EMA Aims to Give New Impetus to Pediatric Trials
The Pediatric Committee (PDCO) of the European Medicines Agency (EMA) has revised the current list of class waivers for medicines that are not required to submit a pediatric investigation plan.
The Pediatric Committee (PDCO) of the European Medicines Agency (EMA) has revised the current list of class waivers for medicines that are not required to submit a pediatric investigation plan (PIP).
These are the most extensive revisions to date, and are designed to better balance the need to support development of medicines in children with the goal of avoiding exposing children to unnecessary studies, according to a statement from EMA. It hopes the revisions will encourage companies to develop more new medicines for use in children.
The revisions follow the PDCO’s review of the experience with class waivers since the Pediatric Regulation came into force in 2007. It noted that most of the class waivers refer only to medicines targeting specific diseases, and this may mean the potential for the use of the medicines in children more generally is not explored. The PDCO concluded that the current class waiver list resulted in insufficient opportunities for the committee to consider the potential benefits of some new medicines for children.
As a result, the PDCO has assessed, for all class waivers, the available information on the disease area, the characteristics of the medicines and any available evidence on their possible use in children. It has revoked eight class waivers, updated 15 class waivers and confirmed nine class waivers in the current class waiver list.
Companies developing medicines, which are not covered by the revised list of class waivers, will need to submit a request for a PIP or a product-specific waiver, for scientific review and agreement by the PDCO.
In future, more medicines will be reviewed by the PDCO for potential development for use in children, and the PDCO will continue to revise the class waiver list as more information becomes available, according to the EMA.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
