Corporate Presentation & Offer for SAP ATTP December 2015

Transcription

1 Corporate Presentation & Offer for SAP ATTP December 2015 Page : 1

2 Page : 2 Content Our Vision Our Company Business Challenges SAP Advanced Track and Trace for Pharmaceuticals (ATTP) Our Offer

3 Our Vision Page : 3

4 Our Vision We inspire individuals and organizations to work more effectively and efficiently, and create greater choice in the domain of work, for the benefit of all concerned. Our business has a positive impact on thousands of people every day by helping them to better work, better life and this is our common purpose and the way in which we contribute to boost entrepreneurship. This is what we do, this is what we know about, this is what we care about, this is what we are all about. Page : 4

5 Our Company Page : 5

6 Our services SAP Implementation Services TEKA Systems has the largest certified SAP consultant s team in the Balkan area, around 120 certified SAP consultants, who is specialized in several industry solutions in SAP applications and Database & Technology. Having in-depth knowledge of functionality and product technology experience can provide end-to-end solutions from design, implementation, support, roll-out and upgrade services for SAP products. SAP Support Services TEKA Systems offers supporting services for the maintenance of SAP systems. TEKA Systems has developed a dedicated support team that deals with issues arising from SLA contracts with their customers. The service department offers a variety of services like bug fixing, early checks, remote consulting, etc. Outsourcing Services TEKA Systems help the customers to reduce the costs, increase the productivity, be accurate with reliable data and services and be faster without losing their flexibility. TEKA Systems provides outsourcing services for Payroll, System Administration, data entry and month closing for SAP products. Choose to outsource your SAP hardware and infrastructure through our strategic partnerships and let us manage the software applications for you. We offer our clients the opportunity to externalize business processes to TEKA Systems in which we are credited with a wide sectorial and functional experience with the purpose of making them more cost efficient and less risk controlled TEKA Systems. All rights reserved. Internal Use Page 6 : 6

7 Projects around the World Every day we support around 12,000 SAP users in more than 20 countries worldwide and in five continents 2015 TEKA Systems. All rights reserved. Internal Use Page 7 : 7

8 Deep experience in Pharmaceutical Industry Pharmathen Indernational Pharmathen was founded in 1969 in Athens, as a private pharmaceutical company, and is focused on the development and marketing of pharmaceuticals, with a strong position in generics. With 3 state of the art research laboratories and 2 manufacturing units, Pharmathen is a completely vertically integrated company and its activities extend from the development of pharmaceutical products up to their distribution. The company s human resources include more than 900 people who work in the sectors of Research & Development (R&D), production and distribution of drugs to more than 80 countries worldwide. Today Pharmathen s products are approved in all EU markets and distribution rights have been granted to the largest pharmaceutical companies in the world, particularly in Europe, the United States of America and Canada. Sales of Pharmathen products reached a total of 178 million in In 2007 TEKA Systems started with the implementation of the SAP ERP in order to cover all the Pharmathen processes. Since the first implementation of SAP ERP until today we have deliver solutions in multiple areas such as Analytics (SAP BI), Planning and Consolidation (SAP BPC) and recently in the Contract Management, through the SAP CRM functionality TEKA Systems. All rights reserved. Internal Use Page 8 : 8

9 Deep experience in Pharmaceutical Industry FAMAR FAMAR was established in 1949 in Greece and is one of Europe s leading providers of Contract Manufacturing and Development Services to the Pharmaceutical and Health & Beauty industry. The company The company, manufactures, packs and ships over 770 million packs p.a. Over the past years FAMAR has pursued a twofold strategy of aggressive growth and consolidation of our operations. The result has been a series of acquisitions in France, Italy, the Netherlands, Spain and Greece as well as a furthering of expansion and consolidation in existing markets. Today, Famar operates a network of 11 production sites in 5 European countries, 4 development centers, and 3 distribution centers. FAMAR offers pharmaceutical production, pharmaceutical development, health and beauty R&D and production, as well as logistics services to a client base of over 150 global, multinational and local customers. TEKA Systems implemented SAP ECC 6.0 back in for FAMAR Pharmaceutical Group of companies. Five individual manufacturing plants in Greece went live successfully at start of 2009 covering the logistics, production and financials SAP modules. The whole project was developed based on the required GMP processes and CSV methodology. TEKA Systems also supported successfully all post-live requirements of the FAMAR Group in Greece, France and Nederland s. SAP BW implemented the same year (2009). TEKA Systems also developed special interfaces for pharmaceutical weighing systems (ELAN XFP) with SAP ERP. Since 2009 we are supporting the daily operations for more than 200 SAP users of FAMAR group, through our dedicated supporting department TEKA Systems. All rights reserved. Internal Use Page 9 : 9

