We will review challenges in translation required to develop the ATMPs pharmaceutical product (cell and gene therapy products) from nonclinical to the clinical stage, as well as the challenges related to the determination of proof-of-concept, how to choose clinical...

The UK will withdraw from the EU on 29 March 2019. By 1 August 2018, no agreement had been reached on a transitional arrangement to soft en the impact of Brexit. The European Commission and the European Medicines Agency (EMA) have taken a strict position on...

Project Management Plan

The purpose of this document is to define the scope of activities, outline responsibilities (define task and roles) and provide guidance on a specific project.

EUDAMED

Is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission.

Advanced therapy medicinal products (ATMPs), i.e., cell and gene therapy products, is a rapidly evolving field of therapeutic development. A significant proportion of the products are being developed by academia or small/medium-sized enterprises (SMEs).

The...

Rare diseases are characterized by a broad diversity of disorders and symptoms that vary not only from disease to disease but also from patient to patient suffering from the same disease. Rare diseases can be chronic, progressive, degenerative, and often life-threatening....

By setting mandatory requirements, paediatric regulations implemented in the EU and the US have allowed the development of – and improved access to – high-quality drugs for the paediatric population. It is acknowledged that paediatric development remains a challenge...

Consolidated Parallel Consultation

Products selected for this pathway will have an EDC composed of the EDWP members and up to 3 additional HTABs. Once the decision to proceed with a Consolidated Parallel Consultation has been taken, the EUnetHTA ED Secretariat begins the process of recruiting additional HTABs to compose the EDC.

Early Dialogues Committee (EDC)

The Early Dialogue Committee (EDC) is constituted for a specific product and the members will fluctuate to a degree for each Consultation. In the case of Consolidated Parallel Consultations, all EDWP members and a maximum of 3 other HTA members (from EUnetHTA WP5) will participate.

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