New Report on "Benchmarking Drug Safety and Pharmacovigilance" added in Vision Shopsters
07/13/2010

This study shows how to align your team, assign responsibility for investigational and post- market products, determine the most appropriate activities to outsource, and understand how to choose among drug safety vendors.

Online PR News – 13-July-2010 – – It’s clear to pharmaceutical and biotechnology executives that drug safety teams are vital to protecting patients and keeping drugs on the market. Some high-profile examples of poor drug safety efforts over the past decade — and even some more recently in 2010 — have prompted the pharma industry to invest more in drug safety. Beyond changes to investments and added resources, companies are beginning to regard drug safety in more strategic terms.

Benchmarking Drug Safety and Pharmacovigilance provides best practices for pharmaceutical and biotechnology teams to structure their drug safety teams, develop pharmacovigilance strategies, allocate budgets and headcounts appropriately, and learn when to initiate critical pharmacovigilance activities. Explore real-company strategies and metrics for companies’ drug safety and pharmacovigilance teams:

To know more about this report & to buy a copy please visit :
http://www.visionshopsters.com/product/3308/Benchmarking-Drug-Safety-and-Pharmacovigilance.html

Learn what it means to develop a strategic drug safety team: Many drug company executives view drug safety as a required function or as nothing more than a cost center. This study uncovers best practices that top-notch drug safety and pharmacovigilance teams have in place to deliver strategic impact.

Optimize your drug safety team: Several factors affect the size and structure of drug safety and pharmacovigilance teams. This study shows how to align your team, assign responsibility for investigational and post- market products, determine the most appropriate activities to outsource, and understand how to choose among drug safety vendors.

Prove the drug safety team’s value: Performance measurement for pharmacovigilance activities are few and far between. So how does a drug safety team demonstrate its impact to the bottom line? This study showcases best practices to measure and prove the value of a strategic drug safety team.
METRICS INTRODUCTION

Benchmarking Drug Safety and Pharmacovigilance' s three chapters include metrics detailing drug safety/pharmacovigilance budgets and outsourcing, structure and staffing, and timing of activities. In many cases throughout the report, data are broken down by company type - large, mid-size, small and biotechnology.
Chapter 1: Budgets and Outsourcing

Budget Data

* Total and US-only drug safety budgets
* Drug safety budget allocation
* Budget centralization (dedicated budgets versus funded by various departments)
* Departments that contribute to non-centralized drug safety budgets
* Budget coverage (number of investigational and marketed drugs covered)
* Percentage of drug safety budgets allocated to various global markets, including the US, UK, France, Spain, and Japan

Outsourcing

* Percentage of companies that outsource some portion of the drug safety budget
* Percentage of drug safety budget outsourced, by company
* Types of products and pharmacovigilance activities covered by vendors
* Types of vendors employed (e.g., those who provide turn-key solutions versus ad hoc services)
* Countries in which companies spend outsourcing dollars

Chapter 2: Structure and Staffing

Structure

* Drug safety structures and team makeup
* Percentage of companies with in-house teams to manage drug safety/pharmacovigilance
* Centralized versus decentralized structures
* In-house departments' drug safety responsibilities
* Other departments with some oversight of drug safety groups
* Percentage of investigational compounds for which in-house drug safety groups conduct activities
* Percentage of marketed drugs for which in-house drug safety groups conduct activities

Staffing

* FTEs dedicated to drug safety
* Percentage of staffing positions held by contract employees
* Position breakdowns within drug safety groups
* Activity breakdowns across drug safety staff

Chapter 3: Pharmacovigilance Activities, Timing and Communications

Activities

* Phase in which drug safety activities begin
* Percentage of drug safety groups performing different specific activities
* Phase in which companies begin safety and technology services/IT solutions (database hosting, migration, maintenance and support)
* Phase in which companies begin the following:
o Case management
o Aggregate report development
o Regulatory submissions
o Medical services
o Literature services
o Signal detection and management
o Due diligence projects
o Risk mitigation strategy
o PSUR (Periodic Safety Update Report) and ASR (Annual Safety Report) development
o United States and European regulatory consulting
o Consulting and training

Internal Processes

* Phase in which clinical development gets involved in drug safety on a brand
* Phase in which medical affairs gets involved in drug safety on a brand
* Phase in which legal gets involved in drug safety on a brand
* Phase in which risk management gets involved in drug safety on a brand
* Phase in which regulatory gets involved in drug safety on a brand

To know more about this report & to buy a copy please visit :
http://www.visionshopsters.com/product/3308/Benchmarking-Drug-Safety-and-Pharmacovigilance.html

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