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Drug Safety in China - Market Analysis Report

Our Drug Safety Activities

Universal Medica has acquired a strong expertise in drug safety management in China, Europe and the US. Our team of experts has successfully provided in- and out- sourced solutions for pharmacovigilance, medical information and risk management services to a large panel of customers.

Our Medical Information services include:
  • 24-hour contact center for healthcare professionals and patients (call center, e-mail request, fax, 24/7 hotline)
  • Sales force and medical liaison requests management
  • Standard response (level 1) and scientific review (level 2 inquiries)
  • Signal detection review
Our Pharmacovigilance services include:
  • Collection, review, and follow-up of serious adverse events
  • Generation of regulatory reports, including Annual Safety Reports, and periodic safety update reports
  • Submission of reports to regulatory authorities
  • Adverse events’ literature search/review

Our dedicated team of drug safety experts also provides custom-made solutions to help clients to implement and evaluate efficient risk management strategies. We focus on high quality solutions in accordance with current regulatory and legal standards. We trust in successful and long-term collaboration through our flexibility and reactivity.

Drug Safety in China – Market Analysis Report

Table of contents
Chapter 1: BACKGROUND
  • Common definitions
  • The aim of pharmacovigilance
  • Causality assessment methods
Chapter 2: THE HEALTHCARE SYSTEM IN CHINA
  • Overview
  • Leading healthcare authorities in China
Chapter 3: DRUG SAFETY MANAGEMENT IN CHINA
  • Recent drug safety concerns in China
  • The actors of drug safety
  • Laws and regulations governing drug safety in China
  • The new guidance governing ADR monitoring and reporting, July 1st 2011
  • Adverse drug reactions reporting and monitoring system
  • Publications and media
Chapter 4: DRUG SAFETY IN EUROPE
  • Drug safety concerns in Europe
  • European regulatory authorities
  • Regulatory context of safety in Europe
  • The new community legislation related to pharmacovigilance, December 15th, 2010
  • Pharmacovigilance system in Europe
Chapter 5: COMPARISON OF SYSTEMS BETWEEN EUROPE & CHINA

 

Chapter 6: HOW TO IMPROVE DRUG SAFETY IN CHINA
  • Medical information
  • Pharmacovigilance
  • Crisis Management
  • Risk management plans
IMPLICATIONS & CONCLUSION

 

APPENDICES