REFINE Second Knowledge Exchange Conference

KEC2 Booklet

“REFINE project aims at setting up a Regulatory Science Framework (RSF) for the risk-benefit assessment of NBM-based medicinal products and medical devices.
In this context, the second Knowledge Exchange Conference (KEC) focused on building solutions for knowledge sharing on regulatory challenges in Nanotechnology and sharing the experience and knowledge on regulatory challenges and solutions of different sectors and communities, which have been using nano-enabled or nano-formulated products.”

The Booklet where the messages of the KEC2 are summarised is now available.

KEC2 Booklet

Session 1: Regulatory challenges for nanotechnology-based products across different sectors

Regulatory challenges for nanotechnology-based products in different sectors including health, food, cosmetics and industrial chemicals, were identified in the REFINE White Paper and during the Gov4nano transregulatory risk assessorssummit. The regulatory questions are related to different aspects of the regulatory assessment and include e.g. critical parameters to determine equivalence/similarity of different nanotechnology products, availability of test methods, harmonisation of regulatory practice, terminology and definition. The goal of the session is to identify those challenges that are common for many sectors. The interaction with participants should help to identify most critical regulatory questions, translate them into research questions, and prioritize the research activities that could be initiated in a common cross-sectorial effort.

Chair: Susanne Bremer-Hoffmann

Moderator: Blanka Halamoda-Kenzaoui

Speakers: Adrienne Sips; Phil Sayre

Session 2: Decision support tools addressing the challenges related to the use of nano(bio)materials under different regulatory frameworks

This session discusses the variety of aspects that need to be considered and assessed when designing sustainable nano(bio)materials-enabled products to be used in different sectors and how decision support systems can integrate the huge amount of information with the aim of supporting developers and decision makers in selecting the most effective solutions/alternatives. The workshop is giving the participants a brief overview of the existing and developing DSSs for nano(bio)materials used across different sectors, their aims and their characteristics and usability so that they identify which ones may be suitable for their real life decisional problems.

Chair: Lisa Pizzol

Moderator: Robert Geertsma

Speakers: Alex Zabeo

Session 3: Assessment of the similarities of nanotechnology products

The session aims to provide an overview of the current approaches for assessment of similarity between nanoforms as developed in several EU projects and industry-led initiatives. The session will cover both the engineered nanomaterials used in consumer products and medical applications. In addition, the presentations and the discussion will address the related topics of grouping and read-across. The session will start with a presentation of the framework for grouping of nanomaterials developed in the EU Horizon 2020 GRACIOUS project. This will be followed by an overview of the existing approaches for similarity assessment and grouping of nanoforms form both industrial and regulatory perspectives. There will be a special focus on the topic of biosimilars/nanosimilars in the field of nanomedicine.

Chair: Hubert Rauscher

Moderator: Danail Hristozov

Speakers: Vicki Stone;  Wendel Wohlleben; Mario Pink; Gerrit Borchard.