Event Categories: EFGCP

Our Free of Charge weekly Q&A Webinars on Clinical Trials During the Corona Virus Pandemic are continuing! Quality and ethics experts respond to your questions from sponsor and site points of view. What are best practices for informed consent in CTIMPs? How can we help ensure these though Quality Management and Audit?

This workshop is organised as a follow-up to the EFGCP-EFPIA Multi-Stakeholder workshop on Paediatric Unmet Medical Needs, co-chaired by Prof. Vassal and Prof. Giaquinto and held in Amsterdam in December 2019.

Objectives
> Understand stakeholders’ perspectives and needs.

> Identify criteria to help define paediatric unmet medical needs using four conditions as case examples, which represent all possible paediatric development options: Asthma, NASH (Non-Alcoholic Steato-Hepatitis), Duchenne Muscular Dystrophy and Haemophilia.

> Inform on revision of the EU Paediatric and Orphan Regulations through workshop outputs.

Quality and ethics experts respond to your questions from sponsor and site points of view.

Delays in conducting and completing paediatric clinical trials are one of the major challenges researchers are facing when developing new medicines for children. The EMA Paediatric Action Plan has addressed this issue by commissioning a new guidance document to the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) that sets out recommendations for clinical trial preparedness focusing on factors which facilitate or hamper the conduct of trials in children. "Trial preparedness" is defined as a structured assessment of the key factors that could increase the likelihood of a smooth and timely course of a paediatric clinical trial, integrating information from multiple stakeholders on what is possible within individual studies and therefore also for the overall drug development plan within which a trial is embedded. These recommendations are moving beyond the definition of clinical trial "feasibility" to present a global determination of all aspects of a trial that need to be prepared with the active involvement and collaboration of all stakeholders. Active discussion of these aspects within all regulatory applications will also help resolving some of the hurdles faced during such interactions. In this webinar, members of the Enpr-EMA working group for this guidance will discuss these recommendations and provide some practical insights from for Industry, Research Networks and Patients, how to operationalize these ideas in practice.

Agenda & Presenters:
> Basic introduction to regulatory requirements for IDMC / Seif Eddine Amara Madi, GSK Biologicals
> Common findings relating to IDMC/DSMB during audits and inspections / Louise Mawer, Mirabilitas Ltd
> Main challenges for IDMC expert during COVID-19 / Stephen Toovey, Pegasus Medical & Scientific Services
> IDMCs/DSMBs: a short research ethics primer / Heather Sampson, University of Toronto
> Main challenge for IDMC management a sponsor perspective (TBC)
> Q&A, Discussions