If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: email@example.com
Thomas Brückner, BPI (German Pharmaceutical Industry Association), Berlin, Germany
Maren Göpfert, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany
Horst Kastrup, Vitapharma Generics, Bad Homburg, Germany
It is the course’s goal to inform about the latest developments in serialisation & authentication coming from the EU directive 2011/62/EC and the corresponding Delegated Regulation as just published in the Official Journal of the European Union. Best practice examples will demonstrate how the new European requirements on verification of the authenticity of each single medicinal product can be put into practice.
Directive 2011/62/EC also known as “EU Falsified Medicine Directive” came into force already in 2011. Not before October 2015, the final draft of the corresponding Delegated Regulation was made known to the public
following the adoption by the EU Commission.
Finally, by 9th February 2016 the “COMMISSION DELEGATED REGULATION (EU) 2016/161” “supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use” was published in the Official Journal of the European Union. As consequence, the rules will be applied from 9th of February 2019 onwards except for some member states with an existing Verification System.
Like many of such regulation it is burdensome to read through these documents and sometimes it is also challenging to capture the relevant content. Key for a successful implementation of the applicable regulation is the understanding of what is really in there for you and what is actually relevant.
The training course will support you in collecting, sorting and proper understanding of the relevant contained information related to the defined safety features, which are
a unique identifier and
tamper evident closures
within the EU. The German Initiative “securPharm” is the only system in the EU which is in compliance with the published delegated regulation that has already been implemented successfully. A report about the current status is part of the training course. Beyond this an insight in the current global landscape of serialisation and coding requirements and system is provided as well.
Practical examples will be presented and further discussed in corresponding workshops during this training course dealing with questions like:
What is the impact of the delegated regulations for the safety features in the EU on the pharmaceutical industry?
What does coding and serialisation mean for manufactures of printed packaging material?
How is the code quality defined and how to test the appropriate code quality?
Which kind of technical challenges have to be considered during the implementation of a serialisation system?
What are the relevant aspects to be addressed from a quality point of view?
Executive and operational managers of pharmaceutical companies, especially from packaging operations, as well as IT and engineering staff, responsible for the implementation or operation of the new systems are the target group of this event.
Suppliers of packaging and authentication technology and pharmaceutical packaging companies are also welcome.
Draft Delegated Act for the Safety Features – Impact