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SCDM 2016 European Leadership Forum
March 9, 2016 - March 11, 2016
About ELF 2016
Announcement of the Second European CDM Leadership Forum!
March 9-10, 2016 | Uppsala, Sweden
Following the success of the inaugural European Leadership Forum in 2014, the Society for Clinical Data Management (SCDM) has the pleasure to announce the second European Leadership Forum.
The SCDM 2016 European Leadership Forum – To 2020: A Data Odyssey is hosted by the Uppsala Monitoring Centre and takes place in Uppsala, Sweden, on March 9-10, 2016.
With this exclusive event*, SCDM seeks to engage European CDM leaders, regulators and other stakeholders in a dialogue surrounding key CDM topics and emerging trends.
An agenda full of key industry topics is waiting for the participants on the second day of the Forum. The focus of the keynote and the following session is going to be on the impact of mHealth systems and devices on Clinical Data Management and Clinical Research. The subsequent session on key CDM issues such as eCOA and Risk Based Approaches to Quality Management. Finally, in the last sessions, participants have the opportunity to brainstorm and discuss how the new quality paradigm may affect Clinical Data Operations.
We are looking forward to another successful European Leadership Forum in 2016.
The Society for Clinical Data Management
*Please note that this is an invitation only event. Are you an experienced professional in a senior management, CDM related position and possibly also responsible for a team? Email us to express your interest to attend the SCDM 2016 European Leadership Forum.
Networking Reception & Walking Dinner
Join your peers and colleagues at the Networking Reception at the historic Linnaeus Garden. Enjoy great networking opportunities and a walking dinner in the 200 years old Orangery located in the Botanical Garden.
DAY 2 – Thursday 10 March 2016
Uppsala Konsert & Kongress
Opening of the Forum
Session 1: mHealth
Facilitated by Yiannis Karageorgos (BMS)
Phil Coran (Medidata), Pierre-Yves Lastic (Sanofi) and Erica Sage (InVentiv Health)
mHealth systems and devices are expected to help improve health outcomes. But is their data trustworthy enough to be used in support of an NDA?
Fika Paus (Coffee Break)
Session 2: The Boundaries of Controlling eCOA
Facilitated by Albert Hage (Astellas), Pieter Voermans (F.Hoffman-LaRoche Ltd.), and Julie Risser (F.Hoffman-LaRoche Ltd.)
Valdo Arnera (ERT) and Begoña Gonzalez (Lilly)
In this session, we will follow a great part of the lifecycle of a data point. A singular data point, one which is coming directly from where it came to life, from the patient. The journey starts with the conception of a data point at a sponsor. The next phase will be a joined effort of the sponsor and the eCOA vendor to ensure the best start of the data point in the real world; by selecting the modality to collect the data, the settings and to ensure a seamless use and understanding of the users. When the study is in the execution phase the data point is on her/his own and is interacting with many different people, how does it work in reality, what are the challenges for this data point to reach its destination? At the end, after a meaningful life, there will be a well deserved retirement.
Session 3: Risk-Based Quality Management: Role of CDM
Facilitated by Crona O’Conallain (Quintiles) and Peter Stokman (StokmanPharmaConsulting)
Gunnar Danielsson (PCG) and Magda Borda (Roche)
Risk-based Quality Management made its way into clinical development via Risk based Monitoring: instead of 100% SDV, a smarter approach leads to higher quality. The thought-provoking EMA reflection paper on Risk Based Quality management invited the industry to extend this approach throughout the whole field of clinical development. With the publication of the Addendum to ICH E6, the Risk-Based approach is no longer optional: when the Addendum is accepted, a Risk Based approach to Quality Management will be the new paradigm.
In this Session, the two speakers will address a conceptual framework to incorporate Risk Based Quality Management into Clinical Development, and the regulatory thinking regarding this approach.
Fika Paus (Coffee Break)
Risk-Based Quality Management in CDM
This Session will be highly interactive: breakout groups will be facilitated to brainstorm on how this new quality paradigm affects Clinical Data Operations. The breakout teams will be challenged to apply the quality elements that constitute the Clinical QMS Conceptual framework, like Processes, Roles & Responsibilities, Partnering, Risk Management and Continual Improvement to describe steps in the Data Operations process: Study build, Data Review, EDC /non-EDC reports, Outsourcing/working with outside partners, Documentation. What can we do to more explicitly integrate quality in our processes? What have we done so far; where are the gaps? What have other companies done? The timing of this exercise is great: at this time we can still talk about what we have to do; once the Addendum to GCP is effective, we can only refer to what we should have been doing.
Considering the leadership level of the participants, the multitude of companies, and the input of regulators, this session may be ground-breaking for the course of your Clinical Data Operation in the years to come.
Wrap Up & Next Steps
End of the Forum
SCDM 2016 European Leadership Forum TaskForce
- Emma Banks, Datatrial Ltd.
- Albert Hage, Astellas Pharma
- Malin Jakobsson, Uppsala Monitoring Centre
- Yiannis Karageorgos, Bristol-Myers Squibb
- Crona O’Conallain, Quintiles
- Steven Roan, Uppsala Monitoring Centre
- Peter Stokman, StokmanPharmaConsulting
- Pieter Voermans, Hoffman-LaRoche
Are you interested in becoming a sponsor of the SCDM 2016 European Leadership Forum? Email us at EULeadershipEvent@scdm.org! Together we can work on opportunities to help you capture the attention of high-level clinical data management professionals before, during and after the conference.