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Today is Sep 5, 2010
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| August 18, 2003 |
| Time: |
12:00 PM to 1:30 PM |
| Topic: |
FDA Concept Papers: Risk Management |
| Speaker: |
Sally Van Doren, PharmD |
| Location: |
Gilead Sciences, Inc. |
|
333 Lakeside Drive |
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Foster City, CA, California |
|
Get Map and Directions |
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SALLY VAN DOREN, PharmD
Senior Director, Clinical Research & Medical Affairs
Cerus Corporation
Experience Summary
Over 17 years of pharmaceutical experience, including 10 years of pharmaceutical industry, specializing in:
¨ Medical information services at two pharmaceutical/biotechnology companies
¨ Director of drug safety department clinical and post-marketing safety and institution of a risk management program
¨ Experienced in periodic safety reports, regulatory safety submissions, aggregate safety analysis and signal detection, updating product labeling and core safety information
¨ Establishment of successful procedures for the efficient management of large inquiry volumes following 5 commercial product launches in several therapeutic areas, including antiviral, pain, cardiovascular, womens health
¨ Experience in oral and written communications to health care professionals and consumers
¨ Evaluation and selection of computer technology for safety reporting and medical services
¨ Extensive writing and editorial experience, including regulatory documents for NDA and MAAs, study reports, IBs, aggregate safety reports, educational and sales training materials, slide presentations, posters, abstracts; manuscripts (since 1984)
¨ Promotional material review (product sales materials, press releases, educational programs)
¨ Program leadership in 4 large scale phase IIIb early access programs (over 16,000 patients)
¨ External vendor/CRO bid negotiations, selection, budgeting, project management
¨ Fiscally responsible - projects run within budget (as high as $11 million per project)
¨ Extensive public speaking experience, including internal and external venues
¨ Knowledge in worldwide drug safety regulations, risk assessment, drug product labeling
¨ Well versed in ICH, GCP, CIOMS, FDA and EU regulations and guidance documents
¨ Development of SOPs for clinical research, medical information, and safety
¨ Conduct and implementation of hospital and clinic based drug utilization evaluation studies
¨ Transcultural educational program development to multinational medical staff
¨ Clinical pharmacy practice experience in 3 leading tertiary care hospitals with emphasis in infectious diseases, general medicine, oncology, and organ/bone marrow transplantation.
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