8th & 9th
MARCH
2018
BRUSSELS
Patient centricity
in clinical research:
Hype or reality?
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Programme

Preliminary Programme

08 March 09 March
08:00-09:00 Registration & Welcome Coffee Registration & Welcome Coffee
15 min Conference Introduction Welcome day 2
Session 1 Session 1
09:00-11:00

Patient presentations/Testimonials about clinical trials


Moderators: Belinda Delys, Communication & Patient Relations Manager, Novartis, Belgium & Philippe Van der Hofstadt, Board Member at BeCRO, EU President, CSM, Belgium

Panel discussion and interaction with the audience through:

Patient recruitement, Patient retention, Patient after study & Reporting to patients


Moderator: Prof Yves Geysels, President ACRP.be & Dr Ken Getz, CISRP
  • Dr François Houyez, Treatment Information and Access Director/Health Policy Advisor, Eurordis, France
  • Patient recruitment initiatives beyond paper: social media a helpful tool?: Dr Vivienne Vandewalle, Co-founder & Owner, Independent site PT&R, The Netherlands
  • Dr Mitchell Silva, ENP Chair, Eupati Belgium
  • About patient support programmes: Mrs Helena Jordan, IQVIA (Quintiles-IMS)
  • Dr Stefan Mikus, Regional Clinical Site Lead, Director, Pfizer, Germany
  • Forecasting the Impact of Patient Centricity on Drug Development Operations and Performance: Dr Kenneth Getz, Associate Professor and Director, CSDD, Tufts University, Founder and Board Chair, CISRP (Center for Information and Study on Clinical Research Participation), USA
  • Mrs Margot Vanfleteren, Patient Expert, Eupati fellow, Manager Patient Engagement at Healthbank, Belgium
11:00-11:30 Break Break
Session 2 Session 2
11:30-13:00

Patient centricity and regulatory aspect


Moderator: Mrs Annabelle Bruyndonckx, Board Member, BRAS, Belgium

Awareness of clinical research/Public access to information


Moderator to be confirmed
  • Patient centricity from regulatory authorities perspective: Mrs Greet Musch, Director General Pre-Authorisation, Federal Agency of Medicinal and Health Products, Belgium
  • The Lay Summary - EMA initiative: Mrs Sini Eskola, Regulatory Affairs Director, EFPIA, Belgium
  • Human factors become a regulatory submission requirement: Mrs Theresa Scheuble, Head of East Coast Drug Delivery Systems, Janssen, USA
  • Mrs Annick Anderson, Director of Research Services, CISCRP (The Center for Information and Study on Clinical Research Participation), USA
  • ‘What the new EU Regulation on the protection of personal data means for informed consent and sharing and use of patients’ data: Mrs Katie Gallagher, Policy Advisor, European Patient Forum, UK
  • Dr Diane Kleinermans, Advisor to the Minister, Ministry of Public Health and Social Affairs
  • Direct to Patient shipments: update from Belgian Working Group and the international survey: Mrs Annabelle Bruyndonckx, Board Member, BRAS
13:00-14:00 Lunch Lunch
Session 3 Session 3
14:00-16:00

STAKEHOLDERS INVOLVEMENT IN TRIAL DESIGN/PRODUCT LIFE CYCLE


Moderator Mr Guy Yeoman, VP Patient Centricity, AstraZeneca, UK

E-tools patients in clinical research


Moderator: Philippe Van der Hofstadt, Board Member, Belgian Association of CROs, Belgium
  • Learn how AZ connects with patients to ensure their perspective is reflected in clinical trial and patient service solutions: Mrs Cathy Emmas PhD, Patient Centricity Partnership Director, AstraZeneca, UK
  • eConsent Transcelerate initiative: Mrs Hilde Van Aken, Transcelerate eConsent Workstream Leader, Janssen R&D Operations Innovation Director, Belgium
  • The IMI PREFER initiative and patient involvement at KCE and KCE Trials: Dr Irina Cleemput, Senior Expert Economical Analysis, KCE, Belgian Healthcare Knowledge Centre, Belgium
  • Decentralized clinical trials - VCT - siteless trials - remote trials (IMI initiative), a Janssen perspective: Bert Hartog, R&D Operations – Innovation Leader, Janssen Pharmaceutica, The Netherlands
  • "How do you integrate patient feedback in the product life cycle?: Mrs Theresa Scheuble, Director, R&D Primary Container & Device Pharmaceutical Development, Janssen, USA"
  • ePRO challenges from a regulatory perspective, sponsor responsibilities, liabilities: Mr Jan Breemans, Sr. Director Data & Documents Operations, Grünenthal, Germany
  • How do you take into account the patients' perspective in the design of clinical trials in oncology?: Prof. François Duhoux, Cliniques universitaires Saint-Luc, Belgium
  • e-Tools, Survey results of Investigatior sites: Mrs Vivienne Vandewalle, Co-founder & Owner, Independent site PT&R, The Netherlands
  • Nicholas Brooke Executive Director Patient Focused Medicines Development
  • Patient perception of e-Tools, how can it be included by other stakeholders: Dr Mitchell Silva, ENP Chair, Eupati Belgium
16:00-16-30 Break Closing remarks
Session 4
16:30-18:00

Early access to unmet medical needs


Moderator: Mrs Greet Musch, Director General Pre-Authorisation, Federal Agency of Medicinal and Health Products, Belgium
  • Regulatory perspective at European level and the perspective of the EU Commission, EMA: Mrs Greet Musch, Director General Pre-Authorisation, Federal Agency of Medicinal and Health Products, Belgium
  • Independent clinical research: role and perspective in the evolving landscape; cancer clinical research as a model: Dr Denis Lacombe, Director General, EORTC, Belgium
  • Early access to medicines in Europe: how to make compassionate use become a reality for all? Dr François Houyez, Treatment Information and Access Director/Health Policy Advisor, Eurordis, France
15 min Closing remarks
18:30-23:00 Dinner & Social Event