White Papers

Common Electronic Submission Platform

After public consultation, The European Directorate for the Quality of Medicines & HealthCare (EDQM) has laid down its roadmap for the submission of Certificate of suitability of Monographs of the European Pharmacopoeia (CEP) in electronic format for the next 4 years. This roadmap presents a major change to current practices.

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CDER CBERs eCTD standard format Jan 2017

The Electronic Common Technical Document (eCTD) is CDER/CBER’s standard format for electronic regulatory submissions.Beginning May5, 2017 submission type NDA, ANDA,BLA and Master Files must be submitted in eCTD format.Commercial IND submissions must be submitted in eCTD format beginning May 5, 2018.

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Structured Product Labeling SPL

When discussion takes on to Structured Product Labeling (SPL) often most of our thoughts move to prescribing information. However the US food and drug administration (USFDA) and other regulatory authorities overhaul review procedures, electronic fillings are having a strong effect on the communications.

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Operational Similarities and Differences : USA VS EU

Given the globalization of the biopharma industry, consorting the drug regulatory environs of the United States of America (USA) and European Union (EU) are getting more and more important to fasten the development of new curatives.

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Considerations in RBM Implementation

In this 5th Edition of Applied Clinical Trials' eBook on Risk-Based Monitoring in Clinical Trials, articles cover the advances that have been made in RBM since guidances' released in 2013. How is pharma implementing RBM - is it more remote, centralized or a combination? Read the article by Dr. Ashok Ghone, Vice-President, Global Services at MakroCare:Considerations in RBM Implementation

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