Serialization - What's on
Im Auftrag der ECA Academy

Serialization - What's on Im Auftrag der ECA Academy

Hamburg, Germany

Seminar Nr. 17354

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail:


Tobias Beer, EMVO, Belgium
Christian Jertrum, Hospitals Pharmacy Region Midtjylland (midt) Denmark
Dr Ulrich Kissel, EQPA, Germany
Dr Laura Ribeiro, OCP, Portugal
Dr Stephan Schwarze, Bayer, Germany
Steven De Strycker, Federal Agency for Medicines and Health Products, fagg, Belgium


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, round table discussions will provide space for discussing open questions and sharing experience.


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 two Aide Memoires have been published in 2019:
Several months into the operational phase of the EU Verification System a significant number of manufacturers and supply chain actors have not yet connected to the system. Data provided by the European Medicines Verification Organisation (EMVO) estimate that 40% of (theoretical) manufacturers as well as 25% of other supply chain actors (e.g. pharmacies, hospitals, wholesalers, dispensing doctors) have not yet connected to the medicines verification system.

In addition, the Industry is still fighting with false alerts and most of the member states are still in stabilization phases. The EMVO report says that approximatively 3% of all scans undertaken by supply chain actors 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.
The 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 workshops during this training course dealing with questions like:
  •  What are the challenges of the 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?
  •  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?
  •  Is a modification of deviation management required?
  •  What to do if real falsification is the most likely conclusion?


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 new systems are the target group of this event.


Delegated Regulation – Serialization & Anti-Tampering Device – What’s in?
  • Overview and context
  •  Requirements as defined in the Delegated Regulation
  • What can be expected next?
Serialization - The Inspector’s View
  •  Regulatory expectations
  •  Roles and responsibilities for implementation, maintenance, data upload & release
  •  Current issues: connections, false alerts
Serialization – Industry’s Perspective
  •  Implementation challenges
  •  Reality check following February 9, 2019
  •  Current status
  •  Expectations from the industry’s point of view
Serialization – The Perspective of the Qualified Person
  • The QP involvement into regulation 2016/161
  •  Impact of safety features and serialization on certification
  •  Impact of Questions and Answers documents on serialization
  •  Data, data management and QPs
  •  QPs facing too many alerts
  •  The QP´s wish list on serialization
Serialization - Experience on the Wholesaler Scope
  • How to deal with suspected and confirmed falsified medicines
  •  Who should manage communication with the end users
  •  Current issues
Experience with Serialization / FMD at the Hospital Pharmacy
  •  Alerts: When and how to approach the investigation of a suspected pack
  •  What should the end user do with the pack
  •  Current issues
View & Experiences of the EMVO
  •  Readiness and lessons learned of the European supply chain stakeholders
  •  Development of (false) alerts
  •  Stabilization periods across Europe
  •  Enforcement and inspections by National Competent Authorities
Round Tables
Some of the most important topics of this course will be further discussed.
Round Table(s) I
Sharing of Practical Experience
  •  Challenges at the packaging line
  •  Criminals taking advantage of the current situation?
  •  Alert handling process
Moderator: Dr Stephan Schwarze

Round Table(s) II
Handling of Alerts / Deviations / Complaints/ Falsifications
  •  Do we need a new alert management system or will we use established quality systems?
  •  Is a modification of deviation management required?
  •  Safety features and Serialization: How do they impact our complaint management systems?
  •  What to do if real falsification is the most likely conclusion?
Moderator: Dr Ulrich Kissel


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