Friday special - save 75% on "GCP for Medical Device Trials: Upcoming Revisions to ISO 14155"

An important standard for conducting medical device research is changing. How will it affect you?

Conducting global clinical trials in accordance with recognized standards provides improved assurance that clinical trial data will be accepted to support global marketing authorization applications. ISO 14155 (clinical investigation of medical devices for human subjects - Parts 1 and 2) is currently under revision.

This audio conference focuses on the status of revisions to ISO 14155, anticipated changes to the standard, and acceptance of the standard by regulatory authorities. This presentation reviews the required clinical investigation elements presented under ISO 14155 and provide tools for integrating the standard into your clinical research quality system.

Participants also receive a medical device clinical research map comparing requirements of ISO 14155 (2003) Parts 1 and 2, the draft revised ISO 14155, and FDA 21CFR 820. The speaker also provides attendees with an essential clinical investigation document checklist.

But hurry! If you purchase GCP for Medical Device Trials: Upcoming Revisions to ISO 14155 by November 12, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.

Protecting Data Under Current EU Pharma Legislation

European pharma legislation has seen several major changes come into effect over the past several years. Amongst others, the data protection rules have changed substantially. The data protection period for new approvals is now 8+2+1 years. The orphan protection, a full market exclusivity period, is 10+2 years. And the very recently introduced legislation on paediatric drugs (PUMA and PIP) plays an important role as well. The concept of the "Global Marketing Authorisation" needs consideration for the planning of the effective data protection period.

This presentation helps attendees understand current EU data protection rules and how best to operate within the regulatory framework.

Protecting Data Under Current EU Pharma Legislation was presented by Dr. Ulrich Granzer, with Granzer Regulatory Consulting & Services and aired on 2006-12-14. For more details or to download this event, please visit our site at www.fxconferences.com

Comparative Effectiveness Research: Threat or Opportunity?

Comparative effectiveness research (CER), a prominent component of legislative and regulatory efforts to rationalize the use of health care resources, improve outcomes and constrain the explosive growth of health care spending, is widely perceived as a financial threat by medical technology and pharmaceutical companies. During the current healthcare reform debate, industry has supported stringent limits on payers’ use of CER results in an effort to minimize its impact. But CER also has the potential to define new market opportunities for existing technologies and to open new pathways for the introduction of innovative diagnostics and therapeutics. Opposition to CER initiatives may foreclose significant growth potential for industry.

This presentation explores how CER is likely to be implemented, analyzes the nature of the threat posed by CER to the commercial status quo, and evaluates the opportunities that a robust implementation of a CER program would create.

Comparative Effectiveness Research: Threat or Opportunity? is being presented by Dr. Edward E. Berger, Principal and Founder, Larchmont Strategic Advisors and airs on Thursday, December 3, 2009. For more details or to register, please visit our site at www.fxconferences.com

Clinical Trial Success in Latin America

Latin America has proved to be a solidly performing region for clinical trials, catching the interest of global pharmaceutical and biotech companies. GCP (Good Clinical Practice) has been adopted as local regulatory requirement in most Latin American countries over the last decade. Since then, industry-funded clinical research has grown rapidly, and Latin America is routinely considered for global drug development programs. The reasons for this growth are simple: a large patient population, solid investigators with experience in clinical research, well-equipped qualified study institutions, strengthened clinical research infrastructure (laboratories, drug depot services and logistics), and internationally recognized standard treatments.

This audio conference reviews the major factors that have made Latin America a successful region for global clinical research studies. Drawing on recent experiences, the speaker outlines the benefits and challenges to managing Latin American clinical trials, while sharing practical advice on critical points to take into account when conducting trials in Latin America.

Clinical Trial Success in Latin America is being presented by Dr. Frederico Lerner, Senior Director of Operations, with PRA International and airs on Friday, November 13, 2009. For more details or to register, please visit our site at www.fxconferences.com

EDC Front to Back: Integrating Clinical Trial Data for Operational Benefit

Successfully implementing EDC depends on having processes in place that take advantage of the technology. Although it is generally possible to use EDC with processes that were designed for paper case report forms, there are many ways EDC can be integrated into the clinical trial process to make it more efficient, and depending on the goals for EDC, there are many metrics that can be captured to help establish benefits. Among these are cycle time for resolving queries, use of standards, quality of data, cost per form or datapoint, time between last patient visit and database lock.

This conference explores how processes related to EDC can be integrated into clinical trial processes for creating and deploying case report forms, as well as monitoring and managing trials. Our speaker shares insights on how to use lean concepts to look at the processes you have, identify opportunities for improvement and show measurable progress.

EDC Front to Back: Integrating Clinical Trial Data for Operational Benefit is being presented by Ross Rothmeier, Senior Director, EDC Portfolio, Clinical Development Services, with Covance and airs on Tuesday, November 17, 2009. For more details or to register, please visit our site at www.fxconferences.com