Best Practice Tips for Successful eCTD Submissions
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 tim...
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