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 industry

  • 09:00 Overview Global Serialization Requirements

  • 11:00 Tea, Coffee, Networking

  • Session 2
    EU falsified Medicines Directive – How to implement

  • 11:20 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 Evidence

  • 08:50 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

Dieter Mößner
Dieter MößnerProject Engineer Pharma, Edelmann GmbH

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

You can always register without a name using the TBA [To Be Announced] option. Please indicate TBA instead of the delegate name and 2 weeks prior to the event you are able to send the delegate name/s to booking[at]glceurope.com
While we are not happy to see you cancel your registration, we understand that “life happens” and other obligations come up. Our refund schedule is as follows:
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.
In general no VAT is applied based on the Hungarian VAT law with the exception of individual payment [when you would like to pay from your own budget and not from the company’s budget] and for Hungarian companies where 27% VAT is applicable which is refundable at the end of the company’s fiscal year.
Our hospitality partners usually have options available for parking places, however it can change from event to event. If you would like to receive more information on parking please e-mail our colleague susanna.juhasz[at]glceurope.com.
We provide a conference documentation pack which includes: conference agenda, notes pages and attendee information. Soft copies of some of the presentation are available on USB-flash-drives for each delegate. You may bring your laptop, tablet or other mobile device so you are able to review the presentations while they are being presented. Free Wi-Fi will be provided and outlets will be available for recharging computers, mobile devices and phones. We highly recommend you to bring along your business cards and a desire to learn from some of the industry’s leading experts.
The dress code is business casual. Feel free to leave the suits and ties at home this time. We do suggest you bring a sweater or dress in layers, as the conference room temperature may fluctuate.
Any of our staff members at the event will be delighted to help you. You can contact us for free via WhatsApp or Viber or any time over the phone or via e-mail or post.
  1. 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.
  2. 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
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.
In case you cannot attend for both days, you can always attend for just 1 day of the event. In this case we will send you all presentations of the 2 days. The participation fee is 70% of the original investment. In case you would like to attend the event for just 1 day please contact us on booking[at]glceurope.com
In case you are busy on 1 of the days, you certainly can split the 2 day conference with one of your colleague. All you need to do is send us an e-mail to booking[at]glceurope.com
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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