10 Deep experience in Pharmaceutical Industry VIANEX Vianex was established in 1924 and with more than 90 years of experience in the pharmaceutical field having demonstrated exceptional business achievements in a wide range of activities such as manufacturing, licensing, marketing, exporting and distribution of pharmaceutical products. Vianex, having four (4) state-of-art fully specialized Manufacturing Plants guarantees outstanding production capabilities. The company covers the entire spectrum of manufacturing activities while it continuously upgrades the range of services. During the last decades, Vianex has established successfully partnerships with well-known Pharmaceutical Firms worldwide based on varied distinct Licensees as well as distribution and contract Manufacturing Agreement. Around 300 millions annual revenue at 2014 VIANEX is one of the leading pharmaceutical company in the Balkan area. We are supporting the daily operations of VIANEX through the dedicated supporting department of our company TEKA Systems. All rights reserved. Internal Use Page 10 : 10

11 Deep experience in Pharmaceutical Industry DEMO S.A. DEMO S.A. is an industrial and commercial organization established in 1965 and active in the production and sales of pharmaceutical products. DEMO is one of the major pharmaceutical manufacturers in Greece with a very strong presence in the hospital market, ranking first among the pharmaceutical companies in terms of sold units. With an annual turnover of 112,000,000 EUR in 2014 and average annual growth rates of 22% over the past 8 years, DEMO is ranked as one of the top pharmaceutical companies in the region. Currently DEMO S.A. has a presence in more than 50 countries worldwide including countries in Europe, Asia, Africa, Oceania & the Middle East and has registered more than 750 formulations globally and are continuously expanding our brand worldwide. During the last years we delivered a series of SAP projects in DEMO S.A. and among others, we have implemented the Quality Management process into SAP ECC as also we delivered into 2015 a project for the costing analysis of the production process TEKA Systems. All rights reserved. Internal Use Page 11 : 11

12 Business Challenges Page : 12

13 Background - Facts on falsified medicines According to the World Health Organization: 50% of drugs purchased from illegal internet resources are counterfeit Source: WHO Fact sheet N 275, May % of drugs in Asia, Africa or LATAM are expected counterfeit Source: 10% of prescription drugs sold worldwide are counterfeit (the packaging may be almost identical but the ingredients within the product are often absent or at lower dose than stated, or the product has been contaminated with other dangerous ingredients such as arsenic, heavy metals, pesticide, ink, and leaded paints) Source: TEKA Systems. All rights reserved. Internal Use Page 13 : 13

14 Fake products some impressive figures The global volume of trade in fake goods stands at over 200 billion per year a similar magnitude to the market for illegal drugs Between 2010 and 2011, the volume of fake articles detained by European customs grew by 11% In 2011 alone, 115 million fake goods were detained at the EU borders, with an overall value of over 1.2 billion Medicines are at the top of the list of detained EU articles (24%) In 2011, 27 million fake medicines were detained by European authorities Source: TEKA Systems. All rights reserved. Internal Use Page 14 : 14

15 External Challenges Legislation Existing legislation is understood and can be handled (Turkey, China, Argentina, India). Some legislation is well understood and is currently being detailed out (EU FMD, US DSCSA) others bear some or many uncertainties (Korea, Brazil). Regulations are evolving right now: India just published guidance for reporting by Oct. 2015! No Specs! China: may add veterinary drugs Korea defines regulatory reporting to become active in 2015! No Specs! Brazil Network to be defined -> recent GS1 publication Ukraine, Jordan, Saudi, Japan?? Volumes Especially generics manufacturers have to deal with excessively large numbers of units Aggregation requirements multiply the number of events by a factor 5 Number of Messages explodes if several messages have to be exchanged between stakeholders: Brazil: number of messages ~ number of units * length of supply chain Collaboration Collaboration with regulatory agencies can be handled fairly easily: 1 connection per country Collaboration along the supply chain adds a new level of complexity 100s 1000s of connections Very different players ($10m CMO -> $100b US Wholesaler) Additional message choreography (Brazil) creates a message mayhem if not managed properly 2015 TEKA Systems. All rights reserved. Internal Use Page 15 : 15

16 Different requirements worldwide Countries require an obligatory safety feature, namely a Unique Product Identifier (UPI) on the outer packaging of the medicines 2015 TEKA Systems. All rights reserved. Internal Use Page 16 : 16

