Session #2: Serialization Regulatory Landscape
May 29th, 2019 | 10am (EDT) - 4pm (CEST)
Brigitte Naftalin, Regulatory Affairs, Adents
Andreas Andersson, Regional Sales Manager, Adents
No boring product presentation, no salesy speech...you ask questions, we answer!
ASK THE EXPERTS!
Join us for the Adents’ Serialization Open Mic Series enabling you to ask any questions
related to global serialization regulatory requirements (DSCSA, EU FMD, Russia , Saudi etc.)
to a subject matter expert and get straight answers during a live session.
Meet the Experts
Regulatory Affairs, Adents
Regional Sales Manager, Adents
Some Questions Already Sent By Your Peers
- Where aggregation is mandatory and when?
- What are the main milestones for compliance deadlines in Russia and China?
- How will Russian cripto codes work? which kind of transactions do we need to report?
- Is the list of master data (from regulatory point of view) for the products already defined on the Russia Market? which are the Product information that must be uploaded to MDLP system?
- Chinese authorities have recently released guidance documents, can you elaborate on what is required and when?
- Do we see pharmaceutical serialization crossing over to other industries, like cosmetics? What is the state of UDI in the industry?
- FDA granted 1-year grace period to pharma industry in the US (26th Nov 2018) after they discovered that only 50% of manufacturers were likely to meet deadline. What is the status now in the US and Europe? What are the risks for manufacturers?
Submit a question related to the topic of the session either when signing up or live chatting during the Open Mic. We will publish on the page some of the key questions.
The expert will try to answer a maximum of questions during the live session. Questions submitted prior to the sessions will be answered first but we may also pick questions sent live.
The Open Mic will be recorded entirely and you will be able to watch a replay quickly after the live session. We will answer your question(s) via email if it's not selected during the live session.