Food and Drug Administration (FDA) is developing four guidance documents to address, in a stepwise manner, how stakeholders (patients, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information...
Pharmaceuticals – safe and affordable medicines (new EU strategy)
The European Commission is launching a new strategy to improve and accelerate patients’ access to safe and affordable medicines and to support innovation in the EU pharmaceutical industry, addressing mainly: the life cycle of medicines from R&D to authorisation...
TEDDY WG on health data. Revision and analysis of Post-Authorisation studies in paediatric population included in the EU PAS Register
Data collection in healthcare allows health systems to create holistic views of patients, personalize treatments, advance treatment methods, improve communication between doctors and patients, and enhance health outcomes. For this reason, the promotion of data...
TEDDY WG on off-label use. Updating of list of medicines used off label in children
The European Medicines Agency defines “off-label” the use of a medicine for an unapproved indication or in an unapproved age group, dosage, or route of administration. The majority of marketed medicines world‐wide, including those commonly used or which could...
Paediatric Devices survey. Your help is needed! Share your experiences of using devices to take medicines
The European Paediatric Formulation Initiative (EuPFI) works to improve the preparation of better and safer medicines for children. One area they are interested in is the “gadgets” or devices (e.g. measuring spoons, dosing cups, inhalers) that are used to help...
COVID-19 CLINICAL RESEARCH FLYERS
The Multi-regional Clinical Trials Center of Brigham (MRCT) in collaboration with Harvard Catalyst have developed a series of COVID-19 clinical research handouts that can be used as general informative material to prepare potential participants in advance of...
FDA requests Input on the Establishment of a Rare Disease Clinical Trial Network
The Food and Drug Administration has announced the launch of a docket to require inputs and comments from patients, patient advocates, the scientific community, health professionals, regulatory and health authorities and general public regarding practical steps to...
EPTRI AT THE ECDR 2020 MEETING
On May 14-16th over 1,500 people from 57 different countries, representing all stakeholder groups in the rare disease community, joined together at the 10th European Conference of Rare Diseases & Orphan Products — ECRD 2020. EPTRI, an EU-funded project coordinated...
International Clinical Trials Day 2020
International Clinical Trials Day is held on 20 May each year since 2005 to commemorate the day that James Lind began his famous trial for the scurvy. The objective is to make this moment a focal point for international communication events, meetings, debates, and...
DH-BIO Statement on human rights considerations relevant to the COVID-19 pandemic
The Committee on Bioethics (DH-BIO) - Council of Europe released “DH-BIO Statement on human rights considerations relevant to the COVID-19 pandemic”, recalling the fundamental principles, based on the respect for human dignity and human rights, which must guide...