Deadline Nears for the Largest Drug Safety Summit Held in the Western U.S.

Emeryville, California (EastBayDaily) — BioSoteria, Inc., Drug Safety and Risk Management Specialists, present the 5th Annual Pacific Drug Safety Summit (PDSS), September 15-16, 2011 at the Hyatt Regency San Francisco Airport, Burlingame, CA.

This year’s conference will offer attendees two full days of coverage on important pharmacovigilance topics as well as numerous networking opportunities. “The speakers at PDSS are internationally renowned and well received by registrants of the conference. Conference attendees love having the opportunity to interact with drug safety industry leaders in an open, collaborative setting. We’re excited to host the largest attended PDSS on its 5th anniversary since inception,” says President and CEO of BioSoteria, Inc., Dr. Sally Van Doren.

With the increasing attention and complexity of pharmacovigilance practice, the conference will take place on two days. The first day will consist of tutorials on a variety of important safety topics. “The response has been overwhelming and tutorial classes on September 15th are filling up quickly.” The second conference day features contemporary drug safety topics presented by national and international thought leaders from companies concerned with drug safety. The attendees will have the opportunity to participate in networking breaks and interact with a diverse gathering of drug safety and pharmacovigilance practitioners from US, EU, and Asia. Interested parties are urged to register before the event sells out. The conference is heavily supported by the generous sponsorships of a dozen or more vendors offering a variety of safety services and products. BioSoteria is an authorized provider of Continuing Education Credits for California Registered Nurses and Pharmacists.

WHERE: Hyatt Regency San Francisco Airport Hotel, Burlingame, CA WHEN: September 15-16, 2011 TO REGISTER: Visit

September 15, 2011 – Featured Tutorials

Applied Safety Signal Detection in Practice Sally Van Doren, PharmD; President & CEO, BioSoteria, Inc.

Practical Approaches to Applying MedDRA in Clinical Safety and Pharmacovigilance Judy Harrison, MD; Senior Medical Officer, MedDRA MSSO

Optimizing Local Affiliate & Partner Participation in the Global PV Process Brad Gallien, Vice President, November Research Group

Efficacy in Serious Adverse Event (SAE) Reconciliation Sean S. Neal, PMP; Principal Consulting, Medidata Solutions

Why and When to Use an Evidence Based Medicine Approach to Drug Safety Charles Schwamlein, MD, MPH; Chief Medical Safety Officer, BioSoteria, Inc.

Practical Signal Detection and Evaluation: An Overview of Epidemiologic Practices Rodney Lemery, MPH, PhD; Senior Director of Safety Management, BioPharm Systems

The Changing Regulatory Environments for REMS and RMPs Branderley Claudio, MD; Associate Director, Safety Physician & Robert Sharrar, MD; Executive Director Safety and Risk Management, United BioSource Corporation

September 16, 2011 – Main Conference Day Featured Topics and Speakers

Leading Pharmacovigilance: A Visionary’s Leap into the Future Keynote Speaker, Hugh Tilson, MD, DrPH; Adjunct Professor of Public Health Leadership, Epidemiology, and Health Policy, UNC Gillings School of Global Public Health

Integrating Clinical and Safety Databases: A Case Study Bethany Van Veen; Sr. Director, Safety Operations, Drug Safety Risk Management, InterMune, Inc.

Evaluating Safety Using Signal Work-Up: How Much Have We Learned? Mary Mease, RPh, MPH; Senior Director, Lifecycle Safety, Quintiles

From Vision to Reality: Considerations for Implementing a Benefit-Risk Assessment James Cross, PhD; Integrated Safety Risk Manager, Genentech

Adverse Event Reporting (AER)-Building and Maintaining A Quality System for Your Contact Center Jeffrey Brandt; Quality Assurance Manager, Rocky Mountain Poison & Drug Center – Denver Health

Update on New EU PV Legislation for 2012: How to Cope Brian Edwards, MD; Principal Consultant in Pharmacovigilance and Drug Safety, NDA Regulatory Science Ltd.

Globalizing Risk Management Plan Activities: Reconciling the Differences Judith Zander, MD; Executive Director, Patient Safety, AstraZeneca

Innovative Governance Model for Product Safety: A Review and Communication Process for Product Safety Lifecycle Management Oliver Steck; Managing Director, PwC

To expand your professional network and find out more about the largest annual drug safety conference in the Western U.S., visit and register today.

About BioSoteria Founded in 2007 with a strong vision of a progressive drug safety and pharmacovigilance consulting services and education, BioSoteria serves the outsourcing needs of the pharmaceutical industry. From strategic risk management consulting services and full-service drug safety operational capabilities to world-class award winning pharmacovigilance training and education programs, BioSoteria provides unmatched experience, expertise, and leadership to support your company’s efforts to maximize your product’s benefit-risk profile. For more information and to learn more about BioSoteria’s drug safety services and training programs, go to


Les Williams
BioSoteria, Inc.