Delegated Regulation – Serialization & Anti-Tampering Device – What’s in?
- Overview and context
- Requirements as defined in the Delegated Regulation
- What can be expected next?
Serialization - The Inspector’s View
- Regulatory expectations
- Roles and responsibilities for implementation, maintenance, data upload & release
- Current issues: connections, false alerts
Serialization – Industry’s Perspective
- Implementation challenges
- Reality check following February 9, 2019
- Current status
- Expectations from the industry’s point of view
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
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
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
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
Some of the most important topics of this course will be further discussed.
Round Table(s) I
Sharing of Practical Experience
- Challenges at the packaging line
- Criminals taking advantage of the current situation?
- Alert handling process
Moderator: Dr Stephan Schwarze
Round Table(s) II
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?
Moderator: Dr Ulrich Kissel