Learning outcomes
Training description
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.
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
Training schedule
Day one
08:30 Registration & Networking with Welcome Coffee
08:45 Welcome – Overview and Target of the Training Course
Session 1
Worldwide Serialisation Requirements – Implications and consequences for the pharma industry09:00 Overview Global Serialization Requirements
11:00 Tea, Coffee, Networking
Session 2
EU falsified Medicines Directive – How to implement11:20 Requirements EU-Falsified Medicines Directive 2019/securPharm
13:00 Luncheon & Networking
14:00 Technical and Organizational Implementation of Serialization at the Pharmaceutical Manufacturer
16:00 Tea, Coffee, Networking
16:20 DIN EN 16679 “Tamper Verification Features for Medicinal Product Packaging” – Practical Implementation
17:50 End of day 1
Day two
08:30 Tea, Coffee, Networking
Session 3
Artwork Management – Security and Audit Trails – Serialisation & Tamper Evidence08:50 Recap from Day 1
09:00 Coding / Serialisation / Artwork at the Manufacturer of Printed Packaging Materials
10:30 Tea, Coffee, Networking
10:50 Qualification and Validation of Serialisation and Tamper Verification Technologies in Pharma Packaging
12:30 Luncheon & Networking
13:15 Artwork Management – Security and Audit Trails
15:00 Workshop summary and Q&A
15:15 Farewell Tea, Coffee and Networking
15:45 End of day 2
Training Program
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Get to know the Expert 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.
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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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