Joint EFGCP & DIA Better Medicines for Children Conference
From development to access
Description
Event | Conference |
Type | Face To Face |
Language | English |
Date(s) | 25 & 26 Oct. 2018 |
Day(s) | 2 Day(s) |
Duration | 7 hours/ day |
The Paediatric Conference “Better Medicines for Children” is an annual event jointly organised by EFGCP and DIA with a focus on new developments in children medicine.
In 2018, the event is proudly brought to the public under the name of “Better Medicines for Children Conference, From Development to Access” by the EFGCP Children Medicines Working Party in collaboration with DIA and Regulators with the aim to take stock of the progress achieved after 10 years of Paediatric Regulation and, to move the discussion toward the experience of patients.
It provides a unique platform where all the stakeholders involved in the process, from research to treatment of children diseases, including HTA and payers, as well as patients are invited to share updates in the field and discuss challenges related to the development of paediatric medicines.
The intention of this year event is to shade light on what could be done to optimise children’s access to new medicines. In the context of this conference, “access” can be broadly defined as :
- Inclusion of paediatric patients into clinical trials,
- Health authority approval of a new medicine and,
- Children’s access to a medicine that has been approved by regulators.
The unique programme of the 2018 event gives a new perspective over current status and developments in the paediatric treatment arena by addressing the three access perspectives.
In the opening, the conference will benefit of keynotes from Francoise Grossetête, Member of the European Parliament (France) and Florian Schmidt from DG SANTE, European Commission, followed by addresses from key speakers representing EMA, FDA, National Authorities, healthcare professionals, clinical researchers and patients.
Interactive breakout sessions will allow all participants to actively engage in the discussion to identify innovative solutions to address access issues specific to paediatric subpopulations, such as adolescents, or neonates. A Q&A session with members of the EMA Paediatric committee (PDCO), moderated by Dr Dirk Mentzer (PDCO chair) will help audience to understand PDCO's specific activities and priorities, and to further address clarifying questions to PDCO members.
A panel discussion held by patients and parents will highlight the priorities from a societal perspective and enable participants to reflect on the goals of paediatric research activities. Stakeholders recognize that more treatment access can be achieved by accelerating development of new medicines. Current delays in clinical trial conduct relating to recruitment difficulties will be addressed, e.g. by optimising the number of children needed for clinical trials, or recruitment strategies.
Information on constructive multi-stakeholder collaborations, which were set up to address the perceived long-term gaps will be provided; an opportunity to understand further what could help in fostering paediatric development and children’s access to new medicines. The conference will end with a panel discussion to explore what needs to be further achieved to meet the specific goal of, increasing children’s access to new treatments.
NEW: By means of a poster session, the conference will also show case some best practice examples of paediatric research & developments that address unmet medical needs in children and that have been successfully developed under the EU Paediatric Regulation.
The presenting authors of the winning posters will have the possibility to publish an abstract of their work in “Therapeutic Innovation & Regulatory Science” magazine.
Programme
08:30 |
Welcome & Introduction
Dirk Mentzer, EMA PDCO Chair, UK & PEI, Germany
Martine Dehlinger-Kremer, EFGCP & ICON plc, Germany
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Session 1: Setting the Scene - What is Done in Europe to Enhance Children Access to Medicines
Chaired By: Dimitrios Athanasiou, PDCO EMA, World Duchenne Organization / UPPMD and MDA Hellas, Greece Solange Corriol-Rohou, AstraZeneca, GMD, France |
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08:45 |
Keynote Speeches
Florian Schmidt, DG SANTE, EU Commission
Françoise Grossetête, Member of the European Parliament
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09:00 |
Panel Discussion |
Regulator view
Dirk Mentzer, EMA PDCO Chair, UK & PEI, Germany
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HTA view
Edith Frénoy,
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Payer view
Ri de Ridder, Doctors of the World, Belgium
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Patient view
Virginie Hivert, Eurordis, France
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Industry view
Samuel Blackman, CureSearch, USA
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Healthcare provider view
Dominique Haumont, Neonatal Medicine, Saint-Pierre University Hospital Brussels, Belgium
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10:30 |
Questions and Answers |
11:00 |
Coffee Break |
Session 2: Meet the Expert Sessions - Enabling Access for Different Paediatric Populations Christina Bucci-Rechtweg, Novartis Pharmaceuticals Corporation, USA |
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11:15 |
Breakout Sessions |
BOS 1 Adolescents Moderator(s): Dirk Mentzer, EMA PDCO Chair, UK & PEI, Germany
Samuel Blackman, CureSearch, USA
Solange Corriol-Rohou, AstraZeneca, GMD, France
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BOS 2 Neonates Moderator(s): Dina Apele-Freimane, P. Stradins Clinical University Hospital, PDCO Member, Latvia
Dominique Haumont, Neonatal Medicine, Saint-Pierre University Hospital Brussels, Belgium
