility and challenges with paediatric clinical trials

Dr. Martine Dehlinger-Kremer
Vice President Global Medical and Regulatory Affairs, SynteractHCR
Chair of the Paediatric Working Group, EUCROF

Specific considerations of in vitro diagnostics

Jorunn Tverland
Clinical Trial Manager, Dako, Agilent Technologies, Denmark

12:30 - 12:50



12:50 - 14:15

Lunch Break

3rd Afternoon Session: Patient-centric Approach (Panorama Hall)

Moderator: Dr. Darina Hrdličková, Director, Clinical Management, PPD Czech Republic, s.r.o.



14:15 - 14:40

Patient Centric approaches – an overview

 Ingrid Klingmann, MD, PhD, FFPM, FBCPM
Chairman at EFGCP, President at PharmaTrain Federation asbl, Managing Director at Pharmaplex bvba, Belgium

14:40 - 15:05

Personalized Medicine: With Big Data to Better Health?

Prof. Dr. Horst Domdey
Managing Director, BioM Biotech Cluster Development GmbH Geschäftsführer, Germany

15:05 - 15:30

Data Privacy

Isabelle Abousahl
Entrepreneur, Alcoam by design; Former Director Data Management, Deputy Biometry, Global Drug Development, Ipsen Innovation, France

15:30 - 15:55

Big Data-Big Opportunity for Patient Associations and Clinical Trial Center

Prof. Giuseppe Banfi, MD, PhD
General Manager of San Raffaele Foundation, Italy

15:55 - 16:10


16:10 - 16:15

Closing Address

Dr. Stefano Marini
President EUCROF


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