- Posted on:
Thursday, 12 January 2012 22:34
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UPCOMING EVENTS
January 22-25, 2012
Meet us at the DIA Pharmacovigilance and Risk Management Strategies 2012, Sheraton National Hotel, Arlington, VA
Web Link
June 24-28, 2012
DIA 2012: Collaborate to Innovate
Meet us at the 48th Annual DIA Meeting, Pennsylvania Convention Center, Philadelphia, PA
Web Link
September 21-22, 2012 SAVE THE DATE!
Sixth Annual Pacific Drug Safety Summit
Hilton, San Francisco Airport Bayfront, Burlingame, CA
Web Link Updated Website Coming Soon!
EDUCATIONAL OPPORTUNITIES
January 22, 2012, 8:30 AM - 12:00 PM ET
Signal Detection, Case Assessment and Data Mining in Pharmacovigilance: Current State of the Art ($)
Tutorial Leaders: Sally Van Doren, PharmD, President & CEO, BioSoteria, Inc.
Sheila Weiss Smith, PhD,MS,FISPE, Professor; Director, Center for Drug Safety, University of Maryland School of Pharmacy
DIA Pharmacovigilance and Risk Management Strategies, Sheraton National Hotel, Arlington, VA
Web Link
February 14, 2012, 9:00 AM PT
Practical Aspects of Signal Evaluation – Clinical Development (FREE)
Webinar Leader: James Buchanan, PharmD, Senior Vice President, Pharmacovigilance and Risk Management, BioSoteria, Inc.
Web Link
March 13, 2012, 9:00 AM PT
Practical Aspects of Signal Evaluation – Post-Marketing (FREE)
Webinar Leader: James Buchanan, PharmD, Senior Vice President, Pharmacovigilance and Risk Management, BioSoteria, Inc.
Web Link
June 24-28, 2012 Track 14 (Clinical Safety and Pharmacovigilance)
REMS: Are Our Written Communications Truly Mitigating Risks to Patients? ($)
Session Chair: Sally Van Doren, PharmD, President & CEO, BioSoteria, Inc.
DIA 2012: Collaborate to Innovate - 48th Annual DIA Meeting, Pennsylvania Convention Center, Philadelphia, PA
Web Link
June 24-28, 2012 Track 19 (Clinical Safety and Pharmacovigilance SIAC)
Good Pharmacovigilance Practices in a Global Environment ($)
Tutorial Leader: Sally Van Doren, PharmD, President & CEO, BioSoteria, Inc.
DIA 2012: Collaborate to Innovate - 48th Annual DIA Meeting, Pennsylvania Convention Center, Philadelphia, PA
Web Link
October 1, 2, 8 and 9, 2012, 12:00 PM ET - 1:30 PM ET
Introduction to Signal Detection and Data Mining ($)
Four part webinar series
Webinar Leader: Sally Van Doren, PharmD, President and CEO, BioSoteria, Inc.
Drug Information Association
Web Link |
- Posted on:
Tuesday, 13 December 2011 00:00
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Emeryville, CA (PRWEB) December 13, 2011 -- BioSoteria, Inc., Drug Safety and Risk Management Specialists, announced today that its President and Chief Executive Officer, Sally Van Doren, PharmD, will co- instruct the tutorial, "Signal Detection, Case Assessment and Data Mining in Pharmacovigilance: Current State of the Art” with Sheila Weiss Smith, PhD, MS, FISPE, Professor of pharmaceutical health services research at University of Maryland School of Pharmacy. The tutorial is part of the Drug Information Association’s (DIA) Pharmacovigilance and Risk Management conference to be held at the Sheraton National Hotel in Arlington. The tutorial will be offered on Sunday, January 22, 2012, 8:30 AM - 12:00 PM. The tutorial will focus on application of data mining techniques to safety surveillance and signal detection and the critical role of clinical case and case series assessment. “The increased focus on the safety of drugs and biologics and volume of safety data creates a need for objective quantitative approaches to supplement the medical review of individual case safety reports”, says Dr. Van Doren. “This course is designed to be a practical, hands-on tutorial so participants can easily apply the principles of signal detection and data mining in their own practices”.
BioSoteria will also exhibit during the conference, Monday, January 23 - Thursday, January 25, 2012, 8:00 AM– 5:00 PM. The Sheraton National Hotel located at 900 South Orme Street, Arlington, VA.
About DIA
DIA is a neutral, nonprofit, global, professional association of nearly 18,000 members who work in every facet of the discovery, development, and life cycle management of pharmaceuticals, medical devices, and related products. |
- Posted on:
Thursday, 20 October 2011 00:00
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BioSoteria President and CEO, Sally Van Doren, PharmD, will be a Keynote Speaker at the 4th Annual China Drug Safety & Public Summit, October 26-27, 2011 in Shanghai, China.
