Live Online Training: Serialization - What's on

Live Online Training: Serialization - What's on

Course No 18382

Note: All times mentioned are CET.

Costs

ECA-Member: EUR 1690,--
Non ECA Member: EUR 1890,--
EU/GMP Inspectorates: EUR 945,--
APIC Member Discount: EUR 1790,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

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

Objectives

It is the Live Online Training’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, Q&A sessions will provide space for discussing open questions and sharing experience.

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 two Aide Memoires have been published in 2019:
  • GMP INSPECTION OF MANUFACTURERS, and
  • GDP INSPECTION OF WHOLESALERS
COMPLIANCE WITH COMMISSION DELEGATED REGULATION (EU) 2016/161 FOR SAFETY FEATURES.
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 1,5 - 3% of all scans undertaken by supply chain actors lead to
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:
  • GMP INSPECTION OF MANUFACTURERS, and
  • GDP INSPECTION OF WHOLESALERS
COMPLIANCE WITH COMMISSION DELEGATED REGULATION (EU) 2016/161 FOR SAFETY FEATURES.
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 1,5 - 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.
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 during this Live Online 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?
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 during this Live Online 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?

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 new 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 GMP/GDP Inspectors.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at thesame time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

Programme Day 1
 
09.00 - 09.15 h Welcome/Introduction
 
09.15 - 10.15 h
Delegated Regulation – Serialization & Anti-Tampering Device – What’s in?
  • Overview and context
  • Requirements as defined in the Delegated Regulation
  • What can be expected next?
10.15 - 10.30 h Break
 
10.30 - 11.30 h
Serialization - The Inspector’s View
  • Regulatory expectations
  • Roles and responsibilities for implementation, maintenance, data upload & release
  • Current issues: connections, false alerts
11.30 - 12.00 h
Q&A Session 1
 
12.00 - 13.00 h Break
 
13.00 - 14.00 h
Serialization – Industry’s Perspective
  • Implementation challenges
  • Reality check following February 9, 2019
  • Current status
  • Expectations from the industry’s point of view
14.00 - 15.15 h Break
15.15 - 16.15 h 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
16.15 - 16.45 h
Q&A Session 2
 
 
Programme Day 2
 
08.30 - 09.30 h
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
09.30 - 10.30 h
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
10.30 - 10.45 h Break
 
10.45 - 11.45 h
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
11.45 - 12.15 h
Q&A Session 3
 
12.15 - 13.15 h Break
 
13.15 - 14.15 h
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?
14.15 - 14.30 h Break
 
14.30 - 15.30 h
Global View: Focus on Russia and Brazil
  • Russian Serialization requirements
  • Implementation and technical challenges
  • Outlook on extension to additional products
  • Brazilian Serialization requirements
  • Serialization, aggregation and commissioning requirements
  • Outlook – who’s next?
15.30 - 16.00 h
Q&A Session 4

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