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Interventional Vs. Non-Interventional Study Classification in the European Union: Would my Study Remain Non-Interventional if I use Direct-to-Patient Contact Methods?
November 4, 2016 @ 10:00 - 11:00 UTC+0
Interventional Vs. Non-Interventional Study Classification in the European Union:
Would my Study Remain Non-Interventional if I use Direct-to-Patient Contact Methods?
Webinar date & time:
Friday, November 4, 2016 at
- 10:00 am - 11:00 am EST (NYC, USA)
- 2:00 pm - 3:00 pm GMT (London, UK)
- 3:00 pm - 4:00 pm CET (Paris, FR)
Xavier Fournie, MD -
- As Mapi Group Corporate Medical Director since January 2008 and Executive Vice President of Mapi Real World Evidence since 2009, Dr. Fournie plays a leading role in the development and maintenance of professional relationships with a variety of audiences (including medical/scientific community, health authorities, patient advocacy groups and Industry), oversees medical monitoring services and develops a culture of ethical and regulatory compliance across Mapi business units. He provides input to successfully bridge clinical, commercial and legal considerations.
- He has held various posts over his three decades of tenure with the Mapi Group including market research and clinical research project management, clinical operations leadership, general management of central lab activities, medical direction, Quality Assurance and Regulatory Affairs direction, and pharmacovigilance management.
- From 2001 Dr. Fournie led the development of an independent unit within the Mapi Group, ProClinica™, dedicated to multi-country direct-to-patient contact management for proactive PRO data collection and patient assistance in studies.
- Dr. Fournie has practiced as a GP for 4 years in hospitals and private practices in France and Germany. He has additional qualifications in Medical Law (Forensic Medicine), Sports Medicine, and Aviation Medicine. He is also an active member of the ENCePP Working Group 1 “Research Standards and Guidances” and of the French and European CRO federations (AFCROs/EUCROF).
Jean Siebenaler, MD, MPH -
- Dr. Siebenaler is a Senior Medical Director within Mapi’s Real World Evidence group. She is a U.S. licensed Family Physician with over 20 years of military and private medical practice experience in disease diagnosis and inpatient and outpatient health management of adults and children. Over the past 14 years, she has held increasing levels of executive leadership positions within contract research organizations (CROs), providing strategic patient-centered consultation to clients and project teams, therapeutic guidance in global study protocol designs, medical monitoring services in multiple therapeutic conditions, and expert input to study-related publications.
Sandra Wiederkehr, PhD -
- Sandra Wiederkehr has managed several academic and pharmaceutical projects, including in Canada, where she spent more than 4 years, also keeping part of her activity for clinical and cognitive assessments and management of neurologic/psychiatric patients (traumatic brain injuries, strokes, mild cognitive disorders, Alzheimer’s disease and related dementia, Parkinson’s disease and other movement disorders, uni/bipolar disorders…). She joined Mapi’s Direct-to-Patient Contact Unit in 2011 where she acts as a Project Director. She works with the operational team to ensure successful high quality project implementation and achievement, as well as promotes a Direct-to-Patient Contact approach in the clinical environment. Sandra has a PhD in Clinical Neuropsychology from Laval University (Québec, Canada) and has published several articles in peer-reviewed journals.
Mapi invites you to join our upcoming 60-minute webinar hosted by industry experts Xavier Fournie, Jean Siebenaler and Sandra Wiederkehr.
The new European Regulation on Clinical Trials (No 536/2014) introduced a subtype of clinical trials called “Low-intervention Clinical Trial.” This label is confusing when trying to categorize and differentiate it from a non-interventional study, especially when patient reported data are collected through the use of Direct to Patient Contacts (DPC) conducted outside the context of routine clinical care visits. The DPC approach may be interpreted by some as simply an extension of routine clinical care visits (i.e., non-interventional) and by others as imposing additional diagnostic or monitoring procedures to clinical care (i.e., interventional).
Waiting for further official clarification on this topic, Mapi experts will present a perspective from their extensive DPC experience incorporated into non-interventional study designs. A practical checklist will be provided that can serve as an aid in planning and categorizing studies with patient-centric strategies.
Who Should Attend:
This presentation is designed for participants from the healthcare industry involved in the design and regulatory submission of post-authorization study protocols.
Therefore, individuals from the following departments are welcome to participate:
- Medical Affairs, Regulatory and Data Protection, Quality Assurance, Pharmacovigilance and Pharmacoepidemiology, Medical Writing, Biometrics, Clinical Operations and Patient-Centered Outcomes
Key Learning Objectives:
- Understanding the current and forthcoming regulation that govern post-authorization studies in EU;
- Understanding the component of a study classification as interventional vs non-interventional; and the concerns raised by the new European Clinical Trial regulation;
- Understanding the DPC approach in post-authorization clinical studies:
- Quantitative and qualitative analyses of submissions outcomes to ethics committees/competent health authorities performed by Mapi
- How often did a DPC approach lead to a study-reclassification as interventional?
- How often EC/CA requested additional information? Which topics?
- Reviewing a proposed criteria checklist to complement those of the ENCePP position paper published in 2011.
Register to attend now: