%PDF-1.3 1 0 obj << /Type /Catalog /Outlines 2 0 R /Pages 3 0 R >> endobj 2 0 obj << /Type /Outlines /Count 0 >> endobj 3 0 obj << /Type /Pages /Kids [6 0 R 31 0 R 35 0 R 38 0 R 43 0 R 46 0 R 49 0 R 52 0 R 82 0 R ] /Count 9 /Resources << /ProcSet 4 0 R /Font << /F1 8 0 R /F2 9 0 R /F3 10 0 R /F4 11 0 R /F5 33 0 R >> /XObject << /I1 12 0 R /I2 13 0 R /I3 18 0 R /I4 25 0 R /I5 30 0 R /I6 34 0 R /I7 37 0 R /I8 42 0 R /I9 45 0 R /I10 48 0 R /I11 51 0 R >> >> /MediaBox [0.000 0.000 595.280 841.890] >> endobj 4 0 obj [/PDF /Text /ImageC ] endobj 5 0 obj << /Creator (DOMPDF) /CreationDate (D:20220607114222-04'00') /ModDate (D:20220607114222-04'00') /Title (Placing Patient Safety First: Developing A Disaster Plan To Reduce Risks From Covid-19 Stability Program Impacts) >> endobj 6 0 obj << /Type /Page /Parent 3 0 R /Annots [ 14 0 R 16 0 R 19 0 R 21 0 R 23 0 R 26 0 R 28 0 R ] /Contents 7 0 R >> endobj 7 0 obj << /Length 4141 >> stream 1.000 1.000 1.000 rg 34.016 34.016 527.249 773.859 re f q 441.000 0 0 97.500 45.016 710.374 cm /I2 Do Q 0.000 0.000 0.000 rg BT 45.016 699.385 Td /F1 9.0 Tf [(Published on )] TJ ET BT 99.547 699.385 Td /F2 9.0 Tf [(IVT Network)] TJ ET BT 149.056 699.385 Td /F1 9.0 Tf [( \()] TJ ET BT 154.555 699.385 Td /F1 9.0 Tf [(http://www.ivtnetwork.com)] TJ ET 0.000 0.000 0.000 RG 0.18 w 0 J [ ] 0 d 154.555 698.234 m 259.081 698.234 l S BT 259.081 699.385 Td /F1 9.0 Tf [(\))] TJ ET 0.620 0.620 0.620 rg 45.016 686.888 506.159 0.750 re f 0.000 0.000 0.000 rg BT 45.016 662.142 Td /F3 15.0 Tf [(Placing Patient Safety First: Developing A Disaster Plan To Reduce Risks From )] TJ ET BT 45.016 644.329 Td /F3 15.0 Tf [(Covid-19 Stability Program Impacts)] TJ ET q 45.016 537.248 506.159 88.973 re W n 0.800 0.800 0.800 rg 45.016 625.845 13.005 0.750 re f 0.000 0.000 0.000 rg BT 45.016 577.613 Td /F1 9.0 Tf [(By)] TJ ET 0.800 0.800 0.800 rg 58.021 625.845 67.005 0.750 re f q 23.250 0 0 31.500 61.771 594.720 cm /I3 Do Q 0.000 0.000 0.000 rg BT 125.026 615.231 Td /F4 9.0 Tf [(Kim Huynh-Ba)] TJ ET BT 125.026 576.231 Td /F1 9.0 Tf [(, )] TJ ET 0.800 0.800 0.800 rg 125.026 625.845 72.027 0.750 re f q 25.500 0 0 31.500 128.776 582.227 cm /I4 Do Q 0.000 0.000 0.000 rg BT 197.053 602.738 Td /F4 9.0 Tf [(Laure L. Larkin)] TJ ET 0.800 0.800 0.800 rg 197.053 625.845 112.041 0.750 re f 0.000 0.000 0.000 rg BT 197.053 579.488 Td /F4 9.0 Tf [(Aug 26, 2020 2:21 pm EDT)] TJ ET Q BT 45.016 422.361 Td /F4 10.5 Tf [(ABSTRACT)] TJ ET BT 45.016 397.628 Td /F1 9.0 Tf [(Scientists and regulators have warned the industry about the importance of creating a Disaster Plan for over three decades. )] TJ ET BT 45.016 383.891 Td /F1 9.0 Tf [(We have experienced industry disruptive weather events like Hurricanes Katrina and Maria, geological events including )] TJ ET BT 45.016 370.155 Td /F1 9.0 Tf [(Fukushima, industrial accidents like Deep Water Horizon and Chernobyl, and now a global pandemic like COVID-19. Still, too )] TJ ET BT 45.016 356.419 Td /F1 9.0 Tf [(many healthcare companies are taken by surprise and are unprepared for the disruption to the critical Stability Program, thus )] TJ ET BT 45.016 342.683 Td /F1 9.0 Tf [(significantly increasing impacts on the product expiry, as well as other risks. The question urgently at hand is: Can you shut )] TJ ET BT 45.016 328.946 Td /F1 9.0 Tf [(down your operations and reopen unchanged after the pandemic? [1])] TJ ET BT 45.016 304.680 Td /F1 9.0 Tf [(Without a pre-approved stability- specific Disaster Risk Reduction \(DRR\) Plan, organizations are simultaneously forced into )] TJ ET BT 45.016 290.944 Td /F1 9.0 Tf [(significant patient safety, efficacy, and regulatory exposure when samples suddenly cannot be pulled or tested to fulfill the )] TJ ET BT 45.016 277.208 Td /F1 9.0 Tf [(stability commitments. This type of impact occurred on March 23, 2020, when India implemented a country-wide 21-day )] TJ ET BT 45.016 263.471 Td /F1 9.0 Tf [(lockdown due to the COVID-19 Pandemic with a 4-hour notice. As noted by Langerman and Elson, It is easier to turn off )] TJ ET BT 45.016 249.735 Td /F1 9.0 Tf [(something than it is to start it up again.[2])] TJ ET BT 45.016 225.469 Td /F1 9.0 Tf [(This discussion will guide readers through the process of creating a DRR Plan for the stability program that will be both robust )] TJ ET BT 45.016 211.733 Td /F1 9.0 Tf [(enough to cover all the major disaster types and flexible enough to adjust for externalities. Additionally, risk mitigation )] TJ ET BT 45.016 197.996 Td /F1 9.0 Tf [(approaches will be discussed, along with regulatory exposures to consider. Without a Stability DRR Plan, organizations will )] TJ ET BT 45.016 184.260 Td /F1 9.0 Tf [(struggle with protecting patient safety and efficacy while recovering business continuity from any disruptions such as COVID-)] TJ ET BT 45.016 170.524 Td /F1 9.0 Tf [(19.)] TJ ET BT 45.016 144.389 Td /F4 10.5 Tf [(INTRODUCTION)] TJ ET 0.890 0.929 0.737 RG 1.5 w 0 J [ ] 0 d 64.516 453.998 147.750 75.000 re S q 146.250 0 0 73.500 65.266 454.748 cm /I5 Do Q endstream endobj 8 0 obj << /Type /Font /Subtype /Type1 /Name /F1 /BaseFont /Helvetica /Encoding /WinAnsiEncoding >> endobj 9 0 obj << /Type /Font /Subtype /Type1 /Name /F2 /BaseFont /Helvetica-Oblique /Encoding /WinAnsiEncoding >> endobj 10 0 obj << /Type /Font /Subtype /Type1 /Name /F3 /BaseFont /Times-Roman /Encoding /WinAnsiEncoding >> endobj 11 0 obj << /Type /Font /Subtype /Type1 /Name /F4 /BaseFont /Helvetica-Bold /Encoding /WinAnsiEncoding >> endobj 12 0 obj << /Type /XObject /Subtype /Image /Width 588 /Height 130 /Filter /FlateDecode /DecodeParms << /Predictor 15 /Colors 1 /Columns 588 /BitsPerComponent 8>> /ColorSpace /DeviceGray /BitsPerComponent 8 /Length 8715>> stream x]OK#MDA+x !\K ބ {o/|ygz&Y}Nt]]]UyD~|VVd`蓨CFAgy~u2W!Bm}u%2gSFDK_]惂la蓨-L}U)ϢKݯDFsA0_]恊W"+ Sk<`k
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