Drug/Device and Device/Drug Combinations in the EU and USA

Apr 20th, 2016Apr 21st, 2016

London, 17

GB

http://management-forum.co.uk/product/details/2035

Phone:+44 (0) 20 7749 4730

This seminar will provide practical advice on the borderline issues concerning these combination products and provide key guidance on the regulatory strategy to follow.

Emphysema progression with hole changes, with holes colored according to their diameter in 2-mm increments. (A) Baseline inspiratory nonenhanced axial CT scans in a 48-year-old man with chronic obstructive pulmonary disease show emphysema holes with hyperexpansion of secondary pulmonary lobules (white arrows) and thin alveolar walls visible in the right upper lobe. This emphysematous lesion is filled with holes of varying sizes. A single large air cyst was observed in the left upper lobe (black arrows), classified as a single emphysema hole of 20 mm or greater (bright green). (B) At six-year follow-up inspiratory nonenhanced axial CT, the holes in the right upper lobe have merged (white arrows), with no visible alveolar septa remaining, resulting in the formation of a large new hole of 20 mm or greater (bright green). Meanwhile, the hole in the left upper lobe also enlarged, merging with adjacent holes (black arrows). The size of other holes in the paramedian left upper lobe decreased.

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Emphysema progression with hole changes, with holes colored according to their diameter in 2-mm increments. (A) Baseline inspiratory nonenhanced axial CT scans in a 48-year-old man with chronic obstructive pulmonary disease show emphysema holes with hyperexpansion of secondary pulmonary lobules (white arrows) and thin alveolar walls visible in the right upper lobe. This emphysematous lesion is filled with holes of varying sizes. A single large air cyst was observed in the left upper lobe (black arrows), classified as a single emphysema hole of 20 mm or greater (bright green). (B) At six-year follow-up inspiratory nonenhanced axial CT, the holes in the right upper lobe have merged (white arrows), with no visible alveolar septa remaining, resulting in the formation of a large new hole of 20 mm or greater (bright green). Meanwhile, the hole in the left upper lobe also enlarged, merging with adjacent holes (black arrows). The size of other holes in the paramedian left upper lobe decreased.

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Pelvic (A), femoral and popliteal (B), and cruro-pedal (C) region. The summated digital variance angiography (DVA) image significantly enhances image quality compared to the digital subtraction angiography (DSA) series I–IV (depicting 4 out of 28 (A), 48 (B) and 28 (C) DSA images) of the low dose (LD) acquisitions. Enhancements of iodinated contrast medium (ICM) by DVA depict small vessel structures in detail while the conventional DSA offers a reduced contrast-to-noise ratio (CNR) using LD acquisitions for standalone diagnostic interpretations.

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