Addressing Cost Pressures in Late-Phase Research

is being presented by Dr. Max Horneck, Head of eClinical Services, with Wega Informatik AG and airs on Thursday, January 19th, 2012. For more details, or to register please visit our site at www.fxconferences.com

There is no question that gathering real-life data on approved drug products is of vital importance. Data collected for marketed drugs is needed to generate thorough knowledge of the safety, efficacy and effectiveness. The challenge for clinical operations arises from significant cost pressure in post-authorization studies, while attempting to maintain an adequate level of quality and achieving study targets. Experience has shown that simply mapping procedures from early to late phase does not give the desired results. Budgets tend to be overstressed while targets and quality remain in danger.

In this audio conference, our speaker draws upon almost two decades of clinical experience and provides insight on how to to effectively maintain control of the study conduct and quality of data with reduced efforts by the use of risk mitigation, regional service providers and business intelligence. This presentation enables the attendees to safely plan and conduct late phase studies at significantly reduced costs while maintaining compliance with current regulations at the desired level of quality.

Reducing Your Risk Under the FCPA & Other Anti-Corruption Laws

is being presented by Jesse A. Witten, Partner, with Drinker Biddle & Reath LLP and airs on Tuesday, May 14th, 2011. For more details, or to register please visit our site at www.fxconferences.com

The U.S. Department of Justice (DOJ) and Securities and Exchange Commission (SEC) have made enforcement of the Foreign Corrupt Practices Act (FCPA) a top priority, especially as it relates to pharmaceutical and medical device manufacturers. No pharmaceutical and device manufacturer can expect to evade a government investigation indefinitely. Even smaller companies need to be able to demonstrate that they exercise due diligence, either in the event of an investigation or if they ever seek to partner or merge with a larger company.

This audio conference presentation provides guidance for companies with international operations on how best to develop and implement a set of internal controls to reduce enforcement risk under the FCPA and other international anti-corruption laws.

Food Advertising & Labeling Substantiation: Responding to Heightened Enforcement Risks

is being presented by Bruce A. Silverglade, JD, OFW Law PC and airs on Wednesday, May 18th, 2011. For more details, or to register please visit our site at www.fxconferences.com

Food and beverage companies making health benefit claims in their product advertising and labeling have been coming under increased scrutiny, and facing heightened regulatory and enforcement risks.

This audio conference presentation explores the implications of new FTC and FDA compliance standards, and discusses how to minimize exposure to these increased enforcement activities. Attendees also learn how federal actions can lead to class action lawsuits against food and beverage companies at the state level, and the steps that can be taken in advance to mitigate the risk.

Current FDA Thinking on Risk Evaluation and Mitigation Strategies

In September of 2009, the FDA issued a draft guidance for industry on the format and content of a proposed risk evaluation and mitigation strategy (REMS), which included REMS assessments and proposed REMS modifications. Many industry experts are working to manage the detailed requirements of this new pharmacovigilence standard to include more and tighter control over drug uses.

This session provides insight into medication guides, patient package inserts, communication plans, timelines and other elements to ensure safe use. Attendees receive helpful tips about the format and contents of REMS submissions, as well as some good practices for execution of REMS strategies.

Current FDA Thinking on Risk Evaluation and Mitigation Strategies is being presented by Dr. Joy Frestedt, Frestedt Incorporated and airs on Thursday, February 11, 2010. For more details or to register, please visit our site at www.fxconferences.com

Design and Regulatory Considerations in Anti-Infective Drug Development

The current regulatory environment in anti-infective drug development is changing due to updates in submission requirements as well as the potential for risk mitigation strategies post-launch. Conversely, the need to develop drugs with acceptable risk/benefit profiles for emerging and re-emerging infectious diseases is certainly present considering the rising concerns of disease due to drug-resistant pathogens, biothreat agents and novel influenza strains.

In this conference our speakers review some of the basic principles surrounding anti-infective drug development in the framework of regulatory submissions. They also provide an update on some of the most important changes in recent years related to specific anti-infective indications.

Design and Regulatory Considerations in Anti-Infective Drug Development is being presented by Dr. John Powers, George Washington University School of Medicine & Dr. Carl Kraus, PRA International and airs on Wednesday, December 16, 2009. For more details or to register, please visit our site at www.fxconferences.com

Effective Risk Management: The Cost of Prevention?

Managing the risk in clinical trials is a hot topic today, but how should it be done, how effective is it, and how do we demonstrate value for our investment?

This presentation outlines the current or transitional approach to risk management and where this could mislead. It moves on to consider the variability inherent within clinical trials and the importance of understanding this in risk management. The final section covers risk mitigation and some of the benefits which can accrue from employing an effective risk management strategy in clinical study delivery.

Effective Risk Management: The Cost of Prevention? was previously presented by Rob Davie, PhD, Vice President, Clinical Service Delivery & Clinical Development Services, Europe, with Covance. For more details or to download this conference, please visit our site at www.fxconferences.com

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

Patent Portfolio Strategies in the Post-KSR Environment

Essential information for legal counsel and product development teams!

The Supreme Court’s decision in KSR v. Teleflex profoundly changed the landscape for biopharma companies and medical device manufacturers when it comes to building patent portfolios and managing them. More recently, the Federal Circuit’s Bilski decision in October 2008 added yet another dimension of complexity.

In this audio conference, we examine how this new environment changes the work of managers and professionals in product development teams, as well as patent professionals seeking to protect innovations. The presentation looks at how to identify and strengthen patents that might be vulnerable to obviousness attacks, and discusses ways to write and prosecute them to mitigate that risk.

Patent Portfolio Strategies in the Post-KSR Environment is being presented by Bruce D. Sunstein, Co-founder and Partner, with Bromberg & Sunstein LLP and airs on Thursday, February 12, 2009. For more details on this conference or to register, please visit our site www.fxconferences.com

Risk Mitigation and Prevention in Real-Life Trials

Managing and preventing risk is an integral part of managing any clinical trial. This presentation showcases a series of real-life examples, and explore ways to leverage sophisticated tools and proactive approaches to managing project-related risk. Naturally, a flexible approach customized to each individual case is required, and this presentation shows how to go about it.

Acknowledging the need for continuous mitigation of project related risks, the speaker also explains and demonstrates methods for overcoming challenges that may occur mid-study, successfully absorbing and minimizing the impact to timelines and resources.

Risk Mitigation and Prevention in Real-Life Trials was presented by Jill Johnston, Senior Director, Project Management & Clinical Ops, with Covance and aired on 2007-04-05. For more details, or to purchase a recording, please visit our site www.fxconferences.com