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Post Marketing Clinical Research - REMS, the Latest Reformation due to Post Marketing Surveillance, to Enhance Patient Compliance

  • Published: Sep-2011
  • Report Code: GBIHC094MR
  • Report Format: pdf

Description

The GBI Research’s report on, “Post Marketing Clinical Research-REMS, the Latest Reformation due to Post Marketing Surveillance to Enhance Patient Compliance”, provides in-depth analysis of components of post marketing clinical research and its applications. This report provides regulatory landscape of post marketing clinical research in different geographies. The report provides detailed description about conduct of post marketing clinical research in special groups including different populations groups, different therapy areas and drug classes. In this report detailed analysis about outsourcing of post marketing clinical research have been provided. This report showcases criteria for selection of outsourcing partner along with advantages and limitations of outsourcing.

GBI Research in its present report provides detailed analysis of Risk Evaluation and Mitigation Strategies, which are employed to increase patient compliance. Role of Pharmacovigilance, Pharmacoepidemiology and Pharmacoeconomics in Post Market lifecycle of drug has been presented. In this report a detailed analysis about the Adverse Event Reporting System is also provided. This report highlights current regulatory landscape in the US, EU, Japan and other emerging markets. The last part of the report discusses about outsourcing of pharmacovigilance activities.

Scope

  • The report provides in-depth analysis on Post Marketing Clinical Research and its application to lifecycle of drugs.

  • This report contains case studies about market withdrawals issued in recent years with detailed analysis.

  • In this report importance of Post Market Clinical Research in terms of revenues generation, promoting public health, designing of health policies are presented.

  • This report presents detailed analysis on components of Post Marketing Clinical Research. Risk Evaluation and Mitigation Strategies, Pharmacovigilance studies and its applications.

  • This report contains detailed review about safety studies conducted in different population groups.

  • Conduct of post marketing research on products belonging to different therapy areas such as oncology therapeutics, cardiovascular therapeutics, CNS therapeutics and gene therapy are discussed in this report.

  • This report has provided special attention to regulatory guidelines about conduct of Post Marketing Clinical Studies in different geographies including, the US, Europe and Japan.

  • This report presents detailed analysis about outsourcing of pharmacovigilance activities to vendors and its implications on drug safety.

Reasons To Buy

  • The report will enhance your decision making capability by understanding reasons for recent drug withdrawals.

  • Understand recent regulatory developments in various geographies and design of strategies to protect one’s product from confronting safety issues.

  • To analyze major reasons of market withdrawals, along with therapy area and class of the withdrawn drug so as to strengthen these areas of weakness.

  • To analyze current trend in designing Pharmacovigilance studies.

  • To analyze effects of outsourcing of post marketing clinical research to CRO’s.

  • To analyze importance of Phase IIIb/IV in lifecycle management and market positioning.

License Details
Electronic PDF copy delivered via email. Report can be used by individual purchaser only.
Single User Licence
$3500
Electronic PDF copy delivered via email. Report can be shared by unlimited users within one corporate location, e.g. a regional office.
Site Licence
$7000
Electronic PDF copy delivered via email. Report can be shared globally by unlimited users within the purchasing corporation e.g. all employees of a single company.
Global Licence
$10500
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