Sharing expertise with you in 2012!
February 16, 2012, 12-1:30PM Eastern:
Lee Truax-Bellows will be providing a Compliance2Go webinar entitled
Quality System Approach and Risk Management for Clinical Trials.
Clinical studies continue to fail to meet the minimum regulatory requirements as evidence by regulatory citations that are issued on a fairly consistent basis. What is even more concerning is that these areas of concern remain the same year after year and include inadequacy in; study oversight, protocol compliance, investigational product accountability, training, and IRB/IEC oversight. With all the emphasis on training that many sponsors and investigators put their staff through, the guidance documents issued by the regulatory authorities, continued negative inspections and resulting citations, which in turn result in negative publicity, why does this continue to happen in this day and age? Applying a quality system approach based on risk management will help ensure that industry and their partners, such as third party vendors and site personnel, are better prepared to identify and plan for potential risk areas, plus deal with issues as they arise.
For information or to register, please use this link.
March 8, 2012, 12-1PM Eastern:
Glenda Guest will be providing a Compliance2Go webinar entitled:
The Investigator Agreement: How and When to Complete FDA Form 1572.
There has been long standing confusion and disagreement over who should be listed as a sub-investigator on the 1572. Even experienced clinical investigators continue to struggle with 1572 completion questions and this challenge is further complicated by the growing complexity of clinical trials, which may involve multiple ‘satellite sites’ or distributing other study functions. Learning more about the use of and proper completion of this form will help ensure regulatory compliance with this important document.
For information or to register, please use this link.
May 31, 2012, 12-1:30PM Eastern:
Lee Truax-Bellows will be providing a Compliance2Go webinar entitled:
Preparing for FDA Inspection and Handling the Consequences
We will review the latest inspection statistics released from FDA, discuss how to prepare for an FDA Inspection, discuss how to respond to an FDA Inspection and discuss the possible outcomes of an FDA Inspection that has resulted in significant findings and/or citations.
For information or to register, please use this link.
MedTech Institute Event
Lennox Tech Enterprise Center, West Henrietta, NY
March 13, 2012, 9AM-4PM Eastern
Lee Truax-Bellows will be co-presenting this seminar entitled
Advanced Topics in Good Clinical Practice 2012
This one-day seminar will expand on current issues, changes in industry and new guidance affecting Good Clinical Practice. Participants will gain knowledge in the latest FDA stance on applying GCPs that can be applied to clinical research supporting your product development plans.
For information or to register, please use this link.
Association of Clinical Research Professionals (ACRP)
Global Conference, April 14-17, 2012, Houston, TX, USA
April 16, 2012 at 10:30 AM
Lee Truax-Bellows will be co-presenting session S017 entitled
Overview of Device Clinical Trial Risk Management Models, Including a Six Sigma Case History
With the FDA and industry’s focus of building quality upfront into clinical studies, all device clinical personnel should be familiar with how to apply risk management to their clinical studies. There are many different risk management models that can be applied. This session will provide an overview on several of the better-known risk management models, followed by a case history of the use of the Six Sigma methodology to develop and implement a risk-based model to a company’s clinical program.
April 17, 2012 at 9:15 AM
Glenda Guest and Lee Truax-Bellows are co-presenting session S018 entitled:
Comparative Effectiveness Research: Has the Time Come?
The rising cost of healthcare is forcing governments, healthcare professionals, private insurers, and patients to make hard decisions on what treatments, drugs, and medical devices will be utilized for an individual patient’s healthcare. Comparative effectiveness research is designed to inform healthcare decisions by providing evidence on the effectiveness, benefits, and harms of different treatment options. This session will define comparative effectiveness research, provide the history of how the push came about, and give some recommendations on how to decide when to incorporate such research into the product development plan.
For information or to register for the ACRP Conference, please use this link.
Society of Quality Assurance (SQA) Annual Meeting and Quality College, April 22-27, 2012, Miami, FL, USA
April 25, 2012 at 10:30AM
Glenda Guest and Lee Truax-Bellows are co-presenting a session entitled
Utilizing a Risk-based Approach to Meet Sponsor Monitoring Obligations
In August 2011 FDA released a draft guidance titled “Guidance for Industry; Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring”. Among other points, the guidance discusses the concept of centralized monitoring. While centralized monitoring has never been disallowed, industry has rarely embraced it prior to the release of this guidance. In this session we will discuss applying a risk management approach to the conduct of clinical studies. We will identify what steps to take to assist in determining whether remote source document verification is doable for a given study. We will provide suggestions on how a company can incorporate QA concepts and activities into the assessment, planning and implementation phases of such a project. We will also identify potential QA interactions that will allow the study team to determine if and when they should utilize centralized monitoring and provide tools for the participant to use in making this determination.
April 27, 2012 from 8-5:30
Lee Truax-Bellows will be co-presenting the following Quality College workshop:
Good Clinical Practice: Beyond the Basics
This interactive session will provide experienced GCP QA professionals with additional tools to incorporate into how they perform audits, training and GCP support within their roles. This session has been designed to provide best practices and audience participation activities that highlight the experience of the presenters and the attendees. In addition to these topics, this session will also provide the regulatory perspective as it relates to the current status of GCPs as experienced in the global community.
For information or to register, please use this link.
Model Agreements & Guidelines International (MAGI) Clinical Research Conference 2012 EAST, May 20-23, 2012, Arlington, VA, USA
On May 22 from 2:45-3:30pm Glenda Guest will be presenting a session entitled:
(F406) Electronic Health Records (EHRs) and Clinical Research
On May 22, from 9:30-10:15am Lee Truax-Bellows will be presenting a session entitled
(C350) FDA Inspections: Handling the Consequences
For information or to register, please use this link.
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