17 Drive Process Changes! Packaging Lines Warehouse Management High investments required to make existing packaging lines ready for serialization ($250k per line) and aggregation (+ $250k per line) Downtime for changes to buildings & packaging lines Reduced OEE initially - potentially increase OEE over time If aggregation is required warehouse processes will change significantly Requires an integrated application that allows to handle serialized and non-serialized items together - by the same people - at the same time - on the same device - in the same transaction. Contract Manufacturing Some CMOs might not be ready other CMOs might execute serialization and aggregation on your behalf Ensure collaboration on all levels with key CMOs but also ensure flexibility to switch to in-house production. IT Management Message transmission & content require monitoring by both IT and business users Huge data volumes require dedicated archiving strategy 2015 TEKA Systems. All rights reserved. Internal Use Page 17 : 17

18 SAP Advanced Track and Trace for Pharmaceuticals (ATTP) Page : 18

19 Why Customers asked SAP to invest into SAP ATTP? During the period of , SAP received several requests from the Pharma Customer installed base of SAP Auto-Id Infrastructure/ SAP Object Event Repository to bring SAP Solutions for serialization in Pharmaceuticals to the next level. Reasons Demand/ requirements for more focused Pharma specific functionality (Master data, integration objects, process integration) Commitment on the delivery of currently required and expected country reporting packages and associated functionality Scaling for the expected volume limits of performance on then current SAP Auto-ID Infrastructure/ SAP Object Event Repository Severe concerns as to alternatives in the solution market place as to viable solutions on which one can place a bet for must do compliance to retain the right to sell into these regulated markets 2015 TEKA Systems. All rights reserved. Internal Use Page 19 : 19

20 SAP ATTP Allows you Summary SAP Advanced Track and Trace for Pharmaceuticals provides a corporate serialization repository & management solution with regulatory reporting interfaces, supporting compliance to international legislation to fight falsified medicines It allows you to: Report serial number events to authorities and business partners, enabling compliance with international regulations Integrate with ERP, warehouse management, packaging lines Capture serial numbers from warehouse systems & packaging lines anywhere and store serial number events centrally Track & trace serial number of medicinal sales units and their aggregations Track batches and their serial number relation Globally manage number ranges and randomized or sequential serial number lists Browse and effect internal reporting on usage, distribution of serial numbers globally 2015 TEKA Systems. All rights reserved. Internal Use Page 20 : 20

21 SAP is making a difference Simplify regulatory reporting compliant with different international directives with countryspecific content. Integrate serialization into your business processes with SAP ERP, packaging line, and warehouse integration. Manage serialization data volume that will grow to more than 10 times what it is today by SAP Advanced Track and Trace for Pharmaceutical integrates with your internal business operations and with your supply chain network 2015 TEKA Systems. All rights reserved. Internal Use Page 21 : 21

22 Benefits: SAP Advanced Track and Trace for Pharmaceuticals Comply Cost Scale Effectively comply with global serialization requirements, including different formats and countryspecific reporting from a single corporate serialization repository. Benefit from efficient integration of a corporate-level pharmaceutical serialization solution with your business processes and supply chain network, while reducing TCO and compliance cost. Efficiently scale with a pharmaceutical solution capable of handling large serialization data volumes. Reduce cost/ TCO of compliance Reduce cost of business process integration Reduce cost of platform operation future proof investment 2015 TEKA Systems. All rights reserved. Internal Use Page 22 : 22

23 SAP Advanced Track and Trace for Pharmaceuticals compliant reporting interfaces and predefined country version content for regulatory reporting country versions available: Argentina, China, Turkey, USA additional country versions planned efficient SAP ERP master data integration ERP integration of trade items, locations and business partners efficient business process integration integrate with ERP transactions, warehouse management systems, and packaging lines warehouse integration toolkit for integration to ERP Logistics Execution System WMS global serialization repository capture serialized trade item events centrally view serialized trade item events with the repository browser supports GS1 standards: core elements of EPCIS 1.1, EPCIS core business vocabulary, Tag Data Standard 1.9 number ranges manage global number pools randomized and sequential serial number lists features an in-built randomizer track & trace serialized trade items, lot events trade item up to pallet hierarchies (aggregations) related business transactions government and business partner reporting messages 2015 TEKA Systems. All rights reserved. Internal Use Page 23 : 23

24 Our Offer Page : 24

25 Dedicate consulting team for the SAP ATTP SAP Implementation Services on Level 4 Our consulting team has huge experience on the Serialization / Track & Trace pharmaceutical business. The same consulting team is already trained for the new product of SAP, the SAP ATTP We are on a close collaboration with the SAP for the product development and the upcoming changes on the specific industry We are offering SAP consulting and SAP technical services (development and basis) related to the serialization / track & trace projects We are offering competitive rates regarding the huge experience of the consulting team 2015 TEKA Systems. All rights reserved. Internal Use Page 25 : 25

26 Contact Us Mr. John Syrigos Head of Business Development TEKA Systems S.A. 252 Piraeus St., 17778, Tavros - Greece T +30(210) E jsirigos@teka.vionet.gr W 26