FDA / EMA Common Commentary on Submitting an initial Pediatric Study Plan (iPSP) and Paediatric Investigation Plan (PIP) for the Prevention and Treatment of COVID-19

The Food and Drug Administration (FDA), in collaboration with the European Medicines Agency (EMA), provided procedural assistance to sponsors and applicants who anticipate submission of paediatric product development plans for the treatment and prevention of COVID-19. In issuing this Common Commentary, the FDA and EMA aspire to streamline administrative processes and facilitate efficient submission of

July 2nd, 2020|

EMA announcements for Trainees

The European Medicine Agency (EMA) is looking for motivated, qualified recent graduates or students on an Erasmus+ or other programme or PhD students, who are interested in gaining experience and contribute to the Agency’s work for every patient in Europe. The purpose of a traineeship at the Agency is to perform tasks that are predominantly

June 30th, 2020|

FDA guidance. Patient-focused drug development: collecting comprehensive and representative input

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 from patients and caregivers for medical product development and regulatory decision making. The first document is dedicated to Patient-focused

June 26th, 2020|

Innovative Medicines Initiative launches new Calls for proposals

The Innovative Medicines Initiative has launched IMI2 – Call 23. IMI2 – Call 23 is a standard, two-stage Call for proposals with the following topics: Returning clinical trial data to study participants within a GDPR compliant and approved framework Modelling the impact of monoclonal antibodies and vaccines on the reduction of antimicrobial resistance (part of

June 26th, 2020|

EC online stakeholder survey into the use and re-use of health data in the light of the General Data Protection Regulation

The European Medicines Agency (EMA) is preparing guidance in the form of “Questions and Answers” on the impact of EU data protection legislation on the secondary use of health data in support of the development, evaluation and supervision of medicines. Therefore, EMA would like to gather input from patients, consumers and healthcare professionals as data

June 26th, 2020|

Vacancy Announcement. Utrecht University: Tenure track Assistant Professor position in Real World Evidence

The Department of Pharmaceutical Sciences, Pharmacoepidemiology and Clinical Pharmacology of Utrecht University shared a vacancy announcement for Tenure track Assistant Professor position in Real World Evidence. The full-time position involves 70% research time and 30% teaching activities, offering a mix of responsibilities, such as: conducting research into development and evaluation of methods to generate evidence

June 26th, 2020|

FDA Approves Dupilumab For Children With Atopic Dermatitis

The U.S. Food and Drug Administration (FDA) approved Dupixent® (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent is a fully-human monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13)

June 26th, 2020|

EMA New medicine authorised: gene therapy Zolgensma for the treatment of spinal muscular atrophy

EMA has recommended granting a conditional marketing authorisation in the European Union for the gene therapy Zolgensma (onasemnogene abeparvovec) to treat babies and young children with spinal muscular atrophy (SMA), a rare and often fatal genetic disease that causes muscle weakness and progressive loss of movement. Spinal muscular atrophy is usually diagnosed in the first

June 26th, 2020|

TEDDY Publication. Ethical, legal and regulatory issues of paediatric translational research call for an adequate model of governance. European Journal of Health Law. May 2020.

We are pleased to inform you that the article “Ethical, Legal and Regulatory Issues of Paediatric Translational Research. Call for an Adequate Model of Governance” has been published on the European Journal of Health Law. The authors, Annagrazia Altavilla, Viviana Giannuzzi, Mariangela Lupo, Donato Bonifazi and Adriana Ceci, after having clarified the concept of translational

June 26th, 2020|

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 potentially be used in the paediatric population, have not been studied in the relevant paediatric age

June 26th, 2020|