eCTD
Industry View: Consequences of the New Variations Regulation for the ECTD
November 25 by Pharma IQElectronic 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...
eCTD Transforms Pharma
November 08 by Pharma IQEnusring eCTD readiness is now a major concern for all pharmaceutical companies seeking to gain first time approval, as more regulators move towards the eCTD (electronic commo...
Embracing eCTDs and Electronic Submissions
October 20 by Pharma IQIn the past few years, the very way pharmaceutical organisations submit their applications for drug approval has become an essential issue to consider. While paper-based submissions have been a m...
eCTD Rises in Popularity Across Europe
August 09 by Pharma IQAs a growing number of industry authorities confirm that they only intend to accept documents for approval in electronic form, the concept of the electronic common technical document (eCTD) has risen...
What next for PIM and Lifecycle Management?
August 06 by Helen WinsorDr. Andrew Marr, Director of the e-Regulatory Development and Global Regulatory Operations, and Co-Chair of the PIM Steering Committee on behalf of the EFPIA, joins Helen Winsor from Pharma IQ, to d...
Do Electronic Submissions Save Pharmaceutical Companies Time? 62% says Yes!
August 05 by Pharma IQ NewsWith eCTD submissions taking a firm hold in the US and Japan, they are now making their mark in Europe. Now that eCTD submissions are becoming the preferred format for regulatory submissions in Eu...
A Regulatory Perspective: Integrating PIM into the Product Lifecycle
August 01 by Pharma IQHelen Winsor from Pharma IQ, speaks to Dr. Andrew Marr, Director of e-Regulatory Development and Global Regulatory Operations and Co-Chair of the PIM Steering Committee on behalf of the EFPIA. I...
The Successful eCTD Lifecycle Management Series Moves to Eastern Europe
June 22 by Pharma IQ NewsAfter the brilliant feedback from the first Successful eCTD Lifecycle Management conference, that took place in London earlier this year, Pharma IQ is proud to announce the 2nd Successful eCTD Lif...
eCTD Continues Rise to Global Prominence
June 18 by Pharma IQThe ability to meet standards and regulatory approval is nowhere more important than in the pharmaceutical industry. All companies have responsibilities when it comes to submitting information to...
Getting eCTD Submissions Right
June 18 by Pharma IQWhile technology has undoubtedly had an impact on the techniques pharmaceutical firms use to develop new drugs, the digital revolution has also had a major effect on how they meet the number of re...
Are You Prepared for eCTD Submission?
March 28 by Andrea CharlesKlaus Menges, Division of Strategy and Planning, at the Federal Institute for Drugs and Medical Devices, BfArM, joins Pharma IQ, to discuss successful strategies for eCTD submission. To listen...