Dr Ulrich Kissel, European QP Association, KisselPharmaConsulting, Germany
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 Webinar will inform about the latest developments regarding the compliance with the Falsified Medicines Directive 2011/62/EU and its Delegated Regulation EU 2016/161.
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.
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
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
Recording from 19 May 2020
Duration of recording: about 1,5 h.