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« Tuesday August 10, 2010 »
Tue
Defining and Managing Protocol Deviation/Violation/Exception Start: 08/10/2010 10:00 am End: 08/10/2010 10:00 am In this GCP Webinar training, learn how to proactively predict and manage Protocol Deviation/Violation/Exception. Understand the guidance for implementation of “Protocol Not Followed” (PNF). Why Should You Attend: As the purpose of a clinical trial is to determine safety and effectiveness of a treatment, it is imperative that the rules of the trial be followed exactly. If there are Instances of “Protocol Not Followed” (PNF), that could result in a failure to determine safety and effectiveness. That is why eligibility criteria are so strict, and why any PNF or unexpected events need to be reported immediately. Principal investigators in clinical trials are expected to adhere to the study protocol. Instances of “Protocol Not Followed” (PNF) are not addressed in the CFR or other regulatory rules. The various terms used to describe PNF (violation, deviation, and exception) are open to different interpretations by the parties involved. Areas Covered in the Seminar: How to define and manage Protocol Deviation/Violation/Exception. Proactive approaches to predict and prevent clinical trial protocol violations. Industry and FDA perspectives on Protocol Deviation/Violation/Exception. Discuss the current lack of unified definition for protocol deviation/violation/ exception. Define the term “Protocol Not Followed” (PNF). Explain the guidelines for the implementation of PNF to include capturing, reporting, and documentation. Review recent noncompliance trends and regulatory focus for Sites, Sponsors, and IRBs. Changes in US FDA Enforcement Start: 08/10/2010 10:00 am End: 08/10/2010 11:30 am This FDA Compliance training will discussion on major changes in FDA enforcement and how the regulated industry should respond to any FDA inspection activity. Why Should You Attend: In the first major changes in FDA enforcement in 20 years the US FDA has increased its level of regulatory oversight of regulated industries.From a new Commissioner to additional inspection and pre-market resources the FDA is increasing oversight. While FDA insists that it continues to support innovation in medical products, its primary publicity is in enforcement with an active program to improve its image through increased publicity of enforcement activities and public information on recalls and product risks. Areas Covered in the Seminar : Pressures on FDA. FDA Re-organization. FDA changes in focus. New Enforcement Resources. What industry should expect of FDA. FDA expectations for responses to FDA-483 observations. FDA expectations for responses to Warning Letters. Note: Use this Promo Code(102040) to avail Discount of 10% on LIVE Purchase. Upcoming Webinar: Best Practices and Proven Techniques for Application Portfolio Management Start: 08/10/2010 11:00 am End: 08/10/2010 12:00 pm In this webinar you get to learn what APM is all about and focus on what best practices can be adopted to determine the next stage for the legacy application and the data it has. The session would also delve into the details of retiring or decommissioning the legacy applications and maintain the data from compliance and eDiscovery point of view. If you are interested do register. Webinar is scheduled on Tuesday, Aug 10, 11:00 am - 12:00 pm (PST). Peter Shankman's Social Media Video Secrets Start: 08/10/2010 7:12 pm Join us for this live video webinar on how to grow your business by using video. Social media expert and founder of Help A Reporter Out (HARO) Peter Shankman will share his secrets on how to: - tell your story in a compelling way on video - leverage social media videos to get the word out - get press attention for your video We'll be showing plenty of examples and also be giving two selected business videos a 'video makeover'.