Best Practices for Writing Safety Narratives

is being presented by Dr. Susan Sisk, Principal, with SFP Consulting, LLC and airs on Wednesday, June 1st, 2011. For more details, or to register please visit our site at www.fxconferences.com

As the scrutiny of safety data in marketing applications increases, so too does the importance and number of individual patient narratives. In addition to the customary description of cases for patients who died, those who had serious adverse events, and those who discontinued the trial as a result of an adverse event, narratives for other significant adverse events are also being requested, either at the pre-NDA meeting, or after the application is received (i.e., while the clock is ticking).

Thus, having templates that can accommodate these various events and an efficient process for preparation and review of patient narratives is more important than ever before. In this audio conference presentation, our speaker shares insight and best practices on developing templates and writing and reviewing patient safety narratives.

Periodic Safety Update Reports: Be Compliant and Cost Effective

is being presented by Dr. Hemendra Misra & Mark Nelson Tyrrell, with PRA International and airs on Tuesday, March 23, 2010. For more details or to register, please visit our site at www.fxconferences.com

Periodic Safety Update Reports (PSURs) are a regulatory requirement in the European Union, Japan, and in an increasing number of ICH and non-ICH countries. The US FDA, in conjunction with the goal to harmonize reporting globally, also accepts a PSUR in place of the Periodic Adverse Drug Event Report (PADER).

Planning and writing of PSURs involve significant effort and costs. In times of peak workload, pressing timelines or competing priorities, maintaining compliance becomes a challenge. Lessons learned from the industry were employed to develop customized strategies to keep up with the associated regulatory, scientific and public health demands.

Medical Device Vigilance: An Input to Risk Management

Risk management is the process by which medical device manufacturers ensure that their devices are used with the minimum of risk. The risk management process involves assessing all theoretical, potential and actual risks for a product (the inputs), assessing the impact of those risks on the user of the device, and putting in place strategies to mitigate those risks (the outputs). Early in the device development process, most of the risks are theoretical. However, as the device moves into clinical use, safety data are generated and real risks are identified or confirmed.

This audio conference presents information about how vigilance (the collection and appraisal of human safety information), supplemented by non-clinical and bench data, feeds into the risk management process, and how the outputs are managed. This sounds like a fairly simple process, but interpreting vigilance data is not always easy. There may be internal corporate resistance to ideal modes of risk mitigation, and it is difficult to deal with risks that arise from misuse of the device. All of these issues are dealt with and illustrated by case studies presented in the audio conference.

Medical Device Vigilance: An Input to Risk Management is being presented by Helen Colquhoun, MD, CEO, with Pleiad Devices and airs on Thursday, July 9, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Considering Human Factors in Designing Medical Device Trials

Increasingly, the FDA is requiring that clinical evaluations take into account human factors and their effects on device design. It is becoming more important to address how these affect the safety, performance and reliability of medical device use to ensure appropriate device design. Evaluating the human interface in the user environment produces critical data for pre-market applications to the FDA. However, medical device trials intending to collect these unique data must be carefully designed to bring the most valuable data to light.

In this audio conference the speaker looks at various human factors which must be taken into consideration when designing a medical device clinical trial, and uses a series of real-life examples to illustrate how best to incorporate them into the design process. In addition, all attendees will receive a copy of Pleiad's Human Factors Considerations checklist.

Considering Human Factors in Designing Medical Device Trials is being presented by Annette Valles-Sukkar, Senior Manager, Clinical Operations, with Pleiad Devices and airs on Thursday, May 7, 2009. For more details or to register for this event, please visit our site www.fxconferences.com