September Conference to Draw Global Biopharmaceutical Drug Safety Decision-Makers to San Francisco

Emeryville, CA (PRWEB) February 28, 2012, BioSoteria, Inc., Drug Safety and Risk Management Specialists, and organizers of the Annual Pacific Drug Safety Summit (PDSS), launched the PDSS website and has opened the invitation for abstract submission for an oral presentation during the main conference or corporate sponsor pre-conference tutorial at the 6th Annual PDSS. The conference will be held on September 20-21, 2012 at the Hilton San Francisco Airport Bayfront, Burlingame, CA. Sponsored pre-conference tutorials will be held on September 20, 2012 and oral presentations will take place during the main conference day on September 21, 2012. Speakers are encouraged to submit an abstract based on their work in the area of pharmacovigilance, risk management and/or pharmacoepidemiology

PDSS is one of the leading and fastest growing annual drug safety and pharmacovigilance conferences in the United States, drawing participants from US, Europe and Asia and annually held in San Francisco, home to a thriving pharmaceutical and biotechnology industry with the largest cluster of life sciences companies in the United States.

TOPICS PREVIOUSLY ADDRESSED AT PAST PDSS CONFERENCES INCLUDE: 
RMP/REMS assessments and effective risk minimization tools 
Solutions for streamlining Safety Operations 
New or upcoming changes in US and EU regulations in pharmacovigilance compliance and inspections 
Pharmacoepidemiology practice and applied study designs in pharmacovigilance 
Safety signal detection methods and practical approaches 
Other topics relevant to a pharmacovigilance and a drug safety industry practice audience

PAST SPEAKERS: 
Hugh Tilson, MD, DrPH, Adjunct Professor of Public Health Leadership, Epidemiology, and Health Policy, UNC Gillings School of Global Public Health 
Rebecca Wang, MD, Head of Drug Safety, Roche Global Pharma Development Center, China 
Valerie Simmons, MD, BS, FFPM, Lilly QPPV Executive, Global Patient Safety, Eli Lilly & Co Ltd, UK 
James Cross, PHD; Integrated Safety Risk Manager, Genentech 
Judith Zander, MD; Executive Director, Patient Safety, AstraZeneca 
Paul Coplan, Sc.D, MBA, Senior Director, Risk Management, Global Safety Surveillance and Epidemiology, Wyeth Pharmaceuticals 
Robin Geller, PhD; Director of Risk Management, Global Pharmacovigilance, Baxter Healthcare Corporation 
Catherine Hardalo, MD, VP, Clinical Development, Cadence Pharmaceuticals 
Tobias Peschel, MD, PhD, MBA, VP, Drug Safety & Public Health, Gilead Sciences 
Bethany Van Veen, Director, Safety Operations Drug Safety Risk Management, InterMune, Inc. 
Eleanor Segal, MD, VP, Medical Safety Officer, Actelion Pharmaceuticals Ltd. 
Gregory M. Bogdan, PhD, Research Director—RADARS®, Rocky Mountain Poison & Drug Center—Denver Health 
Julie Acquafredda, MBA, Senior Project Manager PV, Takeda Global R&D 
Cathy Sigler, DVM, PhD; Sr. Director, Safety, Epidemiology, Registries & Risk Management, United Biosource Corporation 
Mary Mease, RPH, MPH, Senior Director Medical Affairs, Epidemiology & Outcomes Research, Quintiles 
Brian Edwards, MD; Principal Consultant in Pharmacovigilance and Drug Safety, NDA Regulatory Science Ltd.

“PDSS has grown to become one of the most well attended drug safety conferences held in the US. Our speakers and attendees have represented over 50 pharmaceutical, biotechnology, medical device companies as well as vendors and service providers from around the globe, sharing diverse practices and challenges facing drug safety professionals in today’s dynamic regulatory environment. Our networking sessions and practical approach to our Program Committees’ selected topics and speakers have been winning elements in the success of PDSS. We invite you to participate by expressing your interest in an oral presentation by submitting an abstract to the PDSS website.” – Sally Van Doren, PharmD, President and Chief Executive Officer, BioSoteria, Inc.

Those interested in an oral presentation during the main conference day may submit an abstract for consideration by the PDSS Program Committee at http://www.PacificDrugSafetySummit.com

For those corporate sponsors who wish to host a pre-conference tutorial, please go to http://www.PacificDrugSafetySummit.com to register your sponsorship.

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

EDUCATIONAL OPPORTUNITIES

The Fourth Annual Pacific Drug Safety Summit (PDSS) will take place September 23-24, 2010 at the San Francisco Airport Marriott in Burlingame, CA.

BioSoteria, Inc., Drug Safety and Risk Management Specialists, present the Fourth Annual Pacific Drug Safety Summit, September 23-24 at the San Francisco Airport Marriott Hotel, Burlingame, CA. “This year's PDSS will be the largest conference attended with two days of contemporary pharmacovigilance topics" says President and CEO of BioSoteria, Inc, Dr. Sally Van Doren.

“With the increasing attention and complexity of pharmacovigilance practice, we have extended the conference by adding an additional day of tutorials on a variety of important safety topics. The response has been overwhelming and tutorials are filling quickly.” Interested parties are urged to register before the event sells out. The two day conference features six pre-conference tutorials on day one, while the second day features nine 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 US and EU drug safety and pharmacovigilance practitioners, service providers, and vendors from around the globe. The possibility of Continuing Education Credits for California Registered Nurses and Pharmacists is pending approval. Breakfast and lunch will be served. This event is conveniently close to the heart of biopharmaceutical companies in the Bay Area, the airport, and public transportation.

