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8th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR

Philadelphia, USA

Joel Finkle

Joel Finkle


Title: A personal history of regulatory submissions technology


Biography: Joel Finkle


Regulatory submissions today fall under pretty strict standards: If it isn’t an eCTD (electronic Common Technical Document) it’s still likely to be based on the CTD, whether it’s electronic or not. Harken back to the days when publishing involved custom software; where a submission could mean shipping 150 pounds of equipment, or transporting multiple laptops across international boundaries; where reviewer demands could involve a 6AM phone call and a 7AM plane ticket. But it wasn’t all bad: the early days of electronic submissions resulted in an unprecedented level of interaction between reviewers and
regulatory and led to our modern standards.