Program & Speakers – EMEA Leadership Forum

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PROGRAM

DAY 1

Time  Wednesday, 30 May 2018
11:00  –  12:00 Registration & Badge Collection Opens
12:30 – 13:30 Welcome Lunch
13:30 – 14:00 Opening Keynote Lecture – Risk

  • Dawn Anderson, Deloitte (USA)
14:00 – 15:30 Session 01 – EMEA CDM Community Panel
Facilitated by Yiannis Karageorgos, BMS (Belgium)This session will gather representatives of national and international data management societies. They will present their mission, vision and perhaps challenges. Together, they will discuss how they can collaborate and create synergies within the CDM landscape in the EMEA region.

  • SCDM, Jonathan Andrus, Clinical Ink, USA
  • DMB, Michel Arnoult, Arnoult.org, France
  • ACDM, Ioannis Karagergos, BMS, Belgium
  • CDM in Israël, Irina Sher, Bioforum, Israël
  • CDM, an African Perspective, Tanya du Plessis, IQVIA, South Africa
  • PSDM, Albert Hage, Astellas, Netherlands
  • INCDMA, Peter Stokman, Bayer, Germany
  • Panel Discussion
15:30 – 16:00 Coffee Break 
16:00 – 18:00 Session 02 – eSource & New Data Protection Regulations

  • Regulatory Perspective on eSource and Data Protection
    Lisbeth Bregnhøj, Danish Medicine Agency (Denmark)
  • Practical Experience of eSource
    Jonathan Andrus, Clinical Ink (USA)
  • A Site Perspective
    Vivienne van de Walle, PT&R (Netherlands)
  • Q&A and Panel Discussion
19:30 – 22:00

Networking Reception

The Networking Reception will offer a unique opportunity to connect with pairs, while enjoying a fine walking dinner in the historical building 41 Portland Place, home of the Academy of Medical Sciences since 2010. Profits generated through venue hire of 41 Portland Place are used to fund activities run by the Academy of Medical Science to promote advances in medical science and ensure research is rapidly translated into benefits for patients.

Venue:
41 Portland Place

DAY 2

Time  Thursday, 31 May , 2018
08:00 – 08:30 Registration & Badge Collection
08:30 – 10:00

Session 03 – RBQM & First Experiences with ICHE6 (R2)
Facilitated by Peter Stokman, Bayer (Germany)

  • From Creation to Implementation of RBQM
    Andy Lawton, Boehringer Ingelheim (United Kingdom)
  • Approach to RBM
    François Torche, Cluepoints (Belgium)
  • Implementing RBM
    Chris Wells, F. Hoffmann – La Roche Ltd. (United Kingdom)
  • Q&A and Panel Discussion
10:00 – 10:30 Coffee Break
10:30 – 12:30

Session 04 – Breakout Sessions
Facilitated by Peter Stokman, Bayer (Germany)

  • Introduction
  • CSV & Audit Trails
    Virginie Wieter, F. Hoffmann – La Roche Ltd. (Switzerland)
  • RBM in CDM – How to bring both worlds together?
    Alison Liddy, ICON (Ireland)
  • Evolution of CDM/CDR – Capture the future of Data Management
    Pieter Voermans, F. Hoffmann – La Roche Ltd. (Switzerland)
  • Further reflections on eSource
    Lisbeth Bregnhøj, Danish Medicine Agency (Denmark)
  • Deliberation and interactive discussion
12:30 – 13:00 Session 05 – Partners’ Symposium

  • Clinical Ink – Jonathan Andrus (USA)
  • Veeva – Hugo Cervantes (USA)
13:00 – 14:00 Lunch
14:00 – 15:30

Session 06 – Other Perspectives on RBM and New Developments
Facilitated by Tanya du Plessis, IQVIA (South Africa)

  • Investigator’s perspective
    Vivienne van der Walle, PT&R (Netherlands)
  • The CRA’s perspective
    Miguel Valenzuela, Bayer (Netherlands)
  • Patient advocacy organization’s perspective
    Virgil Simons, The Prostate Net (Spain)
  • Q&A and Panel Discussion
15:30 – 16:00 Closing Keynote Lecture, Tanya du Plessis, IQVIA (South Africa)

SPEAKERS

Dawn Anderson
Deloitte Managing Director,
R&D Life Sciences Consulting

Dawn has more than 30 years of industry and consulting experience in Pharmaceutical, Biotechnology, CROs, and Technology companies. Her practice is focused on Clinical Development and she works with clients to design and deploy global operating strategy, performance improvement and technology implementations across the development of new drugs, biologics and devices.
Dawn is a frequent speaker on Clinical Transformation and the future of clinical trials including topics around Adaptive Design, Protocol Complexity, Risk Assessments and Central Monitoring, Patient Centricity, Virtual Trials, mHealth, and the use of Social, Mobile, Clinical Analytics and Cognitive Automation in transforming clinical trial delivery.
Prior to joining Deloitte, Dawn held executive clinical leadership positions at Global Pharmaceutical, Biotechnology, CROs and Technology Companies

