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.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://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 the same 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.
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