Meeting the Requirements: Blending REMS Science & Operational Execution

We invite you to listen to the PRA Risk Management, Epidemiology and Late Phase Operational experts who are currently consulting, designing and conducting REMS activities under the new FDAAA regulations. These experts give insight into current issues concerning REMS, such as risk management activities, observational safety-surveillance studies and performance-linked access programs. They also discuss the potential payoff from the new REMS requirements, as well as which REMS requirements have been proposed for incorporating adaptive designs.

In this audio conference the speakers present various REMS strategies based on a “tiered” approach, as well as some recent case studies. In addition, the presenters cover lessons learned and program components to consider, based on current FDA thinking and requirements for a REMS.

Meeting the Requirements: Blending REMS Science & Operational Execution is being presented by Mark Nelson Tyrrell, Kathleen Kushner & Jerome Wilson, Director, Safety and Risk Management, Scientific Affairs Director & Senior Scientific Affairs Director, with PRA International and airs on Tuesday, June 16, 2009. For more details, please visit our site at www.fxconferences.com

Regulatory Considerations for R&D in Central & Eastern Europe

Central and Eastern Europe continues to be an attractive place for conducting clinical trials, with rapid patient recruitment and high quality of data. At the same time, the clinical trial industry's single greatest challenge continues to be the regulatory process, which has a key impact on the duration of the study start-up period and on timely patient recruitment.

Regulatory requirements in CEE countries went through dynamic changes within the last couple of years, mostly as a result of the accession of several countries to the European Union, as well as increasing demand for the adjustment of local regulations to international standards coming from the pharma industry. However, regulatory changes still seem to be an ongoing process, and the greatest challenge for sponsors and CROs.

This presentation focuses on major regulatory-related problems, with special attention to site contracting problems, and show practical ways of overcoming them in order to speed up the drug development process.

Regulatory Considerations for R&D in Central & Eastern Europe is being presented by Dr. Malgorzata Szerszeniewska, CEO, with Unimed and airs on Tuesday, July 7, 2009. For more details, please visit our site at www.fxconferences.com

Accelerating Your Innovation Pipeline

Innovation as a distinct management discipline is moving from an academic concept into real-world practice, as many companies progress from a project-by-project approach to a more holistic management system. For a company to grow and renew itself, it must move beyond incremental innovation and build a sustainable capability for innovation. But how do you get started?

In this audio conference, Dr. Gina O’Connor shares insights gained from 15 years of research on how to evolve from an ad hoc, hit-and-miss approach to innovation, to a portfolio of options tied to a company’s strategic intent. This presentation discusses ways to create a more strategic, systematic approach to innovation, and how to orchestrate innovation capacity in response to both favorable and constrained business conditions.

Accelerating Your Innovation Pipeline is being presented by Dr. Gina O'Connor, Academic Director, with Radical Innovation Research Project and airs on Wednesday, July 15, 2009. For more details, please visit our site at www.fxconferences.com

Implementing GMP for Combination Products: What Applies When?

Combination product manufacturers are faced with a major challenge to implement a quality system that complies with applicable FDA Good Manufacturing Practices (GMPs) and Quality System Requirements (QSRs). For 10 years, FDA has been progressively developing regulations for this complex area, yet has provided very few formal guidance documents to help manufacturers.

In this audio conference, you learn how to navigate the regulations to develop effective plans for combination products. Linda Alexander gives you specific examples of current FDA expectations and accepted practices, and teaches you how to customize and apply them to comply. Explore the history of combination approvals in the US, case studies, and important trends and issues for the future.

Implementing GMP for Combination Products: What Applies When? was presented by Linda Alexander, CEO and Founder, with Alquest and aired on 2008-09-18. For more details or to download this conference, please visit our site at www.fxconferences.com

Bulletproofing Personnel Policies Against Litigation

Are you concerned that your HR policies and processes might be leaving you vulnerable to lawsuits? No one sets out to create policy risks and personnel litigation. Yet every year a new crop of employee lawsuits are spawned by claims of inattention, inconsistency or unfairness in applying organization policies.

Learn how to avoid the costly loopholes in personnel policy and you could potentially save your company. This informative seminar helps you learn the basis of good policy and the importance of enforcing it consistently. There are basic rules you must know about workplace grievances and disciplinary issues to limit or avoid negative action altogether, especially litigation.

Grandma was right, you know. An ounce of prevention is worth a pound of cure.

Bulletproofing Personnel Policies Against Litigation was presented by Jay R. Rush, Director of Contracts & Legal Compliance, with Policy Technologies International and aired on 2007-10-18. For more details or to download this conference, please visit our site at www.fxconferences.com