1<!DOCTYPE html>
2
3Anonymous
4/bestp
5/bestp/domrep.nsf
634FB66B0C98483708525744400717978
8
9
10
11
12
13
140
15
16
17/bestp/domrep.nsf/products/safety-and-risk-management-in-the-pharmaceutical-sector?opendocument
18
19opendocument
2018.208.211.150
21
22
23www.best-in-class.com
24/bestp/domrep.nsf
25DB




Products & Services Business Operations Research and Development Communications

Safety and Risk Management in the Pharmaceutical Sector

DB Image

ID: 4998


Features:

Metrics, Graphics


Pages/Slides: 9


Published: Pre-2013


Delivery Format: Online PDF Document


 

License Options:
close

Single User: Authorizes use by the person who places the order or for whom the order was placed.

Sitewide: Authorizes use of the report for a geographic site. All people at site can view the report for a year and copies can be printed.

Corporate: Authorizes use for the entire company for a year and copies can be printed. No limitations for usage inside the company.




Buy Now

 

919-403-0251

  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • SPECIAL OFFER

Non-members: Click here to sign-up for a complimentary tour of
"Safety and Risk Management in the Pharmaceutical Sector"


STUDY OVERVIEW
The pharmaceutical industry is caught in a safety storm that has gained strength since Merck pulled Vioxx from the market in 2004. This document by Best Practices, LLC looks at how the pharma industry has responded to heightened regulatory concerns surrounding safety and risk management. Additionally, the study examines the Risk Evaluation and Mitigation Strategy section of the Food and Drug Administration Amendments Act of 2007 and its implications for the industry. Regulatory leaders can use this study to see how other organizations approach the issues of safety and risk management.

KEY TOPICS

  • Refocusing on Safety
  • Risk Evaluation and Mitigation Strategies
  • Changing Safety Landscape

METRICS
  • Program Changes in Response to FDA's Increased Emphasis on Safety
BEST PRACTICES
  • Consider Hiring more Safety Experts to Address FDA Safety Priorities
  • Pay more Attention to FDA Safety-Related Requests to Speed Review Process
  • If Safety Issue comes up, go to FDA with a Plan to Address it

METHODOLOGY
Best Practices, LLC research analysts used a two-pronged approach to produce this study: surveys and interviews. The survey component included responses from 16 leading pharma and biotech companies. Qualitative best practices are taken from interviewed leaders at select companies.

Industries Profiled:
Pharmaceutical; Biotech; Manufacturing; Consumer Products; Diagnostic; Medical Device; Health Care; Chemical


Companies Profiled:
Alcon; Eli Lilly; United Therapeutics; Amgen; Bristol-Myers Squibb; Boehringer Ingelheim; Bayer; AstraZeneca Pharmaceuticals; Merck; Genentech; Valeant; Roche; Novartis; Solvay Pharmaceuticals; Medtronic


If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.