EFGCP & DIA Better Medicines for Children Conference

The future of paediatric medicines: putting patients at the heart of innovation and regulatory science

Description

Event Conference
Type Virtual Event
Language English
Date(s) 12 & 13 Oct. 2020
Day(s) 2 Day(s)
Duration 8 hours/ day

This year, in 2020, 13 years after the EU Paediatric Regulation came into force, our aim is to build on achievements and lessons learnt so far and to look at the future of paediatric drug development, with a specific focus on putting patients at the heart of innovation and regulatory science.

The opening panel session moderated by Fabio d'Atri (DG SANTE, European Commission) and involving key speakers representing EMA, FDA, National Authorities, Healthcare Professionals, and Industry, will be the opportunity to share updates in the field and discuss the future of the development of paediatric medicines: what to do more to be better at delivering innovations to children in needs? How the EC/EMA action plan has been progressed?

To give them even more attention, in a separate panel session, the Young Patients, will tell us what the future of paediatric drug development means and looks like for them.

Active engagement of conference participants is expected to discuss challenges and identify solutions on what could be done to optimise children’s access to new medicines:

  1. What data sources and digital technologies could bring to paediatric development on top of the use of extrapolation?
  2. How to best define children unmet medical needs?
  3. How to optimise the PIP process and regulatory approval


A fireside chat with PDCO moderated by Elin Haf Davies (Aparito) and involving the PDCO chair & vice-chair, will give the audience the opportunity not only to understand PDCO's specific activities and priorities but also to further address clarifying questions to PDCO members.

The value of multi-stakeholder collaborations has been shown, since an opportunity to address important scientific gaps, but what is ongoing to foster paediatric development?

The conference will also explore what drug development means for Paediatricians, and in particular during COVID-19 pandemic.

Programme

Monday 12 October 2020
12:00 Opening of conference
12:30 Welcome and introduction to the conference
Martine Dehlinger-Kremer, EFGCP & ICON Plc, Germany
OPTIMISING THE IMPLEMENTATION OF THE PAEDIATRIC REGULATION
12:45 Keynote: Where has progress been made and what remains to be discussed?
Fabio d’Atri, European Commission, DG Santé, Belgium
13:00 Panel discussion Fabio d’Atri, European Commission, DG Santé, Belgium
Ann Marie Janson Lang, Swedish MPA, Sweden
Elke Stahl, CTFG & Federal Institute For Drugs and Medical Devices (BfArM), Germany
Gilles Vassal, Institut Gustave Roussy, France
Koenraad Norga, EMA, Antwerp University Hospital, Belgium & Chair of PDCO, EMA, The Netherlands
Lynne Yao, FDA, USA
Solange Corriol-Rohou, AstraZeneca, France
13:50 Q&A session
Voice of Young Patients including Q&A
14:10 What does the future of paediatric drug development mean and look like for Young patients? Angeliki Siapkara, MHRA, United Kingdom Begonya Nafria Escalera, San Juan de Déu Children’s Hospital Barcelona, Spain
Anna Sherriffs, ScotCRN, United Kingdom
Daniel Marín, Young Advocate of Kids Barcelona, Sjd Children’s Hospital Barcelona, Spain
Ivett Jakab, EPF’s Youth Representative, Hungary
Rime Allouche, Kids France
14:40 Introduction to the breakout sessions
Martine Dehlinger-Kremer, EFGCP & ICON Plc, Germany
14:50 Break
15:10 Break - Out Sessions
Extrapolation / RWD in drug development Sabine Fuerst-Recktenwald, Roche, Switzerland Faculty
Andrew Thomson, EMA, The Netherlands
Cécile Ollivier, Aparito, United Kingdom
Femida Gwadry-Sridhar, Pulse Infoframe, Canada
Zinedine Metenani, UCB, Belgium
Identifying paediatric unmet needs Marie-Yvonne Douste-Blazy, Paediatric Expert, France
Anja Schiel, Norwegian Medicines Agency (NOMA) & EMA SAWP Chair
Gilles Vassal, Institut Gustave Roussy, France
Karl-Heinz Huemer, EMA PDCO, Austrian Medicines and Medical Devices Agency, Austria
Solange Corriol-Rohou, AstraZeneca, France
Regulatory overview: Optimising PIP processes and regulatory approval (PDCO & CHMP) Angeliki Siapkara, MHRA, United Kingdom
Angelika Joos, MSD, Belgium
Gesine Bejeuhr, Bayer, Germany
Rob Hemmings, Concilium, United Kingdom
Sabine Scherer, Vice-Chair, PDCO, EMA, The Netherlands & BfArM, Germany
17:00 Break
17:10 Fireside Chat Elin Haf Davies, Aparito, United Kingdom
Dimitrios Athanasiou, PDCO Patient Representative & EURORDIS, Greece
Koenraad Norga, EMA, Antwerp University Hospital, Belgium & Chair of PDCO, EMA, The Netherlands (Chair)
Sabine Scherer, Vice-Chair, PDCO, EMA, The Netherlands & BfArM, Germany
18:10 What Drug Development means for Paediatricians Angeliki Siapkara, MHRA, United Kingdom Rhian Thomas-Turner, NHS, United Kingdom Thomas Severin, Novartis, Switzerland
Rhian Thomas-Turner, NHS, United Kingdom
Robert Shaddy, Pediatrician-in-Chief, Children’s Hospital Los Angeles, USA
18:55 Break
19:00 Special Event: Presentation on last updates on c4c Elin Haf Davies, Aparito, United Kingdom Solange Corriol-Rohou, AstraZeneca, France
Mark Turner, University of Liverpool, United Kingdom
Tuesday 13 October 2020
10:30 Debrief from Day one and introduction to Day 2
Martine Dehlinger-Kremer, EFGCP & ICON Plc, Germany
10:45 Panel session on Patient Access Angeliki Siapkara, MHRA, United Kingdom Solange Corriol-Rohou, AstraZeneca, France
Evert Jan van Lente, AOK-Bundesverband, Germany
James Ryan, AstraZeneca, United Kingdom
Katie Rizvi, Youth Cancer Europe, Romania
Niklas Hedberg, EunetHTA, Sweden
12:15 Enpr-EMA: Clinical Trial preparedness & International collaboration Work Group Martine Dehlinger-Kremer, EFGCP & ICON Plc, Germany
Angeliki Siapkara, MHRA, United Kingdom
Pirkko Lepola, FinPedMed, Finland
12:35 Debrief & Conclusions from the breakout sessions
13:05 The Go- FAIR Initiative / Use Data Dimitrios Athanasiou, PDCO Patient Representative & EURORDIS, Greece Elin Haf Davies, Aparito, United Kingdom
Marco Roos, Leiden University Medical Center, The Netherlands
Nawel Van Lin, Duchenne Data Foundation, The Netherlands
Peter-Bram ‘t Hoen, Radboud UMC, The Netherlands
13:35 The FAIR (Fostering Age Inclusive Research) Initiative – Inclusion of Adolescents in Adult trials Katie Rizvi, Youth Cancer Europe, Romania Solange Corriol-Rohou, AstraZeneca, France
Christina Bucci-Rechtweg, Novartis, USA
Max Williamson, National Cancer Research Institute, United Kingdom
14:20 Conclusions & Farewell
Martine Dehlinger-Kremer, EFGCP & ICON Plc, Germany