Traduction de «Identifier les risques de sécurité des TIC » (Français → Anglais) :

12. Proposes that, in order to meet the EU 2020 strategy objectives, research supported by FP7 be focussed towards addressing EU’s most pressing challenges within the sectors identified in the ‘Cooperation’ chapter of FP7: health (including clinical and preventive research and medical technologies), food and biotechnology (including food safety), ICT, nanosciences and nanotechnologies, energy (including energy efficiency, smart grids, renewable energy, CCS, the SET-PLAN and the use of biogas), environment (including climate change, water, soil, woods and forests), sustainable transport, socio-economic sciences and humanities, ...[+++]space and security;

The directive introduces obligatory safety features for all prescriptive medicinal products and a rapid alert system; harmonised safety features to verify authenticity and identify individual packs, providing tampering evidence for medicinal products subject to prescription (possible exclusion of certain products following a risk assessment); no safety features for medicinal products not subject to prescription, unless a risk assessment demonstrates the risk of falsification and consequently a threat to public health; traceability: there will be a unique identifier for the safety features (e.g. a serialisation number) which allows the ...[+++] authenticity of the product and individual packs to be verified throughout the supply chain up to pharmacy level; in addition, Member States have to set up systems to prevent suspected medicinal products from reaching patients; Internet sales: conditions for the supply of medicinal products to the public are determined by Member States; increased transparency as regards wholesale distributors; penalties applicable to infringements of national provisions must be applied.

‘15. Post-authorisation safety study: Any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures’.

To do that, in Europe we need to identify the safety concerns, collect data for a health and environmental impact assessment of the product, and act at the earliest possible stage through adjustments, where necessary, of risk assessment procedures for nanotechnology.

Post-authorisation safety study : Any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures.

General information includes strategic and tactical information designed to inform event preparations and operations in respect of identifying and preventing or reducing safety and security risks, undertaking pre-event and ongoing dynamic risk analyses, and responding appropriately and proportionately to safety and security risks as they emerge during the event.