European QP Association (EQPA), KisselPharmaConsulting
Volker Ditscher
WIPOTEC
Emil Schwan
Swedish Medical Products Agency
Dr Stephan Schwarze
Bayer
Wilfried Weigelt
REA Elektronik
Laura Ribeiro
OCP
Dieter Mößner
Verpackungsexperte
Dr Daniel Dangl
AMVS
Markus Medved
Swedish Medical Products Agency
Note: All times mentioned are CEST.
Objectives
It is the course’s goal to inform about the latest developments regarding the compliance with the Falsified Medicines Directive 2011/62/EU and its Delegated Regulation EU 2016/161. Best practice examples will demonstrate how the requirements on verification of the authenticity of each single medicinal product can be fulfilled and false alerts can be managed efficiently. In addition, global aspects, like aggregation and the different types of coding will be covered.
Background
Since 9th of February 2019 the Commission Delegated Regulation applies. With it the detailed rules for safety features on the packaging of medicinal products for human use are in place and need to be followed. Frequently updated Question and Answer documents have been published in addition to provide guidance. Moreover three Aide Memoires have been published for:
GMP INSPECTIONS OF MANUFACTURERS,
GDP INSPECTIONS OF WHOLESALERS,
INSPECTIONS OF PHARMACIES
COMPLIANCE WITH COMMISSION DELEGATED REGULATION (EU) 2016/161 FOR SAFETY FEATURES.
More than four years in the operational phase of the EU Verification System a significant number of manufacturers and supply chain actors have still not connected to the system.
In addition, the Industry is still fighting with false alerts and most of the member states are still in stabilization phases. Scans undertaken by supply chain actors often lead to false alerts being generated due to various reasons, such as:
Missing data upload into the European Hub,
Incorrect data upload,
Incorrect scanner configuration of end-users,
Pharmacy / hospital software systems not updated,
Procedural reasons,
System not used properly.
This live online training course will support you in collecting, sorting and proper understanding of the relevant requirements related to the defined safety features. Practical examples will be presented and further discussed in corresponding Q&A sessions, dealing with questions like:
What are the challenges of the EU delegated regulation for safety features the supply chain actors are currently facing?
What are the weak points of the current End-to-End verification System?
Will aggregation soon be required in the EU?
What are the requirements regarding serialization / aggregation on a global level?
What are the requirements for Medical Devices?
How could a best practice process of suspected falsified medicines handling may look like?
Do we need a new alert management system or will we use established quality systems?
What to do if a real falsification is the most likely conclusion?
Target Group
Executive and operational managers of all actors of the supply chain (e.g. manufacturers, pharmacies, hospitals, wholesalers, dispensing doctors), as well as IT and engineering staff, responsible for the implementation or operation of the systems are the target group of this event.
The topics provided are also of interest for QA personnel dealing with alerts and complaints, QPs, suppliers of packaging (and authentication technology) and devices, and GMP/GDP Inspectors.
Technical Requirements
We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Testimonials
Seminar Programme as PDF