Industry View: Consequences of the New Variations Regulation for the ECTD

Hosted By: Pharma IQ
11/24/2010
Rate this Podcast: 
Be the first!
To continue viewing this content please fill out the form below and become an Pharma IQ member.
Or if you're already a Pharma IQ member, sign in below to download.
Join

By entering in your information and submitting the form, you give the sponsor permission to contact you regarding their product and you agree to our User Agreement, Privacy Policy, and Cookie Policy.

About this Podcast...

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. 

EVENTS OF INTEREST

Crowne Plaza Zurich, Zurich, Switzerland
June 17 - 19, 2018