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The training course will support you in collecting, sorting and proper understanding of the requirements of the EU Falsified Medicines Directive. This includes the relevant information related to the defined two EU-safety features, which are a unique identifier and tamper evident closures to be applied to the packaging of medicinal products within the EU starting 9th February 2019. 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.


Learning Outcomes:

  • Take a closer look on how the new European requirements on verification of the authenticity of each single medicinal product can be put into practice
  • Experience how to comply with serialisation, tamper verification and packaging requirements of medicinal products
  • Understand The Print Quality of Barcodes and 2D Matrixcodes
  • Have a chance to meet the The Requirements for EU-Falsified Medicines Directive 2019
  • Learn about about the latest developments in serialisation & authentication coming from the EU directive 2011/62/EC
  • Understand the requirements for Artwork Management, Packaging specification and typesetting

By the end of the MasterClass, the participants will understand:

• The Requirements for EU-Falsified Medicines Directive 2019

• The Serialisatons Effects and consequences

• EU falsified Medicines Directive

• Artwork Management

• Digital Content Management

Request detailed Agenda - Pharma Regulations and Technical MasterClass


The Trainer:       

Since 21 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. He 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 NAVp at the German Standards Institute DIN.