Emeryville, CA (PRWEB) October 20, 2011 -- BioSoteria, Inc., Drug Safety and Risk Management Specialists, announced today that its President and CEO, Sally Van Doren, PharmD, will be a Keynote Speaker at the 4th Annual China Drug Safety & Public Summit.
“Drug safety and postmarketing surveillance have become important public health issues in China”, says Dr. Van Doren. “The rapid development of drug safety surveillance in China is manifested in extensive organizational structure, development of large databases, and laws and regulations supporting drug safety. My keynote presentation will address lessons learned in the US risk management programs (RMPs) as they may apply to RMPs in China in future.”
The keynote presentation is entitled- “Risk Management Plans: Is there Evidence that Risk Communication Strategies Reduce Patient Risk?”, and will take place on October 27, 2011 at the Crowne Plaza Century Park Hotel in Pudong Shanghai, China. |
- Posted on:
Tuesday, 11 October 2011 00:00
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BioSoteria Senior Vice President, Pharmacovigilance and Risk Management, James Buchanan will chair a session “Safety In Clinical Trials” at the 2011 RAPS: Regulatory Convergence, October 25, 2011 in Indianapolis
BioSoteria, Inc., Drug Safety and Risk Management Specialists, announced today that its Senior Vice President, Pharmacovigilance and Risk Management, James Buchanan, PharmD will chair a 90 minute session called “Safety In Clinical Trials.”
The session will cover the FDA final regulations addressing the safety reporting requirements for investigational new drug applications and its impact on a clinical development programs, regulatory and clinical expectations of expectedness and safety surveillance and risk management for medical device clinical studies. The presentation will take place at the 2011 RAPS: Regulatory Convergence on October 25, 2011 from 8:30-10:00 AM at the Indianapolis, Indiana Convention Center.
To register for the session and to find out more about the 2011 Raps: Regulatory Convergence, go to www.raps.org. |
- Posted on:
Thursday, 22 September 2011 00:00
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Emeryville, CA (PRWEB) September 22, 2011 -- BioSoteria, Inc., Drug Safety and Risk Management Specialists, supports the important work of the UCSF AIDS Health Project by creating an important public service announcement for the organization. The AIDS Health Project, founded in 1984, is one of the oldest AIDS service organizations in the United States. Ranked among the best AIDS programs in the U.S., AHP is a program of the Department of Psychiatry of the University of California San Francisco and is affiliated with San Francisco General Hospital.
“The mission of the UCSF AIDS Health Project is to provide culturally sensitive counseling and education to stop the spread of HIV infection, and to help people face the emotional, psychological and social challenges of living with HIV disease,” says President and CEO of BioSoteria, Inc., Dr. Sally Van Doren. “We are excited to work with AHP for a seventh year and to support their important work.”
This year BioSoteria will be a Silver Sponsor for Art for AIDS benefitting the USCF AIDS Health Project. The event will take place September 23, 2011 at the San Francisco Design Center in the Galleria. To find out more about Art for Aids and the USCF AIDS Health Project go to http://www.ucsf-ahp.org/ |
- Posted on:
Friday, 09 September 2011 00:00
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Emeryville, CA (PRWEB) September 09, 2011 -- BioSoteria, Inc., Drug Safety and Risk Management Specialists, announced today that “Success Factors for Implementing an EDC to Safety System Data Interface,” has been just added to the tutorial line-up at the Pacific Drug Safety Summit. The tutorial is sponsored and presented by Medidata and will take place Thursday, September 15, 2011 at the Hyatt Regency, San Francisco Airport.
The tutorial will discuss the challenges of handling paper SAE case forms and the success factors to consider when implementing an electronic method of processing data from EDC to Safety Systems. Reporting serious safety events to regulatory bodies in a timely manner during the course of a clinical study is critical for sponsors. But in today’s paper and fax based practices, to collect serious adverse event (SAE) case information from investigational sites and then manually entering it into safety reporting systems, are costly, laborious and inefficient. EDC to safety system electronic data interfaces are innovative solutions that pave the way to a more efficient and accurate process for collecting and communicating SAEs and related data; and achieve greater reconciliation efficacy. The tutorial will focus on leveraging a data interface from EDC to a safety system to:
- Eliminate redundant safety data entry
- Increase productivity
- Speed the processing time of cases and
- Reduce reconciliation between the two systems.
The Fifth Annual Pacific Drug Safety (PDSS) will take place September 15-16, 2011 at the Hyatt Regency San Francisco Airport in Burlingame, CA. BioSoteria is an authorized provider of Continuing Education Credits for California Registered Nurses and Pharmacists. To register for this newly added tutorial and more information on the Pacific Drug Safety Summit, go to www.PacificDrugSafetySummit.com.
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