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Paeditric medications in 2024, availability and perspectives
Sylvie Benchetrit, PharmD PhD – French medicine Agency
She has been elected as Vice-Chair of the Paediatric Committee (PDCO) in 2022, at the European Medicines Agency (EMA).
She is acting as the French Delegate PDCO since 2010.
Sylvie Benchetrit is the Paediatric Referent of the French medicine agency (“Agence nationale de sécurité du médicament et des produits de santé”, ANSM), within the European and Innovation department. She is co-chairing the expert paediatric group of health care professionals and patient representatives at the ANSM.
Senior assessor of the Paediatric Investigation Plans (PIPs) and expert on the paediatric scientific and regulatory recommendations at European and French levels, she has been participating since the beginning of the European Paediatric Regulation (in 2007) on paediatric topics and scientific advisory for paediatric medicines.
Before ANSM, she has worked in industry, public entities and non-profit organizations.
She is a pharmacist (PharmD PhD) with an expertise on epidemiology (Master of Research).
Fabienne Benoist, PhD – Head of Regulatory Sciences at Drugs for Neglected Diseases initiatives (DNDi)
Fabienne Benoist joined DNDi in October 2020 as Head of Regulatory Sciences. She is leading DNDi‘s Regulatory Sciences team, supporting all DNDi programmes and associated regulatory activities. She has 24 years of experience in Regulatory Affairs/Sciences in providing global regulatory direction through all stages of research and development for worldwide access to medicines.
Having worked for Non-Government Organisations (NGOs) in Africa and Asia and by working in the field of tropical /infectious diseases development for 14 years, Fabienne has in-depth expertise about the research and development of drugs and strong knowledge of the regulation of neglected diseases in Low and Middle Income countries. She has also developed a considerable experience by collaborating with private and public sectors for regulatory policy and advocacy, in particular with global health regulatory authorities, WHO, international associations (IFPMA, EFPIA…) and different international key stakeholders (Bill Melinda Gate foundation (BMGF), World Bank, African Union, EUropean and Developing Countries Clinical Trial Partnerships (EDCTP).
Prior to joining DNDi, Fabienne worked at Novartis.
Fabienne holds a PhD in cell and molecular biology form the Pierre and Marie Curie University, Paris and a master in public heath at the London School of Hygiene and Tropical Medicines.
Céline Chu, PharmD PhD – European Medecines Agency
Céline Chu is Clinical assessor of the Paediatric Investigation Plans (PIPs) for Paediatric Committee (PDCO) of European Medicines Agency (EMA). She is responsible for the coordination of paediatric projects and acting as paediatric assessor at ANSM. She is co-sharing the expert paediatric group of health care professionals and patient representatives at the ANSM.
At European and French levels, she has been assessing marketing authorizations request in centralized, decentralized, mutual recognitions and national procedures between 2015 and 2022.
Before ANSM, she was a hospital pharmacist for ten years.
She is a pharmacist (PharmD PhD).
Anne-Laure Clairet, PhD – CHU Besançon
Hospital pharmacist in the University of Besançon:
Clinical pharmacist: in the oncology and paediatrics departments, ensuring patient care pathways, Drug management in clinical trials, Outpatiend drug dispensing
Associate Professor in the UFR “Sciences de la Santé de Besançon” University of Franche-Comté
Clinical pharmacy course of the Faculty of Pharmacy and for pharmacy technicians, Simulation-based teaching
PhD thesis about Managing medication risks in specific contexts: typology and epidemiology
Audrey Jeanjean, PhD – Pharmaceutical Development Section Head, SANOFI
Audrey Jeanjean serves as a Project Manager at Sanofi Aventis R&D in Montpellier, specializing in galenics with a focus on pharmaceutical development. She possesses technical expertise in the formulation and development of solid oral dosage forms, such as chewable tablets and minitablets, tailored for both geriatric and pediatric patients.
Prior to her role in pharmaceutical development, Audrey managed research projects in the fields of medicinal chemistry, polymer science, and drug delivery systems.
She has a PhD in medicinal chemistry and holds a master’s degree in polymers for therapeutic applications.
Carlos Javier Parramon Teixido, Hospital pharmacist – Vall d’Hebron Barcelona Hospital Campus
I am a Hospital Pharmacist and I work at the Pharmacy Service of Vall d’Hebron Campus Hospital. I manage medication and provide pharmaceutical care focused on the safe use of medications, preparing medications for individualized treatments for both inpatients and outpatients. I belong to the Basic, Translational, and Clinical Pharmacy research group at Vall Hebron Research Institute, which primarily focuses on personalized medicine. I am involved in pediatrics, particularly in Neonatology, and in preparing both sterile and non-sterile medications for pediatric patients. Regarding medication preparation, I am pursuing a Ph.D. at the University of Santiago de Compostela on 3D printing of medications for pediatrics in the hospital setting.
