Best Practice Tips for Successful eCTD Submissions
Add bookmark
Best Practice Tips for Successful eCTD Submissions
Add bookmark
Yann Kervevan, EMEA Regulatory Affairs Operations Manager, Alexion Pharmaceuticals, joins Helen Winsor from Pharma IQ, to dicsuss the challenges in eCTD implementation and electronic submissions.
Firstly Kervevan offers some best practice tips for industry on converting and assembling files. He reflects on what he considers the most effective ways to implement quality control, content and technical validation of eCTD submissions and offers some advice to companies on managing submission timelines and regulatory expectations. Finally, he discusses the main coding challenges when transferring data from eCTD to regulatory platforms and how can these be overcome.
[inlinead]
Tags:
Yann Kervevan
Alexion Pharmaceuticals
eCTD Submissions
electronic submissions
eCTD regulatory platforms
validation eCTD submissions
