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

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

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

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

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