Serialization

Session #2: Serialization Regulatory Landscape

May 29th, 2019 | 10am (EDT) - 4pm (CEST)

with 

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

Brigitte Naftalin

Regulatory Affairs, Adents

Andreas Andersson

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?

Ask Questions

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.

Get Answers

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.

Follow up

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.

The Open Mic session starts in

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