Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Referierende
Shortcuts: compact learning units of 1–3 hours – perfect for a quick overview or a focused deep dive into a specific topic. Book online, receive access within minutes and benefit from 7 days of on-demand availability, giving you maximum flexibility in your day-to-day work.
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Zielgruppe
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.
Zielsetzung
Since 9th of February 2019 the Commission Delegated Regulation 2016/161 applies in the EU. 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.
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.
This Shortcut will inform about the latest developments regarding the compliance with the Falsified Medicines Directive 2011/62/EU and its Delegated Regulation EU 2016/161.
Programm
Serialization - discussion and training / experience exchange on
- Status on serialization in industry and across EU
- The QP involvement into regulation 2016/161
- Issues and experiences (e.g. complaints & false alerts)
- Questions and Answers (Q&As) on Safety Features for Medicinal Products for Human use – What needs to be considered?
- Aide Memoire on Serialization (GMP-Inspections) – How to be compliant?
- Aide Memoire on Distribution and Warehousing (GDP-Inspections) - How to deal with suspected and confirmed falsified medicines?
- Potential further development – What you need to know
Weitere Informationen
The purchase process for the GMP & GDP Shortcuts is handled via the sales platform Digistore24 (www.digistore24.com). Please understand that it is not possible to place an order on account in this case.
By clicking the “Book now” button at the top right, you will be redirected to Digistore24. After successful payment, you will automatically receive a confirmation email from Digistore24 and an email from Memberspot (our streaming provider) asking you to register.
Afterwards, you will have access to the purchased video for 7 days.
Please note: The booking is valid only for the registered participants. The use by other persons is prohibited and constitutes an infringement of copyright.
Presentation and certificate:
Starting from the purchase date, the presentation will be available for you to download in Memberspot for 7 days. Afterwards, the participants can download a certificate of attendance.
Contacts
Questions regarding content:
Dr Andrea Kühn-Hebecker, +49 6221 84 44-35, kuehn@concept-heidelberg.de
Questions regarding Organisation:
Ms Isabell Helm, +49 6221 84 44-49, helm@concept-heidelberg.de
Duration of the shortcut: 1h 30m
Recorded in May 2020
Please note:
When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
Teilnahmegebühr
| Regular Fee*: | € 399,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
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