It is the course’s goal to inform about the latest developments in serialisation & authentication coming from the European and International Regulations such as the Russian Crypto Coding requirements, the EU Directive 2011/62/EC and corresponding Delegated Regulation and the US Drug Supply Chain Security Act (DSCSA). Also, the Medical Device Regulation (EU) 2017/745 coming into force on 26th May 2020 and the UDI-marking requirements in Europe and US will be dealt with. Generally, the challenges and solutions how to comply with serialisation, tamper verification and packaging requirements of medicinal products and the requirements of Medical Devices and Unique Device Identification in the different markets are core content of this course. Best practice examples will demonstrate how the new European and International requirements on verification of the authenticity of each single medicinal product and the new regulations on medical devices can be put into practice. This course will also explain requirements for Artwork Management, Packaging specification and typesetting.
The training course will support you in collecting, sorting and proper understanding of the requirements of the serialisation Requirements in Russia, in Europe, the US and other markets and the Medical Device Regulation. This includes the relevant information related to the Russian Crypto Coding, the defined two EU-safety features (unique identifier and tamper evident closure) and the US and International serialisation requirements. Also, this course will deal with the existing and emerging global serialization and track and trace requirements for medicines and their packaging in markets such as China, Korea, US and others. This course will also deal with Artwork Security and Audit Trails of Artworks Management.
By the end of the MasterClass, the participants will understand:
- The Requirements for Serialisation in Russia, the EU and other markets
- The Serialisations effects and consequences
- The Medical Device Regulation and its effects
- The requirements for Unique Device Identification
- Artwork Management
- Digital Content Management
For 23 years, Dieter Mößner has been working at Edelmann as a technical project manager. He leads projects in Braille application, serialisation, tamper evidence and anti-counterfeiting of pharma and consumer good packaging and consults customers and artwork agencies in artwork creation, print data communication and typesetting workflows. Dieter composed parts of the guidelines “Braille on Folding Cartons”, published by the European Carton Makers Association ECMA. H e is Convenor of CEN/TC 261/SC 5/WG 12 “Marking”. This working group at the European Committee for Standardisation CEN has created the European standards EN 15823:2010 “Braille on Packaging for Medicinal Products” and EN 16679:2014 “Tamper Verification Features for Medicinal Product Packaging”. Since March 2013, he has been chairman of the packaging standards committee N AVp at the G erman Standards Institute DIN.