is being presented by Andres Heuberger, President, of ForeignExchange Translations, and airs on Thursday, June 24th, 2010. For more details or to register, please visit our site at www.fxconferences.com
It's challenging enough for manufacturers to deal with evolving EU regulations, never mind that your head is spinning from coordinating the reviews of multiple translated components in numerous countries!
Internal politics, miscommunication across time zones, and vacation schedules can make translation reviews an expensive and time-consuming process. Rather than shifting responsibility overseas or skipping reviews altogether, attend this advanced audio conference.
With proper planning, open communication, and strong vendor relationships, it is possible to reduce turnaround time, keep translation costs manageable and even avoid a few headaches. This presentation shows you how.
Monday, May 17, 2010
Friday, May 14, 2010
How to Avoid GCP Non-Compliance Issues in Your Clinical Trials
is being presented by Dr. Howard Hubbell, President, of Hubbell Consulting, LLC and airs on Tuesday, June 22nd, 2010. For more details or to register please visit our site at www.fxconferences.com
Good Clinical Practice (GCP) is a set of ethical and operational principles which assure that the conduct of clinical trials and the data derived from those trials protect the participating human subjects and assure the quality, reliability and integrity of the clinical data. Because of the complexity of clinical trials, multiple personnel in the trial process have responsibilities for maintaining GCP compliance. However, in many instances, clinical trials are GCP non-compliant in at least one component of the study, at some point during the study. Depending on the non-compliant issues, GCP non-compliance can potentially lead to warning letters, suspension of the trial or rejection of some or all of the trial data by regulatory agencies.
In this audio conference, the speaker defines GCP, outlines the roles of those working on various aspects of the clinical trial (including sponsors, investigators, CROs, monitors and IRBs) and describes the documents necessary for performing a clinical trial. In addition, regulatory inspections and audits of clinical trials are discussed, along with common GCP non-compliance findings and resultant regulatory actions. Strategies and actions will be presented for maintaining GCP compliance.
Good Clinical Practice (GCP) is a set of ethical and operational principles which assure that the conduct of clinical trials and the data derived from those trials protect the participating human subjects and assure the quality, reliability and integrity of the clinical data. Because of the complexity of clinical trials, multiple personnel in the trial process have responsibilities for maintaining GCP compliance. However, in many instances, clinical trials are GCP non-compliant in at least one component of the study, at some point during the study. Depending on the non-compliant issues, GCP non-compliance can potentially lead to warning letters, suspension of the trial or rejection of some or all of the trial data by regulatory agencies.
In this audio conference, the speaker defines GCP, outlines the roles of those working on various aspects of the clinical trial (including sponsors, investigators, CROs, monitors and IRBs) and describes the documents necessary for performing a clinical trial. In addition, regulatory inspections and audits of clinical trials are discussed, along with common GCP non-compliance findings and resultant regulatory actions. Strategies and actions will be presented for maintaining GCP compliance.
Thursday, May 13, 2010
Complying with Breach Notification Provisions of the HITECH Act
is being presented by Kate Borten, President, of The Marblehead Group and airs on Thursday, June 17th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
The HITECH Act’s requirement for breach notification is the first national law – and the most sweeping – to call for the notification of individuals whose Protected Health Information (PHI) has been breached. The law and subsequent HHS rule are enforceable now, and organizations that incur a breach and fail to fulfill all of the standards are subject to both state and federal penalties.
This audio conference summarizes the breach notification requirements under the HITECH Act, highlighting areas that are particularly challenging for organizations, such as defining incidents and determining harm. It explains how breach notification steps fit into the mandated incident response plan and the need for proactive planning. Additionally, the speaker draws upon several real-life case studies to highlight important lessons learned.
The HITECH Act’s requirement for breach notification is the first national law – and the most sweeping – to call for the notification of individuals whose Protected Health Information (PHI) has been breached. The law and subsequent HHS rule are enforceable now, and organizations that incur a breach and fail to fulfill all of the standards are subject to both state and federal penalties.
This audio conference summarizes the breach notification requirements under the HITECH Act, highlighting areas that are particularly challenging for organizations, such as defining incidents and determining harm. It explains how breach notification steps fit into the mandated incident response plan and the need for proactive planning. Additionally, the speaker draws upon several real-life case studies to highlight important lessons learned.
Wednesday, May 12, 2010
CGMP Guidance for Phase 1 Clinical Supplies
is being presented by Marion Weinreb, President, of Marion Weinreb & Associates, Inc. and airs on Tuesday, June 15th, 2010. For more details or to register please visit our site at www.fxconferences.com
The new FDA guidance document for Phase 1 clinical supplies is significant because it will enable companies (large and small) to move faster through their clinical manufacturing process, while not being bogged down with complying with all aspects of 21CFR Part 211. FDA realized that the CGMPs should not have been enforced for Phase 1 clinical supplies. This guidance document focuses primarily on controls that prevent adulteration and misbranding of the Phase 1 clinical supplies. It allows flexibility in implementing the controls needed to achieve those goals. In this audio conference, our speaker reviews the guidelines, identifies the types of SOPs and controls that are needed, and identifies for the virtual company, what types of SOPs are needed to deal with vendor relationships.
The new FDA guidance document for Phase 1 clinical supplies is significant because it will enable companies (large and small) to move faster through their clinical manufacturing process, while not being bogged down with complying with all aspects of 21CFR Part 211. FDA realized that the CGMPs should not have been enforced for Phase 1 clinical supplies. This guidance document focuses primarily on controls that prevent adulteration and misbranding of the Phase 1 clinical supplies. It allows flexibility in implementing the controls needed to achieve those goals. In this audio conference, our speaker reviews the guidelines, identifies the types of SOPs and controls that are needed, and identifies for the virtual company, what types of SOPs are needed to deal with vendor relationships.
Tuesday, May 11, 2010
Reducing the Impact of Risk Management on Development Budgets and Timelines
is being presented by Dr. Joy Frestedt, President & CEO, with Frestedt Incorporated and airs on Thursday, June 10th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Managing risk is an evolving specialty, and is becoming more critical thanks to increasingly strict global regulatory requirements for risk evaluation and management. No longer is simply recording and reporting adverse events sufficient to demonstrate due diligience for ensuring consumer safety. The need to proactively track, trend and attempt to predict risk-related issues is now critical and is a required part of every drug, device and biological design program.
This audio conference presentation looks at current trends in risk management, and how it can impact development budgets and timelines for drug and device manufacturers. Our speaker also shares valuable insight on practical activities and the training required to effectively reduce costs and speed timelines when conducting risk evaluation and mitigation strategies.
Managing risk is an evolving specialty, and is becoming more critical thanks to increasingly strict global regulatory requirements for risk evaluation and management. No longer is simply recording and reporting adverse events sufficient to demonstrate due diligience for ensuring consumer safety. The need to proactively track, trend and attempt to predict risk-related issues is now critical and is a required part of every drug, device and biological design program.
This audio conference presentation looks at current trends in risk management, and how it can impact development budgets and timelines for drug and device manufacturers. Our speaker also shares valuable insight on practical activities and the training required to effectively reduce costs and speed timelines when conducting risk evaluation and mitigation strategies.
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