Lisbeth Bregnhøj, MSc Pharmacy, PhD
Medicines Inspector, GCP and PhV, Danish Health and Medicines Authority, Medicines Control & Inspection

Lisbeth has been a GCP and pharmacovigilance inspector at the Danish Health and Medicines Authority since 2006. Prior to that, she has experience from the authority perspective on regulatory affairs and authorization of clinical trial protocols (1993-1999), from a research and hospital perspective (Clinical pharmacology at a University Hospital in Denmark 1999-2005) and from working in the medicinal industry (GCP auditor 2005-2006).

Lisbeth has performed numerous GCP (and PhV) inspections, both national inspections on behalf of the Danish Health and Medicines Authority and international inspections on behalf of the European Medicines Agency in various settings such as sponsor sites, CRO sites and investigator sites.

Lisbeth is part of the GCP Inspectors Working Group and of the sub group, authoring the European Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials.

Andy Lawton has extensive experience in computing, statistics, data management, RDC, system design, Quality Management, Risk Based Approach in both CSV and clinical trials.

He is currently consultant and director of Risk Based Approach Ltd. Previously, Andy held a variety of positions in the NHS and Pharmaceutical industry.  Andy was a Founding Committee Member of ACDM and TransCelerate RBM work stream. Publications include the TransCelerate papers in the TIRS Journal, for which he won “best author of the year 2015 and 2016”.

Virgil H. Simons, MPA Founder & President The Prostate Net
Barcelona, Spain/Newark, NJ, USA

Virgil Simons is the Founder & President of The Prostate Net, a non-profit patient education and advocacy organization committed to providing credible and actionable information that will minimize the negative impact of prostate cancer. Using the experiences gained as a 21-year survivor of prostate cancer and a patient advocate, he has built, over the past 19 years, an international organization that uses a matrix of informational and interventional techniques to address disease risk awareness, early disease interdiction and advanced stage disease management.

François Torche
Chief Executive Officer, CluePoints

François holds a Master in Business Administration from the ICHEC School of Management, Brussels, Belgium. Over the past 18 years in the pharmaceutical industry, he has held positions as statistical programmer, SAS and JAVA developer and IT project leader for companies such as GSK, UCB and IDDI. During his ten-year tenure with IDDI as an IT Specialist, Mr. Torche assisted in the development of the SMART™ engine, a patent-pending software solution and the underpinning of CluePoints. Francois has served as CluePoints’ Chief Executive Officer since the company’s inception in 2012.

Miguel Valenzuela
Quality & Compliance Senior Manager, P&O CDO Quality & Compliance

Mr. Valenzuela (Miguel) has been in the industry since 1996, in roles such as informatics and compliance consultant, and managing risk management and oversight groups.  In 2011, Miguel joined Bayer.  There he has driven the clinical operations department’s development and implementation of Bayer’s Risk Based Monitoring Approach.  In his current role, he is driving the implementation of Bayer’s Quality by Design IT solution, and clinical operation’s Countinous Improvement governance process.

Vivienne van der Walle, The Netherlands
PT&R Co-founder & Owner

Vivienne van de Walle studied medicine both at the University of Maastricht and at the University of Oxford. In 2004 she successfully defended her thesis for her PhD and in 2011, she passed the CPI exam. She has always combined clinical research with patient care and has been a full time investigator at independent clinical research sites. She co-founded and owns the independent research site PT&R (www.ptr.nu) since 2006. Her entrepreneurship is reflected by her skills in consulting, education, management, leadership and executive functions at CROs, Farma and trade organizations i.e. ACRP, SCRS, TransCelerate and NVFG. She started her carrier as a participant in a clinical trial. As a result, Vivienne has a unique perspective of the various sides of the table in clinical research and is eager to share her many years of experience.

Chris Wells, United Kingdom
Statistical Scientist, Roche Products Limited

BSc Decision Sciences – University of Hertfordshire
MSc Medical Statistics – London School of Hygiene and Tropical Medicine

Chris has been employed at Roche Products for the last 10 years as a Biostatistician and has been the team lead for Statistical Monitoring for the past 2 years.

For more information about this event, please contact:

Diane Zaleski, SCDM 2018 EMEA LF Project Manager

Tel: +32 2 740 22 37
E-mail: dzaleski@scdm.org