Webinar EuroGTP II methodologies and tools

Good practices for evaluating quality, safety and efficacy of novel tissue and cellular therapies and products - EuroGTP II methodologies and tools


Course type

Basic

 

Course description

Advances in basic science, technology and medicine continually create opportunities for new and improved medically assisted reproduction (MAR) therapies.
These may be wholly new types of therapies or improved methodologies for the preparation of existing techniques. While the objective of these changes and novelties is to prepare MAR therapies that are safer, clinically more effective and meet the needs of clinicians and patients, there is always a risk that any change in the processing method can result in harm in the recipient. It is therefore vital that an evaluation of the potential risk of a process is systematically evaluated whenever a significant change is made

The aim of this training webinar is to aid cell and tissue bankers and healthcare professionals in the evaluation of safety, quality and efficacy of MAR therapies, thus providing effective care of their patients.

 

Learning objectives

The generic objectives of this course are:

  • To promote good practices for the correct implementation of novel Tissue and Cells Therapies and Products (TCTP).
  • Provide insight regarding the rationale behind EuroGTP II’s methodologies.
  • Support the appropriate use of tools and methodologies provided by the EuroGTP II project, and the correct interpretation of its outcomes.

 

Target audience

The targets of this training are:

  • Tissue establishment (TE) professionals: operational staff, scientists and embryologist developing MAR therapies, quality control personnel.
  • Health care professionals: namely the end users of novel MAR.

 

Educational needs and expected outcomes

The course aims to improve the scientific assessment of novel products/processes/clinical indications and associated risks, and promote the correct definition of evaluation protocols to guarantee safe implementation

By the end of this training participants should be able:

  • Correctly assess the novelty of a MAR therapy.
  • Understand the different risk factors and risk consequences associated with the TE’s activities and clinical application of Substances of Human Origin.
  • Perform objective risk analysis based on the rationale proposed by EuroGTP II – by evaluating the risks resulting from all aspects of T&C supply chain (from donor selection to clinical application) of the final product.
  • Design appropriate studies proportionate to the level of residual/unknown risk to confirm that the novel MAR therapy is safe and effective.

 

Programme

11:00 – 11:20 Introduction to EuroGTP methodologies - Ioana Rugescu
11:20 – 12:00 Practical cases - Kelly Tilleman
12:00 – 12:20 Discussion - Inputs from participants and Q&A – Moderator: Jaime Tabera & Richard Lomas
12:20 – 12:30 Impact and continuity of EuroGTP II Project – Rita Piteira