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Profit - Hot 50Xtalks is part of Honeycomb Worldwide Inc., recognised by Profit Magazine as one of Canada's Hot 50 emerging companies in 2006.

Xtalks is a web-based news and information network that provides timely insight on a variety of issues through regular, interactive digital presentations with industry experts and business leaders.

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Jan-30

Optimizing Clinical Supplies When Facing Drug and Resource Constraints

LifeScience
Feb-1

Companion Diagnostics: Case Studies in Managing Risk and Cost

LifeScience
Feb-7

The FDA Animal Rule – Successful Submission of Animal Efficacy Studies

LifeScience
Feb-8

Applied Drug Delivery: Hot Melt Extrusion and Optidose Technology

LifeScience
Feb-14

Perspectives on Pediatric Trials from Investigative Sites

LifeScience
Feb-28

Successful Introduction of GLP-compliant Reproductive Toxicology Programs

LifeScience
Mar-12

International Real World Post-marketing Studies that Involve Patient Intervention

LifeScience
Mar-13

Russia: Understanding the Regulatory Environment, Challenges & Benefits

LifeScience
Mar-20

Simulation Modeling for Optimizing Design of Clinical Trials and Registries

Healthcare
Mar-21

Risk Management of Adventitious Agent Contamination in Biopharmaceutical Products

LifeScience
Mar-22

Comprehensive Sample Management: Leveraging an Onsite Model to Maximize Research and Minimize Costs

LifeScience
Mar-27

Madrid: Hub for North American and Latin American IT/ICT Companies in Europe

BusStrategy
Apr-4

EU Pharmacovigilance Change Readiness 2012

LifeScience

Spotlight On:

Safety Reporting to the Institutional Review Board (IRB): Understanding Recent Guidance

Complimentary On Demand Archive available today

Keynote Speaker:

- Glenn Veit, JD, CIP, Chairperson, Copernicus Group IRB

Reduce the reporting burden on sites, sponsors, CROs and review boards while raising the bar on providing meaningful protection of the subjects participating in clinical trials.

Responsibility
Clinical research involves a shared responsibility among sponsors, CROs, investigators and institutional review boards (IRBs) to safeguard the rights, safety and welfare of human subjects.

Impact
A major component of this shared obligation is the meaningful review and communication among the clinical trial stakeholders of new safety information that may develop during the trial. Multiple federal guidance documents have been issued over the past few years to assist the research community with interpreting the regulations. The intent of the new guidance was to respond to concerns among IRBs, and others, that an overwhelming number of reports were inhibiting, rather than enhancing the protection of human subjects…but, has anything changed?

Goals
This presentation is to bring clarity to the recent guidance and describe an effective approach to safety reporting for sponsors, CROs and investigative sites. Ultimately, the goal is to reduce the burden on sites, sponsors, CROs and review boards while raising the bar on providing meaningful protection of the subjects participating in clinical trials.

This program will help you put the guidance into action in the following ways:

  • Identify responsibilities of each stakeholder
  • Identify what events must be reported to the IRB
  • How best to report safety information events
  • What information the IRB needs to conduct a thorough review

For more information or click on Register Today to access the Complimentary On Demand archive:

Register

 
   
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