The EUCROF Paediatric Working Group is pleased to present the first Training on
Essentials of Paediatric Clinical Research
What you need to know when preparing, conducting and monitoring paediatric clinical trials.
The training is going to take place in Madrid (Spain), on 24 October 2019, at C.N.I.O. (Centro Nacional de Investigaciones Oncológicas) C/ Melchor Fernández Almagro, Madrid.
Event Date, Time and Venue
24 October 2019 from 9:30 AM to 5:30 PM (CEST)
at C.N.I.O. (Centro Nacional de Investigaciones Oncológicas) C/ Melchor Fernández Almagro, Madrid.
Training Objective
- Provide an overview of the regulatory landscape for paediatric research, review specific and most important challenges with corresponding solutions in paediatric drug development.
- Following the training, the participants will be familiar with the ethical and regulatory issues, specific protocol considerations, Informed Consent and Assent processes, drug formulations, safety specificities, recruitment, enrollment, and clinical monitoring specificities, as well as site interactions, relationships with paediatric research networks and infrastructures. Participants will be prepared to plan and execute paediatric clinical trials in any of the age groups which will result in obtaining higher quality data.
Presenters
- Carmen Rodriguez, President AECIC
- Martine Dehlinger – Kremer, President EUCROF & VP Pediatric Development, Synteract
- Maria Jesùs Fernandez Cortizo, Head of Service of Evaluation of Pediatric Medicines Spanish Agency of Medicines and Medical Devices (AEMPS), Paediatric Committee (PDCO) Member at EMA
- Donato Bonifazi, CEO Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF)
- Begonya Nafria, Chair European Young Paerson’s Advocacy Group (eYPAGNet) & Patient Engagement in Research Coordinator, Institut de Recerca Sant Joan
de Déu - Alex Cvetkovic Mutañola, Executive Director Clinical Development Syneos Health
- Nira Garty, CEO Perfection CRO
- Nuria G Martinez-Alier, Senior Medical Director, IQVIA
- Sophia Romboli, Country Manager, Zeincro
- Jürgen Schäfer, Managing Director, Conreso GmbH
- Ian Vasicka, Investigator
- Pablo Rojo Conejo, Associate Professor, Complutense University of Madrid and Paediatric Infectious Diseases Specialist of Hospital 12 de Octubre, Madrid
Event Schedule
09:30 - 09:50
Registration
09:50 – 10:00
Opening Remarks
C. Rodriguez, AECIC M. Dehlinger – Kremer, EUCROF & Synteract
Session 1: Framework for Paediatric Drug Development
10:00 – 10:30
Global Regulatory and Ethical Considerations for Paediatric Drug Development
M. Dehlinger – Kremer, EUCROF & Synteract
10:30 – 11:00
Impact of EU Paediatric Regulation on Clinical Research
M. J. Fernandez Cortizo, AEMPS & PDCO
11:00 – 11:30
European Paediatric Research Networks and Infrastructures
D. Bonifazi, CVBF
11:30 – 12:00
Role of Children’ s Advocacy Groups in paediatric research
B. Nafria, eYPAGNet
12:00 – 13:00
Lunch
Session 2: Medical Considerations
13:00 – 13:30
Differences between Children and Adults, specifics of the different paediatric Age Groups and impact on Study Protocols & Assessments
A.Cvetkovic Mutañola, Syneos Health
13:30 – 14:00
Medical Devices in Pediatric Research
N. Garty, Perfection CRO
14:00 – 14:30
Drug Formulation specificities and administration
N. Martinez-Alier, IQVIA
14:30 – 15:00
Coffee break
Session 3: Monitoring and Safety
15:00 – 15:30
ICF and Assent: Specific process per Age Group
S. Romboli, Zeincro
15:30 – 16:00
Specific Study Monitoring considerations for Paediatric Trials
J. Schäfer, Conreso
16:00 – 16:30
Safety Considerations in Paediatrics
I. Vasicka, Investigator
16:30 – 17:00
Excellence in Paediatric Trials from the Clinical Site perspective
P. Rojo Conejo, Hospital 12 de Octubre
17:00 – 17:30
Closing Remarks
M. Dehlinger – Kremer EUCROF & Synteract
Attendance Fee
Early Bird Fee until 15 September 2019
• € 280 for EUCROF non-members
• € 240 for EUCROF members
After 15 September 2019
• € 330 for EUCROF non-members
• € 280 for EUCROF members
How to register?
1) Go on the REGISTRATION PAGE and click on the green "REGISTER" button
2) Check your registration and click on the green "CHECKOUT" button
3) Fill in all the necessary information and validate your registration
4) Pay the above Attendance Fee through Bank Transfer. Admittance tickets and invoice (if needed) will be sent to you as soon as we confirm the payment.
Questions?
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