Hope He joined Keller and Heckman in 2011. She practices in the area of food and drug law.
Before joining Keller and Heckman, Ms. He directed the Human Research Subjects Protection Program for a hospital in the U.S., managing its Institutional Review Board and Privacy Board. She also managed the hospital's Center for Pediatric Clinical Research and developed the hospital's research integrity and conflicts of interest policies and procedures. Prior to that, Ms. He led and worked closely with teams of drug and device regulatory professionals providing clients with hands-on regulatory support, including preparation, assembling, critical review and submission of U.S. Food and Drug Administration (FDA) drug and device applications, reports, and other related documentation, and development and implementation of pharmaceutical product development strategies.
Ms. He's diverse work experience has helped her gain expertise in FDA and DHHS regulations governing human research (clinical research) and patient privacy, including relevant ICH guidelines and the HIPAA Privacy Rule.
Born and raised in China, and educated in China, Canada and the U.S., Ms. He is fluent in Chinese Mandarin, in addition to English.
Memberships
Regulatory Affairs Professionals Society
News, Events & Articles
Articles
Jun 30, 2011, China New Food Safety National Standards - Standards for Use of Food Additives (GB 2760-2011)
Apr 19, 2011, State Council of China Announces Revised Regulation on Control Over Safety of Dangerous Chemicals
Mar 29, 2010, China Promulgates Revised Environmental Administration Provisions for New Chemical Substances
Mar 15, 2010, Regulation and Clearance Procedures for Food Packaging Materials in the People's Republic of China