Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Referent:innen
Volker Ditscher
WIPOTEC
Emil Schwan
Swedish Medical Products Agency
Wilfried Weigelt
REA Elektronik
Laura Ribeiro
OCP
Dieter Mößner
Verpackungsexperte
Note: All times mentioned are CEST.
Zielsetzung
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.
Hintergrund
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:
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:
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?
Zielgruppe
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.
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.
Programm
Gesamtes Programm als PDF herunterladen
Programme Day 1
EU FMD and Associated Regulations
- Overview and context
- Requirements as defined in the Delegated Regulation
- What can be expected next?
Regulators` View
- GMP/GDP Regulatory expectations
- Approval of artwork and InformationExamples for “Artwork Errors” including not applying correct serialisation or uploading incorrectly
Q&A Session 1
Handling of Alerts: View of an NMVO
- Successful handling of alerts
- How the challenges regarding alerts are addressed
- How the stakeholders were brought on board
- How the number of alerts was brought under control
View of a Wholesaler
- How to deal with suspected and confirmed falsified medicines
- Who should manage communication with the end users
- Current issues
View of a QP
- 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?
- Impact of safety features and serialization on certification
- Data, data management and QPs
- The QP´s wish list on serialization
Q&A Session 2
Programme Day 2
Aggregation - Practical Examples:
Aggregation with Folding boxes, Bundles, Outer Packaging, Pallets
Aggregation with Folding boxes, Bundles, Outer Packaging, Pallets
- Selected regional requirements for Aggregation (e.g. Turkey, US, …)
- Practical examples of Track & Trace Systems (from Folding Boxes to Pallets)
Coding: Practical Examples
- Requirements & Practical Examples
- Printing, Coding & Control
- Scanning
View of a Pharma Company
- Implementation challenges (EU)
- Current Status (EU)
- Expectations & Global Challenges: Canada, Russia, Ecuador
Serialization: Medical Devices
- Overview
- Requirements of the Medical Device Regulation (MDR)
- UDI (Unique Device Identification) and Eudamed Database
- Coding techniques for UDI
- Testing and verification of data
Q&A Session 3
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