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Mosco w , 12 September 2013

Mosco w , 12 September 2013. OUR AMBITION is to compete with top tier global depots that operate in Russia and to bring clinical trial logistics services to a new quality and business culture levels.

christian-kennedy
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Mosco w , 12 September 2013

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  1. Moscow, 12 September 2013

  2. OUR AMBITION is to compete with top tier global depots that operate in Russia and to bring clinical trial logistics services to a new quality and business culture levels. • COREX is a state-of-the-art, audit-ready, GDP and GSP-compliant pharmaceutical depot for study drugs and clinical trial materials located in Moscow, Russia. • COREX was designed and built to fully comply with both local and international industry standards.

  3. WHY COREX? • team of thoroughly trained and experienced professionals • intricate knowledge of pharmaceutical logistics • full range of depot services • storage in all temperature conditions, including -40-70C and LN2 • unparalleled expertise in customs clearance and procurement of required permits and licenses

  4. OURLOCATION COREXisstrategicallysituatedbetween Vnukovo(VKO)and Domodedovo (DME)airports(major domestichubs) enablingfastand relievabledeliveryto clinicalsitesthroughoutRussia.

  5. OUR SERVICES • extension labeling/relabeling • destruction of study materials • pharmacovigilance • organization of named patient program • temperature controlled distribution • temperature controlled storage • local procurement of study drugs and clinical trial materials • regulatory support and customs clearance

  6. TEMPERATURECONTROLLEDSTORAGE • 5 main temperature-controlled zones: • ambient: 15°C-25°C • refrigerated: 2°C-8°C • frozen: -40°C • deep frozen: -80°C • LN2: -196°C

  7. TEMPERATURECONTROLLEDDISTRIBUTION • guaranteed on-time distribution of medical products and study supplies • use of validated cold chain shippers • controlled ambient, +2/+8°C and dry-ice shipments • T° monitoring during transportation by validated temperatureloggers (TT4,Libero, etc.) • hand-to-hand delivery

  8. LOCAL PROCUREMENT OF STUDY DRUGSAND CLINICAL TRIAL MATERIALS • licensed wholesaler of pharmaceuticals, rare and controlled medicines, specialized products • branded and generic drugs • a single batch number within necessary timelines • long shelf lives • certificates of analysis/conformance • direct contracts and preferred provider statuses with pharmaceutical companies and suppliers • exclusively for clinical trials • full compliance with local regulatory sourcing requirements • updates on product availability and advance ordering • timely and safe delivery

  9. COREXholdsanactiveunrestrictedRussianpharmaceutical license

  10. REGULATORY SUPPORT AND CUSTOMSCLEARANCE • real-time interface with Electronic Declaration Centre ensures uninterrupted submissions of customs declarations • average lead time for standard clearance is 3 business days • expedited clearance never exceeds 2 businessdays • preparation and submission of the dossier for official approval of importation of the drug or CTM  • procurement of Import and Export Licenses within 10 days • procurement of Certificates of Conformity • shipment preparation and negotiations with the consignor 

  11. EXTENSION LABELING/RELABELING • full compliance with GMP: • extension labeling • study specific labeling • just-in-time labeling • comparator drug re-labeling • “for clinical trial use only”

  12. DESTRUCTION OF STUDY MATERIALS • full compliance with Federal Law 61-FZ on Circulation of Medicines • receipt and reconciliation of unused or expired study materials from trial sites  • pre-destruction storage • safe transportation to a certified destruction facility • generation and submission of the Destruction Certificate

  13. PHARMACOVIGILANCE • experienced staff trained in medical monitoring, verification and detection of signals (CIOMS IV and VIII) • intricate knowledge of local regulatory requirements • reliable quality assurance system • seminars and workshops on pharmacovigilance, consultations and training • 24/7 quality control assistance

  14. AUDITS AND INSPECTIONS HISTORY • inspections: • Roszdravnadzor(21-22 August 2012) • audits: • 1 customer GMP audit (23 April 2012) • 1 customer GDP audit (25 January) • 2013 – 18 customers documental audits

  15. INVENTORYMANAGEMENT SOFTWARE (IMS) • COREX' Inventory Management System, • in concert with 3PL Central • state-of-the-art, cloud based solution • direct access to real time inventory and shipment information

  16. IMS: WAREHOUSE MANAGEMENT • receipt/shipment registration • inventory management by lot number, serial number, and/or expiration date • allocated zonal storage management • full kitting and assembly functions • regulatory document tracking • investigational site data-basing

  17. IMS: REPORTING and STATUS UPDATES • automatic customers notifications via email of key warehouse events(e.g., receipts, shipments, etc.) • temperature / humidity excursion SMS-notification • expiry date notification • online access to  real-time inventory status, shipment status, parcel tracking information • integrated management reporting • transparent financial reporting

  18. IMS: EMERGENT FEATURES • online zonal temperature tracking • mobile barcode scanning • integration with the courier services

  19. DEPOTLAYOT BY ZONES Totalwarehousespaceis750squaremetersoffloor space Additional750m2areavailableifrequired

  20. MAPPING • two steps of validation – summer period (June 2012) and winter period (February 2013) • COREX performed validation of the facility by the renowned international measuring provider – Testo, AG – results confirmed that actual facility parameters met planned parameters

  21. EQUIPMENT • certified, calibrated and validated • latest active temperature control system with a unique ventilation circuit • +2 - +8C walk-in chambers • -20 - -40C and -40 - -70 freezers • temperature monitoring system with GSM alarm messaging • access control & 24/7 security with video surveillance • fire prevention and alarm system • back-up power generator covering all depot systems

  22. SAFETY • 24/7 security of the precinct • 24/7 security of the building (licensed security agency) • video monitoring of working areas • electronic keys access to main storage areas • security and fire alarm systems • proximity to a police station

  23. ORGANIZATIONAL CHART

  24. CONTACTS For inquiries in Russia please contact: • Address: 1, Komsomolskaya Street, Podolsk,Moscow region, 142100, Russia • Phone: +7 (495) 532 62 46 • E-mail: inquiry@corex-depot.com • URL: www.corex-depot.com

  25. THANKYOUFOR YOURATTENTION!

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