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.

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.

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 www.pacificdrugsafetysummit.com

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 www.pacificdrugsafetysummit.com and register today.