Best Practices for Preparing Clinical Evaluation Reports

is being presented by Phil Triolo, President, of Phil Triolo and Associates LC and airs on Tuesday, March 22nd, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com

Clinical Evaluation Reports (CERs) document the assessment and analysis of clinical data (literature, results of clinical investigations, complaints) and preclinical data to establish conformity of a medical device with the pertinent requirements of the Medical Devices Directive.

Recent publication of ISO 14155:2011 introduces new requirements that supplement the requirements and recommendations for CERs that appear in MEDDEV 2.7.1 Rev 3 and GHTF document SG5/N2R8:2007.

This audio conference presentation outlines these new requirements and provides helpful hints and examples of how to meet, efficiently and effectively, new and existing CER requirements.

Comparative Effectiveness Research: Threat or Opportunity?

is being presented by Dr. Edward E. Berger, Principal and Founder, of Larchmont Strategic Advisors and airs on Wednesday, September 22nd, 2010. For more details or to register, please visit our site at www.fxconferences.com

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?

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