Martine Dehlinger-Kremer, EFGCP & ICON Plc, Germany
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BOS 3 Children Moderator(s): Marieke van Meel, NephcEurope Foundation, The Netherlands
Angelika Joos, MSD (Europe), Belgium
Ri de Ridder, Doctors of the World, Belgium
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Session 3: Access Through Approval: View of the Regulators and Q&A Session with the PDCO Dirk Mentzer, EMA PDCO Chair, UK & PEI, Germany Martine Dehlinger-Kremer, EFGCP & ICON Plc, Germany |
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14:15 |
Q&A with PDCO Members
Dirk Mentzer, EMA PDCO Chair, UK & PEI, Germany
Hugo Tavares, Hospital Centre Vila Nova de Gaia / Espinho, Portugal
Koenraad Norga, Paediatric Oncology, University Hospital Antwerp, Belgium
Ninna Gullberg, Medical Product Agency, Sweden
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15:30 |
Coffee Break |
Session 4: Access after Marketing Authorisation - Sharing Experience from the Patient's Perspective Dimitrios Athanasiou, PDCO EMA, World Duchenne Organization / UPPMD and MDA Hellas, Greece Katie Rizvi, Youth Cancer Europe, Romania |
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16:00 |
An overview on the different systems of patients access in Europe
Solange Corriol-Rohou, AstraZeneca, GMD, France
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16:15 |
Case study: Patient perspective
Elizabeth Vroom, United Parent Projects Muscular Dystrophy, The Netherlands
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16:30 |
Spinraza case study: Patient perspective
Mencía de Lemus, SMA Europe, Spain
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16:45 |
Access to essential medicines
Anca Colita, Fundeni Clinical Hospital, Romania
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17:00 |
Payer perspective
Ri de Ridder, Doctors of the World, Belgium
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17:15 |
Panel discussion Moderator(s): Dimitrios Athanasiou, PDCO EMA, World Duchenne Organization / UPPMD and MDA Hellas, Greece Katie Rizvi, Youth Cancer Europe, Romania |
17:30 |
POSTER SESSION Moderator(s): Claudio Fracasso, Pfizer, Italy |
18:00 |
Social Event (The Hotel, networking cocktail)
Chris Copland, ACCELERATE platform’s FAIR, Unite2Cure, National Cancer research Institute, United Kingdom
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08:15 |
Welcome Coffee |
Session 5: Access Through Clinical Trials: Enhancing Effectiveness in Paediatric Clinical Trials Sabine Fürst-Recktenwald, F. Hoffmann-La Roche, Switzerland |
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08:45 |
EnprEMA Working Group on Clinical Trial Preparedness
Angeliki Siapkara, MHRA, United Kingdom
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09:05 |
Connect4Children - Pan-European Paediatric Clinical Trial Network
Mark Turner, University of Liverpool, United Kingdom
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09:25 |
Think Big Project Proposal - Remote and Decentralised Clinical Trials
Kimberly Hawkins, Sanofi, France
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09:45 |
Use of wearables in Paediatric Clinical Trials - the experience of Aparito
Elin Haf Davies, Aparito, United Kingdom
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10:05 |
General Discussion |
10:45 |
Coffee Break |
Session 6: Facilitating Access : Multistakeholders' Collaborations & Best Practices Angelika Joos, MSD (Europe), Belgium Marieke van Meel, NephcEurope Foundation, The Netherlands |
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11:15 |
Identification of Paediatric Needs
Begonya Nafria Escalera, Patient Engagement in Research Coordinator, Research Institute Sant Joan de Déu, Spain
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11:30 |
Multistakeholder Paediatric Strategy Forum
Gilles Vassal, Institut Gustave Roussy, France
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11:45 |
European Reference Networks
Ruth Ladenstein, ERN, Austria
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12:00 |
Panel Discussion
Dirk Mentzer, EMA PDCO Chair, UK & PEI, Germany
Marieke van Meel, NephcEurope Foundation, The Netherlands
Samuel Blackman, CureSearch, USA
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12:45 |
General Discussion Q&A |
13:15 |
Lunch |
Session 7: Changing the Landscape of Paediatric Research & Access Duane Schulthess, VitalTransformation, Belgium |
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14:15 |
Introduction & Panel Discussion |
FDARA: what to expect in the US?
Gregory Reaman, CDER, FDA/OCE, USA
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Do our children get access to the new medicines? Nordic Experience
Pirkko Lepola, Helsinki University Hospital, Department of Children and Adolescents, Finland
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HTA view |
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Payer view
Menno Aarnout, International Association of non-profit healthcare payers, (AIM), Belgium
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Regulator view
Dirk Mentzer, EMA PDCO Chair, UK & PEI, Germany
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Company view
Marie-Yvonne Douste-Blazy, Servier, France
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Changing the landscape of paediatric research: Real world data, real world experience and data protection
Dominique Haumont, Neonatal Medicine, Saint-Pierre University Hospital Brussels, Belgium
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Patient view
Emily Crossley, Duchenne / HERCULES project, United Kingdom
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15:30 |
Conclusions
Dirk Mentzer, EMA PDCO Chair, UK & PEI, Germany
Martine Dehlinger-Kremer, EFGCP & ICON Plc, Germany
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16:00 |
End of Conference |