2nd eRegulatory Submissions Summit
July 12 - 13, 2018 - Philadelphia PA USExL Events
esternberg@exlevents.com
Phone:917-258-5158
The 2nd eRegulatory Submissions Summit will take place on July 12-13 in Philadelphia, PA, and you will hear experiences from regulatory affair leaders who have adapted, operated and transformed into these regulations successfully. Don’t miss out on two days of reviewing format requirements, staying up to date with the industry, and current trends and challenges on eCTD, RIM, IDMP, and global submissions. Don’t miss out on these featured sessions: . Strategic Planning for Submitting Master Files and Commercial Investigational New Drug Applications in eCTD Format . Regulatory Perspective: Explore How to All Be on the Same Page, Including Vendors . RIM/Records Management: Building Key RIM Partnerships and Changes in Records Policy . EMA Announced the New Location, November 20, 2017, Netherlands — Explore the Impact of the Industry in Light of This Announcement . ANDA, CMC Criterion: Discuss Some of the Enhancements of CMC Filling Requirements in ANDA