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Welcome and Introduction
Session Chair(s)
Drusilla Scott, PhD, RAC
Vice President, Regulatory Affairs
Sobi, Inc., United States
Welcome and Introduction
Seaport Hotel
2019 年 08 月 12 日 7:45 上午 - 2019 年 08 月 15 日 5:00 下午
One Seaport Lane, Boston, MA 02210
Regulatory Affairs: The IND, NDA, and Post-Marketing
Learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy.