Industry View: Consequences of the New Variations Regulation for the ECTD
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Industry View: Consequences of the New Variations Regulation for the ECTD
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Electronic submissions can substantially reduce submission time, allowing for a quicker release of products onto the market. However, the implementation and handling of eCTD can be problematic due to different standards at each European agency.
In this interview Dr. Hannes Perschinka, Regulatory Support at Gebro Pharma, speaks to Andrea Charles from Pharma IQ, about how new Variations Regulation has impacted eCTD and the key challenges for eCTD lifecycle management. Perschinka also shares his tips for best practice and thoughts on what are the next steps for eCTD.
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Tags:
Hannes Perschinka
eCTD
eCTD Submissions
eCTD Europe
eCTD lifecycle management
EU Variation Regulation
Product Information Management
PIM
Variations Regulation
