Swissmedic Annual Report 2018

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84 Information technology and telecommunication Information technology and telecommunication IT management IT management handles the strategic and operational planning and provision of information and communication technology (ICT). Key tools in doing so are the strategic direction of IT services, IT architecture and short- to longterm project planning. IT management is responsible for cost-effective, legally compliant procurement, sustainable development and the stable, secure availability of IT resources and services. Activities • Activities focused on adapting business processes and the supporting ICT systems in preparation for the entry into force in 2019 of the revised Therapeutic Products Act and its implementing provisions. • IT innovation management was expanded. This involves the IT unit working in a dialogue with the business areas to analyse the effects on Swissmedic of current technical developments such as algorithmics, big data, real-world evidence, the Internet of things and deep learning. Suitable measures are then developed. • The dialogue between the business areas and IT on project planning was also intensified and put on a more formal footing. As a result, it is now possible to obtain a more holistic view of the business requirements that IT has to fulfil, and consequently to use synergies more effectively. • Reviews of IT processes focused on archiving and information security. Solution development Implementation of the projects road map represents an important foundation in achieving Swissmedic’s strategic objectives. Building on the investments in renewals made in recent years, additional project support functions are continually developed and upgraded. Investments continue to be focused not only on internal process automation projects, but also on expanding options for communicating electronically with the authorities via the Internet (eGovernment). Activities • Four parallel work packages created the framework for introducing the new processes associated with the revision of the Therapeutic Products Act and its implementing provisions and the revision of the Medicinal Products Licensing Ordinance in preparation for the implementation of the Medicrime Convention. The new and modified functions went live at the end of December so they would be ready for use starting in January 2019. • A new and optimised IT application for pharmacovigilance notifications was rolled out in mid-2018. • Additional eGovernment services that include authorisation documents, product certificates and GMP/GDP certificates came on stream. • As the authority responsible for enforcing the revised legal provisions governing medical devices, Swissmedic has until May 2020 to make all necessary preparations for implementing the new medical devices regulations in Switzerland. Accordingly, the project set up to deliver the appropriate processes, forms, documents and systems started work at the end of 2018. • In mid-2018, a new IT application that provides support for the authorisation of Asian medicinal products without an indication under the notification procedure was rolled out.
Information technology and telecommunication 85 IT operations, user support, maintenance and continuous improvements Deriving a benefit from IT solutions requires trained, informed users, easily accessible, secure and well-maintained infrastructures, the constant exploitation of potential efficiency drivers, and rapid, simple access to support services. Service and support management has the vital task of delivering and overseeing these support capabilities. Activities • The public tendering process for bids to replace the central IT platform and internal first-level IT support in the medium term was successfully completed. • Swissmedic employees are now benefiting from a simplified, clearer time recording system. • A new IT workplace system was designed.
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Annual Report 2018
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3 Contents Foreword by Stéphane Ro
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5 Standards Legal framework Legisla
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7 Raimund Bruhin, director “Not t
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9 The situation subsequently calmed
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11 Basis for development cooperatio
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13 Better protection against defect
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15 undercover investigations in one
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17 Autologous transplant products T
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19 Temporary authorisation: rapid a
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21 Number of authorisations by disp
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Market access | Marketing authorisa
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Page 33 and 34: Market access | Marketing authorisa
Page 35 and 36: 35 Variations requiring approval an
Page 37 and 38: Market access | Marketing authorisa
Page 39 and 40: Market access | Licensing 39 Licens
Page 41 and 42: Market access | Licensing 41 Clinic
Page 43 and 44: Market access l Inspections 43 Insp
Page 45 and 46: Market access l Inspections 45 GLP
Page 47 and 48: Market access | Licensing 47 Licens
Page 49 and 50: Market access | Licensing 49 Analys
Page 51 and 52: Market access | Medicinal products
Page 61 and 62: Market access | Medical devices 61
Page 67 and 68: Standards 67 Standards Legal framew
Page 69 and 70: Standards 69 Pharmacopoeia The phar
Page 71 and 72: Penal law 71 Investigative measures
Page 73 and 74: Penal law 73 Decisions / verdicts b
Page 75 and 76: Stakeholder management 75 Press rel
Page 77 and 78: Stakeholder management 77 Events Sw
Page 79 and 80: Stakeholder management 79 Collabora
Page 81 and 82: Stakeholder management 81 • Swiss
Page 83: Stakeholder management 83 Special a
Page 87 and 88: Corporate Governance 87 Agency Coun
Page 89 and 90: Corporate Governance 89 Chair Stép
Page 91 and 92: 91 Remuneration Remuneration for th
Page 93 and 94: Organisation 93 Members of the Vete
Page 95 and 96: Organisation 95 Nicole, Messi Mara,
Page 97 and 98: Balance sheet 97 Balance sheet (in
Page 99 and 100: Erfolgsrechnung 99
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Swissmedic Annual Report 2018

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