WHERE: San Francisco Airport Marriott Hotel, Burlingame, CA
WHEN: September 23-24, 2010
TO REGISTER: Visit www.pacificdrugsafetysummit.com

September 23, 2010 - Featured Tutorials

• Hosted Application Solutions for Pharmacovigilance
  Wade Weinzetl, Senior Director of Safety Systems, Sentrx
  
  
• Good Pharmacovigilance Practices During Clinical Trials
  James Buchanan, PharmD, Senior VP, Pharmacovigilance and Risk Management, BioSoteria, Inc.
  
  
• Safety Monitoring and Reporting for Products Operating Under a REMS With ETASU
  Wenda K. Brennan, R. Ph., Director Pharmacovigilance
  Catherine Sigler DVM, MPH, PhD, Senior Epidemiologist, Safety, Epidemiology, Registries & Risk
  Management Group, United BioSource Corporation
  
  
• Good Pharmacovigilance Practices Postmarketing
  Sally Van Doren, PharmD, President and CEO, BioSoteria, Inc.
  
  
• Risk Evaluation and Mitigation Strategies (REMS)
  An Overview of Current Regulations and Approach to Documentation and Preparation
  Mark Loudon, Director of Regulatory Compliance, Aris Global
  Dr. Jacinta Aniagolu-Johnson, Director, PV & Risk Management, Synowledge (an Aris Global affiliate)
  
  
• Global PV Compliance Monitoring and CAPA Management
  An Overview and Case Study on How to Efficiently Monitor, Improve and Sustain ICSR Compliance
  Vladimir Laguerre, Partner, Foresight Group International
  Brian Dinardo, Partner, Foresight Group International

September 24, 2010 – Featured Topicsand Speakers

• The Changing EU Pharmacovigilance Landscape
  ValerieSimmons, MB BS FFPM
  Lilly QPPV Executive, Global Patient Safety,
  Eli Lilly & Co Ltd., UK
  
  
• The Sentinel Initiative and Healthcare Database Outcomes Research Moving Pharmacovigilance in a New Direction?
  Mary Mease, RPH, MPH
  Sr.Dir.Medical Affairs,Epidemiology & Outcomes Research
  Quintiles
  
  
• Signal Detection and Evaluation of Drug-Induced Hepatotoxicity
  Catherine Hardalo, MD
  VicePresident, Clinical Development
  Cadence Pharmaceuticals
  
  
• Coping with the Changing Demands on a Drug Safety Department
  TobiasPeschel, MD, PhD, MBA
  Vice President, Drug Safety & Public Health
  Gilead Sciences
  
  
• Successfully Navigating a Pre-Approval Inspection from a Drug Safety Perspective
  Bethany VanVeen
  Director,Safety Operations Drug Safety Risk Management
  InterMune, Inc.
  
  
• REMS Case Study: One Company's Experience
  Eleanor Segal, MD
  VicePresident, Medical Safety Officer
  Actelion Pharmaceuticals Ltd.
  
  
• REMS Assessments: A Description of a Busy First Yearof Kab Surveys
  Catherine Sigler DVM, MPH, PhD,
  Senior Epidemiologist, Safety,Epidemiology,Registries & Risk Management Group United BioSource Corporation
  
  
• A Framework for Opioid REMS Assessment
  Gregory M. Bogdan, PhD
  Research Director -RADARS® System
  Rocky Mountain Poison & Drug Center -Denver Health
  
• Forming a PV Regional Professional Network
  Julie Acquafredda,
  MBA Senior Project Manager PV
  TakedaGlobal R&D

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.

For more information regarding the conference

Oral poster presentation: Evaluation of US Package Inserts Following the Physician Labeling Rule
James Buchanan, PharmD, Sr. Vice President Pharmacovigilance and Risk Management and Sally Van Doren, PharmD, President & CEO, BioSoteria, Inc.

Background: FDA issued a guidance document entitled Adverse Reactions (AR) Section Labeling for Human Prescription Drug and Biological Products and Format in January 2006. This guidance is intended to assist both applicants and reviewers in drafting the AR section of the prescribing information in the new format specified by the new labeling rule.

Objectives: To determine if new or updated US package inserts released after January 2006 FDA guidance, follow the new labeling rule with regard to threshold and criteria for AR inclusion in product labeling.

Methods: Drug products with new or updated US package inserts after January 2006 through December 2007, were identified by a search of the FDA website; only those in the new labeling format were further evaluated. The clinical safety AR sections was reviewed to determine if the FDA guidance criteria and thresholds for AR inclusion were followed.

Results: Thirteen US package inserts were identified in the updated labeling format. Clinical trial AR tables were selective in those ARs included. The use of a threshold event rates was common with all labels; however, different thresholds were used across labels. Labeling was found to be inconsistent in approach for inclusion of ARs with higher incidence compared to placebo. There was even greater variability in AR inclusion when treatment groups compared to active comparator.

Conclusions: The review of recently updated US Package inserts following the FDA new labeling rule indicates that many, but not all, of the guidance concepts are being applied with regard to AR inclusion and display. It is anticipated as both FDA reviewers and marketing applicants become more familiar with this new process, that the resulting labels will more closely match the intent and direction of the guidance document.

BioSoteria President and Chief Executive Officer Sally Van Doren will chair a session on drug safety signal detection at the 46th DIA Annual Meeting next week in Washington, DC.