Learning outcomes

Training description

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.

Training schedule

Day one

  • 08:30 Registration, Welcome Tea, Coffee, Networking

  • 08:45 Session 1:
    Worldwide Serialisation Requirements – Implications and consequences for the
    pharma industry

  • 09:00 Overview Global Serialization Requirements

  • 11:00 Tea, Coffee, Networking

  • 11:20 Session 2:
    Russia, EU-Falsified Medicines Directive and US-DSCSA – How to implement
    Requirements for Russia, Europe and USA

  • 13:00 Luncheon

  • 14:00 Technical and Organizational Implementation of Serialization at the Pharmaceutical
    Manufacturer

  • 16:00 Tea , Coffee, Networking

  • 16:20 DIN EN 16679 / ISO 21976 “Tamper Verification Features for Medicinal Product
    Packaging” – Practical Implementation

  • 17:50 End of Day 1

Day two

  • 08:45 Tea, Coffee, Networking

  • 09:00 Session 3: Medical Device Regulation and Unique Device Identification

    European and US Medical Device Regulations and UDI Marking

  • 10:30 Tea, Coffee, Networking

  • 10:50 Session 4
    Artwork Management – Security and Audit Trails – Serialisation & Tamper Evidence

    Coding / Serialisation / Artwork at the Manufacturer of Printed Packaging Materials

  • 12:30 Luncheon

  • 13:15 Session 5: Artwork Management and typesetting – Security and Audit Trails – Part 1

  • 14:30 Tea, Coffee, Networking

  • 14:45 Artwork Management and typesetting – Security and Audit Trails Part 2

  • 16:00 End of Day 1

Training Program

Request detailed Agenda - Medical Device Regulation 2020 MasterClass

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Get to know the Expert Trainer

Dieter Mößner
Dieter MößnerProject Engineer Pharma Edelmann GmbH

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. 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 N AVp at the G erman Standards Institute DIN.

Who should attend?

This course is designed for executive and operational managers of pharmaceutical companies, especially from packaging operations, as well as IT, artwork operators and engineering staff, responsible for the implementation or operation of the new system. Suppliers of packaging and authentication technology and pharmaceutical packaging companies are also welcome.

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Hotel Venue

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Room reservation

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Hotel Location

Novotel Budapest Danube
Bem rkp. 33-34
1027 Budapest
Hungary

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You might find free to attend events which are usually organized by a solution/service provider within the industry. Unlike at free to attend events, on a paid event you will find more diverse industry knowledge rather than presentations related to services or solutions.
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We understand that not all senior-level professionals might be available on the dates. As the event is an annual event, most of the attendees try to postpone their engagements or send a small group from their teams to benefit from the conference.

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