Prof. Sonia Prot-Labarthe (Pharm D, PhD) – Nantes University
I am a pharmacist and clinical pharmacy at Nantes University, France. After completing a pharmacy residency in France, I worked for 5 years at CHU Sainte Justine in Montreal, Quebec, where I completed a specialized residency in pediatric pharmaceutical care. She then worked for 12 years at Robert-Debré Hospital (AP-HP, French mother-child hospital in Paris). Since 2020, I am a professor of clinical pharmacy in Nantes. Active member of the SFPC Board, I coordinate the SFPC’s pediatric working group. I also participate in the ANSM (Agence nationale de sécurité du médicament et des produits de santé) pediatric group. I am editor-in-chief of Pharmacien Clinicien.
Nicolas Rollet, Ph.D – Head of Formulation & Analytical expert, Adexpharma
I have 15 years of experience in R&D, and I presently has a position of Head of Formulation and Analytical Expert at AdhexPharma. By training, I have got my PhD within CNRS in the Institut de Chimie Moléculaire from University of Burgundy (ICMUB). In the first 10 years, my activities were particularly focused on the development of analytical methods for specific galenic formulation (topical forms such as transdermal patches, thin films, semi-solid forms, …), cosmetics and medical devices (implants, …), along with the management of scientific teams and laboratories. In the past 5 years, I have been started other scientific activities, especially focused on formulation and conception of new drug product design and delivery systems such as transdermal patches and thin films. I have also been implemented the R&D activities during my several leadership positions, and I have been committed to the development of academia-industry relationships. I get co-inventor of patents about new identification technology and innovative manufacturing technologies. Plus, I am managing a PhD thesis in collaboration with the Department of Pharmacy at the University of Burgundy.
Prof. Joseph Standing – Great Ormond Street Institute of Child Health, University College London
Prof. Standing is an academic and hospital pharmacist who holds a PhD in clinical pharmacology, and MSc in Statistics. Prior to becoming a professor he held two UK Medical Research Council academic fellowships (Methodology 2011-2015, Clinician Scientist 2015-2020) which led to the development of a paediatric pharmacometrics research group at the UCL Great Ormond Street Institute of Child Health. The main research interests of the group are in undertaking clinical and pre-clinical pharmacokinetic-pharmacodynamic (PKPD) with the aim to improve the evidence base of medicines for children. Therapeutic areas include infectious diseases, oncology, critical care and neurology. The group is funded from research council and European agencies, charities/non-profit, and pharmaceutical industry collaborations. In addition Prof Standing Leads a MSc module and short-course entitled “Pharmacometrics”, where students gain theoretical and practical computational knowledge on population PKPD.
Catherine TULEU, PhD – Professor in Paediatric Pharmaceutics at UCL School of Pharmacy, UK. (https://orcid.org/0000-0001-8384-357X ; H-index 31)
Her research, inherently translational, ranges from formulation, methodology development to clinical implementation, integrating the following themes: children centric excipient research; repurposing by reformulating for better medicines for children; development of innovative age appropriate dosage forms (especially for under 5s); administration issues and devices and sensory pharmaceuticsTM (dosage form acceptability and in vitro/in vivo taste assessment).
https://www.ucl.ac.uk/pharmacy/people/professor-catherine-tuleu
Her spin out company senCeuTics Ltd. specializes in pharmaceutical sensory evaluation and offers a full spectrum of preclinical, clinical and paediatric formulation services under one roof.
https://senceutics.com/
She is the founder and chairperson of the European Paediatric Formulation Initiative (EuPFI), a consortium working in a pre-competitive way on paediatric drug formulations.
http://www.eupfi.org/
https://www.linkedin.com/in/catherine-tuleu-9b842214/
Caroline Viault, PharmD PhD – Pharmaceutical Development section Head – SANOFI
Caroline Viault is a Senior Galenic Manager with extensive experience in pharmaceutical development. Currently, she leads a Drug Product Development team at Sanofi Aventis R&D, Montpellier. Her technical competencies include formulation and development of various pharmaceutical forms, such as immediate or modified-release oral dry forms, buccal and sublingual forms (tablets, films), orodispersible tablets, implants, and mini-tablets. Her expertise extends to the production of clinical batches, scale-up, validation, and launch. She has experience in various technologies such as fluidized air bed coating, classic or perforated turbine, wet and dry granulation, mixing, compression, encapsulation, nanomilling, and solvent casting.
For group registration, please contact Laurence: apgi@apgi.org
