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 industry09:00 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 USA13:00 Luncheon
14:00 Technical and Organizational Implementation of Serialization at the Pharmaceutical
Manufacturer16:00 Tea , Coffee, Networking
16:20 DIN EN 16679 / ISO 21976 “Tamper Verification Features for Medicinal Product
Packaging” – Practical Implementation17:50 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 EvidenceCoding / 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
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Get to know the Expert Trainer
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 Location
Novotel Budapest Danube
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1027 Budapest
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FAQ
The client has the right to cancel his/her registration in the event.
There is a 50% liability on all conference registrations once made, whether the booking was made through our website or via e–mail/ telephone/ fax.
If the client cancels with more than 8 weeks’s advance notice, GLC shall be entitled to an amount equivalent to 50% of the conference fee and 16 EUR administration charge. In case the client has already made his/her payment, this will be deducted from the conference fee GLC has already received and the remainder will be refunded. If no conference fee has been received prior to the cancellation request, GLC will issue an invoice for the cancellation fee (the amount equivalent to 50% of the conference fee and 16 EUR administration charge), which the client must pay immediately upon receipt. No refunds are available for cancellations received with 8 week’s (or less) advance notice or in case the client fails to attend the conference. In these cases, the full amount of the conference fee must be paid.
- Get the timing right.
Many people are afraid to request for training budget, because they can’t seem to find the “perfect time” to do it. Well, there’s no perfect time to ask for it, but there are definitely some moments that are better than others. For instance, if your boss is about to take a two week vacation, he/she might be in a good mood. If he/she just lost a major account, may not be wise at that juncture. - Make a case for yourself
When you ask for budget, you should be prepared with specific details and explanations about what is in it for the company and you’re superior. If you go into a meeting and just say, “I want to get budget for a conference,” it’s likely that your request won’t be taken seriously. If you want to plan ahead, then you should be prepared to explain the following points:
1. Start by stating your accomplishments
2. Show that you’re ready for more responsibility and eager to learn
3. Describe:
a) How this event will increase your productivity?
b) How you will need less supervision
c) How you can bring back the knowledge to the company
4. Follow up