Pirkko Lepola

We call all relevant stakeholders, regulators and policy makers to foster the repurposing of medicines
for pediatric use. All potential limitations in old existing data and evidence should be balanced against
the value these data can provide to aid a widened benefit-risk assessment by regulators.

The EU Clinical Trial Regulation (2014) does not contain specific requirements exclusively for paediatric clinical trials. This work is the first to extensively collate all the current legal, regulatory and ethical documentation on the Informed Consent process, together with input from adolescents. This guide may increase the ethical standards in paediatric clinical trials.

The aim of the Paediatric Regulation (EU 1901/2006) is to improve the health of children by facilitating the development and availability of paediatric medicines. In 2017, the European Medicines Agency published a 10-year report, and concluded that a significant number of new medicines for children have been authorised. Marketing authorisation is no guarantee that a new medicine is available for all patients, as the accessibility to medicines varies across countries. Despite the intentions of… Näytä lisää

The aim of the Paediatric Regulation (EU 1901/2006) is to improve the health of children by facilitating the development and availability of paediatric medicines. In 2017, the European Medicines Agency published a 10-year report, and concluded that a significant number of new medicines for children have been authorised. Marketing authorisation is no guarantee that a new medicine is available for all patients, as the accessibility to medicines varies across countries. Despite the intentions of the EU’s Paediatric Regulation, medicines targeted at children are not all marketed, risking limitations in availability and accessibility for patients. Results: 21%–32% (16/76–24/76) of the new medicines initially authorised for children between 2007 and 2016 were not marketed across the four Nordic countries, and 29%–50% (16/56–28/56) of the new paediatric formulations were not marketed and a significant proportion had never been marketed. Näytä vähemmän

Over the last decade, with science and innovation evolving, industry has moved from a reactive to a proactive mode, investing in building appropriate structures and capabilities to better tackle the challenges and opportunities of pediatric drug development. Key successor factors and recommendations for Pediatric Expert Group (PEG) were identified. Pediatric structures and expert groups were shown to be important to support optimization of the development of pediatric medicines.

Authors: Estelle Naumburg ([email protected]), Anders Rane, Thomas Halvorsen, Heidi Glosli, Tine Brink Henriksen, Asgeir Haraldsson, Jaana Kallio, Pirkko Lepola. Acta Pædiatrica ISSN 0803-5253, DOI:10.1111/apa.14775.
"A NORDIC investigators network for PEDiatric MEDicines (NordicPedMed) was established between the years 2014 and 2017 with funding of a three‐year Nordic Trial Alliance project from the Nordic Council of Ministers and NordForsk. In NordicPedMed we find that it is now… Näytä lisää

Authors: Estelle Naumburg ([email protected]), Anders Rane, Thomas Halvorsen, Heidi Glosli, Tine Brink Henriksen, Asgeir Haraldsson, Jaana Kallio, Pirkko Lepola. Acta Pædiatrica ISSN 0803-5253, DOI:10.1111/apa.14775.
"A NORDIC investigators network for PEDiatric MEDicines (NordicPedMed) was established between the years 2014 and 2017 with funding of a three‐year Nordic Trial Alliance project from the Nordic Council of Ministers and NordForsk. In NordicPedMed we find that it is now time for children with other medical conditions, in addition to pediatric oncology, to become subject to a Nordic collaboration, promoting development of safe medicines in all paediatric areas. Such collaboration will give room to pursue ethical, cost/effective and conclusive clinical drug trials to address the unmet needs of evidence‐based medicines for neonates, children and young people, and a solid network for follow‐up of drug treatment. This may be achieved by collaboration between the five Nordic countries with altogether more than five million children and comparable to most European countries. The strengths of the Nordic area in a research context are many, including similar public paediatric health services, and advanced registries on health care using personal identification numbers and nationwide Healthcare Quality Registries and Governmental Registers." Näytä vähemmän

EU:n lastenlääkeasetus on luonut edellytyksiä sille, että lastenlääkevalikoima voi vastata paremmin lasten todellisia tarpeita. Tarvitsemme jatkossa kuitenkin enemmän lastenlääketutkimuksia. Ilman eri toimijoiden yhteistyötä ja toimivaa lastenlääketutkimusinfrastruktuuria se ei ole mahdollista.

Article in Finnish. Abstract also in English.

Kliinisen tutkimuksen tietoon perustuva suostumusprosessi - onko jo aika siirtyä sähköiseen suostumukseen?
LÄÄKETIETEELLINEN AIKAKAUSKIRJA DUODECIM

2018;134(5):481-7
Arja Halkoaho, Tapani Keränen, Pekka Lahdenne ja Pirkko Lepola

Enpr-EMA working group of Ethics -task

Experience of the first 7 years of the FINPEDMED (www.finpedmed.com)