6th Serialization Symposium
Global Serialization and Pharma Trends
Worldwide different initiatives regarding the safety of patients from counterfeit drugs within the legal supply chain are currently planned or already implemented. By releasing the delegated act (EU) 2016/161it is confirmed: From February 9, 2019 onwards drugs, which are subject to prescription, are only allowed to be distributed within Europe, if every single packaging is provided with an individual serial number and the intactness is visible.
Similar initiatives are currently impelled in the United States, Argentina, Brasil, Russia, the Middle East as well as in numerous countries in Asia and the Pacific. Until 2020 a majority of the countries worldwide will have set deadlines for the implementation of serialization.
Representatives from international pharmaceutical manufacturers, licensed pharmaceutical wholesalers, national verification systems, implementing companies, and representatives from other industries in which product traceability is becoming increasingly important will meet again for a two-day event at the Bertelsmann headquarters in Berlin. Presentations and workshops will focus on the global requirements of pharmaceutical packaging serialization as well as current trends related to serialization.
Topics (extract) & Agenda
The participants will discuss with experts and stakeholders from the pharmaceutical industry on topics such as:
- Quo Vadis – Serialization in Russia 2020 and beyond
- FMD: Wholesale License Holders want to know how to start
- Product Traceability Trends in Non-Pharma Industries such as Food and Medical Devices
- How to boost shop floor transparency by integrating Arvato CSDB and PAS-X MES
The 6th Serialization Symposium will be jointly organized by Arvato Systems and TRAXEED - Körber Solutions
Global IT specialist Arvato Systems supports major companies through digital transformation. More than 3,000 staff in over 25 locations epitomize in-depth technology expertise, industry knowledge and focus on customer requirements. Working as a team, we develop innovative IT solutions, transition our clients into the Cloud, integrate digital processes and take on IT systems operation and support.
TRAXEED - Körber Solutions
Under the Traxeed brand, Medipak Systems bundles the Track & Trace activities of its companies Seidenader Maschinenbau and Systec & Services. They are partner for complete pharma serialization solutions from level 1 to level 5 – from serialization and aggregation machines to software and implementation at all levels and from a single source. Traxeed is part of Medipak Systems, the Business Area Pharma Systems of the international Körber technology group.
DMLogic is a proven leader and expert in pharmaceutical serialization and traceability. STEPLogic Trace, is a fully DSCSA and FDA Part 11 compliant comprehensive solution that supports cradle to grave tracking within the distribution center. The STEPLogic Trace solution is targeted to manufacturers and third-party logistics customers who have pharmaceutical clients within their warehouses. Offering aggregation, integration with repository systems/agencies and multiple deployment options, STEPLogic Trace is a proven serialization solution.
GS1 Germany supports companies from all sectors in the adoption and practical implementation of modern communication and process standards, in order to improve the efficiency of their business processes. Within Germany, the company is responsible for the maintenance and continued development of the GS1 article identification system GTIN for globally unique identification, which in turn serves as the basis for bar codes. Moreover, GS1 Germany supports the application of new technologies for fully automatic object identification (EPC/RFID) and for standardised electronic communication (EDI).
Rondo AG develops and produces packaging solutions for the pharmaceutical industry. In addition to standard and special folding cartons, it also offers system solutions and services. Production takes place in Switzerland, the Czech Republic, the USA and Puerto Rico. Worldwide, Rondo’s workforce of around 600 employees produces over two billion folding cartons and package inserts every year.
Werum IT Solutions is the world’s leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical industries. Its PAS-X software product is run by the majority of the world’s top 30 pharmaceutical and biotech companies and also by many mid-sized manufacturers. Werum’s manufacturing IT solutions help pharma manufacturers to increase efficiency, improve productivity, and meet regulatory requirements. Founded in 1969, Werum is headquartered in Lüneburg, Germany, and has many locations in Europe, America, and Asia.
The vast production experience of in labels, leaflets and system solutions for the pharmaceutical industry since 1933 combined with passion for digitalization makes Bähren Druck a true specialist for tailor made solutions. The latest offerings are security labels to comply with the FMD 2011/62/EU. Bähren Druck supports your serialization project with tamper-evident labels and pre-serialized labels.
Database system of the pharmaceutical industry
ACS PharmaProtect GmbH is a part of the securPharm project and operates the database system of the pharmaceutical industry for the authentication of medicines in Germany according the provisions of the Delegated Regulation. Shareholder of the ACS are the pharmaceutical associations BAH, BPI, Pro Generika and vfa in equal shares.
An architectural jewel in a setting filled with history
Photo Bertelsmann Premises: © Bertelsmann SE & Co. KGaA
Bertelsmann’s “Unter den Linden 1” is a location which has evolved over the years into a vibrant and diverse space for cultural exchange, music and literature. Here, opinion makers discuss politics, science and economics, media creators engage with their public in reactions to their work, Penguin-Random-House authors read from their books and UFA films are shown. "Unter den Linden 1" has become an important fixture in Berlin’s lively political and social scene.
Adress: Unter den Linden 1 | 10117 Berlin
Sightseeing Tour & Evening event
Lean back in the sightseeing bus after the first day of the conference and discover Berlin's many sides and historical monuments on your way to the evening event. End of the tour: Haus Ungarn!
The new Haus Ungarn, located in close proximity to the Alexanderplatz, offers a unique combination of modern building elements as well as the East charm, which is rarely found in Berlin. A big foyer, an old wood-paneled cinema hall as well as an own outdoor area make the Haus Ungarn the ideal event space in the center of Berlin.
Adress: Karl-Liebknecht-Straße 9 | 10178 Berlin
Entrance next to TITUS