Kowa Research Institute since 2005
Vice President, Regulatory Affairs
BioStratum Inc. 2001 - 2005
Senior Director, Regulatory Affairs
PRA International 2000 - 2001
Vice President, Regulatory Consulting
Delsys Pharmaceutical Corp. 1998 - 2000
Senior Director, Regulatory Affairs
Guilford Pharmaceuticals Inc 1994 - 1997
Vice President, Regulatory Affairs
Education:
MacMurray College 1966 - 1969
BA, Biology
The Johns Hopkins University
MPH, Health Policy and Management
Skills:
Fda Regulatory Affairs Clinical Development Regulatory Submissions Ind Pharmaceutical Industry Regulatory Requirements Drug Development Biotechnology Clinical Trials Gcp Pharmaceutics Glp Cmc Gxp Sop Cro Validation Medical Devices Technology Transfer Commercialization Protocol Drug Discovery Biopharmaceuticals Gmp Immunology Oncology Medical Writing Capa Therapeutic Areas Clinical Research Change Control Ctms Vaccines V&V Lifesciences Pharmacovigilance Regulations Pharmacology Nda Infectious Diseases Ectd 21 Cfr Part 11 Iso 13485 Quality System Ich Gcp Computer System Validation Monoclonal Antibodies Pharmacokinetics Biologics
Youtube
The complicated history of surfing - Scott La...
Today, surfing is a multi-billion-do... global industry, with tens of...
Duration:
5m 40s
EZRA LADERMAN: Bassoon Concerto - Move. II, A...
Happy Birthday to one of America's outstanding composers (born June 29...
Duration:
6m 12s
Mierle Laderman Ukeles - "Who Cares?" Keynote...
"Who Cares?" a virtual keynote presentation from artist Mierle Laderma...
Duration:
1h 43m
Student-Athlete of the Week: Ross Dant
Ross Dant is one of the fastest distance swimmers in the country for h...
Duration:
1m 46s
2001 Freehold Raceway SPICY DIXIE Ross Wolfen...
harness racing.
Duration:
2m 44s
Vermicomposting: How worms can reduce our was...
Nearly one third of our food ends up in the trash can. There is hope, ...