Discussion
Started 10th May, 2021

The REFINE Project asks you

This discussion aims at capturing and sharing the experience and knowledge of sectors and communities, which have been using nano-enabled or nano-formulated products.
The REFINE Project:

Most recent answer

3rd Sep, 2021
Adriele Prina-Mello
Trinity College Dublin
TENTH TOPIC "Methodological needs in the quality and safety characterisation of nanotechnology-based health products: Priorities for method development and standardisation" ( ) : Have you ever used the gap analysis?

All replies (10)

10th May, 2021
Adriele Prina-Mello
Trinity College Dublin
FIRST TOPIC: Regulatory information needed for nanotech-enabled products. QUESTION: Do you think the existing guidance is sufficient for regulating nano-enabled health products?
1 Recommendation
19th May, 2021
Adriele Prina-Mello
Trinity College Dublin
SECOND TOPIC: Selection of the regulatory framework. QUESTION: Can we always clearly define the primary mode of action of nano-enabled health products?
31st May, 2021
Adriele Prina-Mello
Trinity College Dublin
THIRD TOPIC: The European definition of nanomaterial and its implication for nanotechnology-enabled health products QUESTION: Is it clear how to interpret EC definition of nanomaterial as used in medicaldevice regulation?
8th Jun, 2021
Adriele Prina-Mello
Trinity College Dublin
FOURTH TOPIC: The assessment of follow-on nanoproducts (called nanosimilars). QUESTION: Is the existing regulatory framework for assessing the equivalence of generic products sufficient for follow-on nanomedicinal products?
16th Jun, 2021
Adriele Prina-Mello
Trinity College Dublin
FIFTH TOPIC: Methods addressing regulatory information needs. QUESTION: Can existing standards provide the information needed for regulatory decision making?
21st Jun, 2021
Adriele Prina-Mello
Trinity College Dublin
SIXTH TOPIC: Terminology. QUESTION: Do we need to harmonise the terminology between the involved stakeholders?
30th Jun, 2021
Adriele Prina-Mello
Trinity College Dublin
SEVENTH TOPIC: Harmonisation of regulatory practice. QUESTION: Can we harmonise regulatory practices at international level?
6th Jul, 2021
Adriele Prina-Mello
Trinity College Dublin
EIGHTH TOPIC: Decision Support System 1/2. Have you ever used decision support systems in your daily work?
3rd Sep, 2021
Adriele Prina-Mello
Trinity College Dublin
NINTH TOPIC: Assessment of the similarities of the nanotechnology products. Are the existing tools adequate to support similarity assessment, grouping and/or read across in your sector?

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