ユーザーIDをお忘れですか? or パスワードをお忘れですか?


Regulatory Affairs: The IND, NDA, and Post-Marketing On-Demand Training

Complete this On-Demand Training Course to learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy.


Elliott  Berger, PhD, MS

Elliott Berger, PhD, MS

President, ETB Regualtory Consulting, United States

Elliott T. Berger, PhD, is President of ETB Regulatory Consulting, LLC. He recently retired from BioCryst Pharmaceuticals, Inc., where he held the position of Senior Vice President of Regulatory Affairs for 14 years. He has frequently served as speaker and session chair at numerous meetings and workshops for DIA and for the Pharmaceutical Research & Manufacturers of America (PhRMA). He serves as an instructor for the DIA Regulatory Affairs: The IND, NDA, and Post-Marketing training course and is a member of the DIA Regulatory Training Committee.

Drusilla  Scott, PhD, RAC

Drusilla Scott, PhD, RAC

Vice President, Regulatory Affairs, Sobi, Inc., United States

Dr. Scott has more than 30 years of experience in drug regulatory affairs in the pharmaceutical industry, and is currently at Sobi, a specialty pharmaceutical company that is building a portfolio of differentiated medicines for patients with rare conditions. She has served in a number of companies, including BDSI, Cempra, EMD, Pfizer and Parke-Davis, as a principal in constructing clinical regulatory strategies and submissions for the development of products across a range of therapeutic areas, with a focus on anti-infective drugs. She is also a certified paralegal with primary interests in administrative law and intellectual property.