EFGCP Better Medicines for Children Conference 2024

Common issues in clinical development amplified in paediatric drug development

Description

Event Conference
Type Face To Face
Language English
Date(s) 22 & 23 Oct. 2024
Day(s) 2 Day(s)
Duration 2 Days

The EFGCP “Better Medicines for Children” Conference is an annual flagship event providing a unique opportunity to share best practice, reflect on what has happened since we last met in October 2023, and discuss paediatric updates with a truly global outreach. Despite an ever changing and challenging environment, we believe we have been able to organise a dynamic, innovative, and highly engaging conference to inform our delegates of the latest scientific and regulatory developments in the paediatric space.

 

Last year, when we met in October 2023, gave us the opportunity to finally reconnect in person after 3 years of virtual conferences due to the pandemic. This year will also be an in-person conference to happen in Brussels, at the Crowne Plaza Airport Hotel.

 

The conference will focus on Common issues in clinical development amplified in paediatric drug development, its challenges and solutions, and in particular its value, with a focus on what can be done and has been achieved in Europe, and this year also in the US and globally. To this effect, the conference will bring together distinguished speakers from all around the world and relevant stakeholders and experts involved in paediatric medicines development.

 

On Day One, further to a Key Note focusing on Mental Health and Neurologic Disorders in Children, there will be the opportunity to discuss implications of the new Mechanism of Action Paediatric Investigation Plan, which while considered a child-centric option,  is a new option considered by Policy makers who are still working on the revision of the Pharmaceutical Legislation.  Examples of successful EU-funded paediatric projects. One session will focus on multi-stakeholders’ collaboration knowing a number of initiatives are already planned to start in 2024, which will benefit all involved in medicines development including children. The last session will provide the opportunity to discuss the Potential of Artificial Intelligence in Paediatric Drug Development

 

Active engagement of conference delegates will be welcomed in Breakout Sessions to share learnings, discuss challenges and identify solutions on what could be done to optimise childrens’ access to new medicines, with a focus on the important topics:

1.    Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials.

2.    Use of Real-World Data/Registries in Paediatric Drug Development.

3.    Paediatric-only medicines development/First in child companies.   

 

 

 

Day two will provide the opportunity to share Paediatric Collaboration Activities at the Global Level with a panel of regulators from various regions, such as Africa & Middle East, Japan, Australia, Canada, Europe, and the USA. This session will be complemented by a session on Childrens’ Access to Medicines in Developing Countries. Prior to sharing the feedback from Day 1’s Breakout Sessions, Health Technology Assessment (HTA) of Paediatric Medicines will be explored, to better understand what sponsors will be facing with the implementation of the HTA Regulation in early 2025.

 

The Programme Committee looks forward to welcoming you all at the conference for a global educational and networking event that is a unique opportunity to learn from one another, to meet and interact with experienced colleagues and experts from all over of the world.

With the Support of

Gold

Programme

Tuesday 22 October 2024
09:00 Registration and welcome coffee
10:00 Introduction to the Conference
Begonya Nafria-Escalera, Barcelona Children’s Hospital & eYPAGnet
Martine Dehlinger-Kremer, ICON & EUCROF
10:15 KEY NOTE – Treatment of Psychiatric Disorders in children and adolescents: current situation and needs for research
Carmen Moreno, Hospital Gregorio Maranon
10:45 Session 1: Neuro Health • Depression • Paediatric Irritability: From Definition and Assessment to Treatment • MS
Moderator(s): Sara Carucci, Università degli studi di Cagliari
Argyris Stingaris, University College of London
Benedetto Vitiello, University of Turin
Christoph Correl, Charité Berlin
Lauren Wyatt, ADHD Foundation
Louisa Braun Exner, PDCO representative Denmark
11:45 Session 2: Mechanism of Action Paediatric Investigation Plan
Moderator(s): Gesine Bejeuhr, Bayer Gilles Vassal, Gustave Roussy Institute
Angelika Joos, MDS
Chrissi Pallidis, European Medicines Agency
Sylvie Benchetrit, PDCO, EMA
12:45 Lunch
13:45 Session 3: Examples of successful EU-funded paediatric projects: • VISION-DMD • ALPHA-MAN • Lena Project • HIP PUMA
Moderator(s): Christina Kyriakopoulou, European Commission Mark Turner, Liverpool University Hospital
Michiyo Sakiyama and Natsuko Hayama, Pharmaceuticals and Medical Devices Agency
14:45 Breakout session
1. Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials: impact and benefits for both mother and child
Moderator(s): Martine Dehlinger-Kremer, ICON & EUCROF Solange Corriol-Rohou, AstraZeneca
Corinne de Vries, European Medicines Agency
Lynne Yao, FDA
Marie Teil, UCB
2. Use of RWD/Registries in Paediatric Drug Development
Moderator(s): Angeliki Siapkara, AstraZeneca Jeffrey Barrett, Aridhia
Katherine Donegan, MHRA
Marina Kolochavina, Five Voices Consortium
Roberto De Lisa, EMA
3. Paediatric-only drug development First in child companies
Moderator(s): Gesine Bejeuhr, Bayer Rhian Thomas-Turner, Noah's Ark Children's Hospital for Wales
Cesare Sapon, Oncohereos
Marc Ramis, Venture capital
Sam Blackman, Day One Biopharmaceutical
16:30 Coffee break
17:00 Session 4: The Potential of Artificial Intelligence in Paediatric Drug Development
Moderator(s): Claudio Fracasso, Hippocrates Research Srl Thomas Severin, Novartis
Danielle Belgrave, GSK
Roberto De Lisa, EMA
18:00 Reflection from the PDCO Chair
Brian Aylward, Health Products Regulatory Authority
18:30 End of Day 1
Martine Dehlinger-Kremer, ICON & EUCROF
Wednesday 23 October 2024
08:00 Welcome coffee
08:30 Welcome and Debrief from Day 1
Begonya Nafria-Escalera, Barcelona Children’s Hospital & eYPAGnet
Martine Dehlinger-Kremer, ICON & EUCROF
08:45 Session 5: Regulatory updates
Moderator(s): Fahimeda Ali, MHRA Sabine Fuerst- Recktenwald, Roche
Michiyo Sakiyama, Pharmaceuticals and Medical Devices Agency
Natsuko Hayama, Pharmaceuticals and Medical Devices Agency
Robyn Langham, Therapeutic Goods Administration
Yashwant Sinha, Therapeutic Goods Administration
09:45 Session 6: Pathways to Medicines in Developing Countries: • Access to Childhood Cancer Medicines (WHO) • Access to Medicines Foundation. They have a published methodology on assessing medicines specifically in developing countries.
Moderator(s): Martina Penazzato, WHO Rhian Thomas-Turner, Noah's Ark Children's Hospital for Wales
Emmanuella Amoako, Yemaachi Biotech
Lenias Hwenda, Medicines for Africa Foundation
Moy Bracken, Access to Medicines Foundation
10:30 Coffee break
11:00 Session 7: Multi Stakeholder Collaboration in 2024
Christina Kyriakopoulou, European Commission
12:00 Lunch
13:00 Session 8: European Legislations impact on paediatric medicines
Moderator(s): Angeliki Siapkara, AstraZeneca Anja Schiel, Norwegian Medicines Agency Dimitrios Athanasiou, EUPATI
Brian Aylward, Health Products Regulatory Authority
Fabio D’Atri, European Commission
Mark Turner, Liverpool University Hospital
Victoria Kitcatt, Pfizer
14:00 Feedback from the Breakout Sessions:
1. Inclusion of Pregnant and Breast Feeding Individuals in Clinical Trials
2. Use of Registries in Paediatric Drug Development
3. Paediatric-only journey companies / First in child companies
15:00 End of Day 2 – Conclusion & Farewell
Begonya Nafria-Escalera, Barcelona Children’s Hospital & eYPAGnet
Martine Dehlinger-Kremer, ICON & EUCROF