Stay in the Game: Leading Pharma and Biotech Teams in Tough Times

What do you want others to say of your leadership during these challenging times? When the going gets tough, thanks to conditions such as dropping revenues and profits, mergers and acquisitions, re-organizations or shrinking pipelines, there is an opportunity for leaders to step up and stand out. It is also a time to step back for a little self-reflection on just what are the leadership requirements for this “new normal” of organizational life.

Based on over 20 years of experience working with such companies as Pfizer, Sanofi-Aventis, Biogen Idec and Boehringer Ingelheim, in both research and commercial divisions around the world, Lynda McDermott provides attendees with “best practice” leadership learnings and tools to help you and your people “stay in the game."

Stay in the Game: Leading Pharma and Biotech Teams in Tough Times is being presented by Lynda McDermott, President, of EquiPro International and airs on Thursday, December 17, 2009. For more details or to register, please visit our site at www.fxconferences.com

Cost & Effectiveness: Healthcare Reform and its Implications for Pharma & Devices

With health care reform on the horizon, the business case for quality and efficiency in health care has never been clearer. The new system will encourage payers to reimburse only for consistent and efficient care. Increasing transparency will make it easier for patients, who will in turn demand care that meets their needs. Preparing for the future of health care is therefore critical to the survival of many organizations. This changing health care landscape will have implications for medical providers and suppliers alike.

This session provides an overview of health care reform by understanding Massachusetts reform as a likely model. Dr. John Freedman outlines how such changes are likely to impact clinicians, as well as medical suppliers. This includes outlining key macro trends related to performance measurement, improvement, efficiency and cost containment.

Cost & Effectiveness: Healthcare Reform and its Implications for Pharma & Devices is being presented by Dr. John Freedman, Principal, of Freedman HealthCare, LLC and airs on Thursday, December 3, 2009. For more details or to register, please visit our site at www.fxconferences.com

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