ITF briefing meetings provide a forum for early dialogue on medicines innovation. They cover regulatory, technical and scientific issues arising from innovative medicines development, new technologies and borderline products – but ITF briefing meetings are intended to be much earlier than when one would normally seek scientific advice.

ITF briefing meetings facilitate informal exchange of information and guidance in the development process, complementing and reinforcing existing formal procedures such as advanced-therapy-medicinal-product (ATMP) classification and certification, designation of orphan medicinal products and scientific advice.

The objectives are two-fold: firstly, for EMA to help clarify questions regarding the road to market of innovative medicines and secondly, to help ensure EMA awareness and preparedness for assessment of the most recent developments in innovative medicine.

The informal scientific brainstorming-discussions are led by experts from the Agency network, working parties and committees.

ITF also covers the regulatory acceptance of so-called new approach methodologies (NAM) to replace the use of animals in the testing of medicines, in line with the 3Rs principles (replacement, reduction, refinement). NAMs include, for example, in silico modelling and novel in vitro assays.

This aims to encourage the development of NAMs, and to enable their integration in the development and evaluation of medicines.

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The ITF particularly invites developers to ask questions and apply for a briefing meeting to discuss NAM and treatments intended to tackle antimicrobial resistance (AMR). 

Some topics the ITF has discussed include:

• complex clinical trial methodologies;
• digital technologies (including artificial intelligence and machine learning);
• innovative manufacturing methods;
• nanotechnologies;
• pharmacogenomics;
• smart materials and synthetic biology;
• innovative methods for medicines in pregnancy and breastfeeding;
• combination products and trials;
• platform technologies for new medicines.