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Requirements for Launching New Products - USA & Internationally

Tuesday, April 30, 2013
1818 Market Street, Suite 2200, Philadelphia, PA
Philadelphia, United States

Event Type: Seminar

This 4 hour program is designed for biotechnology, pharmaceutical and medical device business executives, in¬vestment bankers, advisors and their clients, and others with interest how to meet new requirements to demonstrate comparative effectiveness and real world drug and medical device impact for health care payers.

The global economic crisis and ageing populations in the US, Europe and other countries are putting pressure on health care budgets and health care payers are increasing focus on demonstration of comparative effectiveness of new products in terms of efficacy, safety, health care impact and cost relative to current standard therapies. 

In addition there are new requirements for data to demonstrate that a product is working as expected once it is on the market. Many health care payers are adopting ‘pay for performance’ and conditional reimbursement programs that need to be supported by real world studies of how a new product is helping the population of patients given the drug.

This workshop will provide you with the knowledge to understand the new requirements by health care payers and the tools to design and execute comparative effectiveness evaluations and real world studies of product impact.

Comparative effectiveness evaluations incorporate structured literature reviews and meta-analysis of study results to provide estimates of incremental product effect in the absence of comparative clinical trials. These evaluations often form the core data to support the value of a new drug to health care payers.

Real world studies are different from randomized controlled trials and are based on observational study designs. In addition, because these studies are intended to represent ‘real-world’, data collection could be directly from patients and include physicians who have no prior experience with clinical research. 

This workshop will teach you about:

  • Requirements by health care payers for Comparative Effectiveness Evaluations and Real World Data of Health Care Product Impact
  • Comparative Effectiveness Evaluations – Definition, methods, limitations and practical strategies for completion to ensure accuracy.
  • Real World Studies: Design, approval, conduct and analysis
  • Case studies of Comparative Effectiveness Evaluations and Real World Studies that helped to gain product approval and reimbursement.
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