Research and Markets: Drug Safety in China: A Strategic Stake for Healthcare Companies

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DUBLIN--(BUSINESS WIRE)-- Research and Markets (http://www.researchandmarkets.com/research/ecc7b6/drug_safety_in_chi) has announced the addition of the "Drug Safety in China: A Strategic Stake for Healthcare Companies" report to their offering.

Be aware of the new MoH rules, from July 2011, tightening the ADR reporting and monitoring environment, for your company to be in line with the Chinese SFDA requirements

Our experts' team has successfully provide in- and out- sourced solutions for Pharmacovigilance, Medical Information and risk management services to a large panel of customers.

Our background

Our Pharmacovigilance services include:

  • Collection and follow-up of adverse events
  • Safety signed detection and analysis
  • Literature search execution for adverse events
  • Regulatory reports, including Annual Safety Reports and Periodic Safety Update Reports generation
  • Submission of reports to regulatory authorities
  • Pharmacovigilance training and quality audit

We focus on high quality solutions in accordance with current regulatory and legal standards.

Key Topics Covered:

Chapter 1: INTRODUCTION ON PHARMACOVIGILANCE

  • Common definitions
  • The aim of pharmacovigilance
  • Imputability methods

Chapter 2: THE HEALTHCARE SYSTEM IN CHINA

  • Key facts
  • Medical institutions
  • Leading healthcare authorities in China
  • Actors of China drug safety

Chapter 3: RECENT DRUG SAFETY ISSUES

Chapter 4: LAWS & REGULATIONS OF DRUG SAFETY IN CHINA

  • Drug administration law of the people's Republic of China
  • The regulation for the administration of Adverse Drug Reaction reporting and monitoring
  • Local drugs and imported drugs
  • Latest regulations

Chapter 5: ADVERSE DRUG REACTION REPORTING & MONITORING SYSTEM

  • National Center for Adverse Drug Reaction monitoring
  • Annual report on Adverse Drug Reaction monitoring
  • Official periodic publications

Chapter 6: DRUG SAFETY IN EUROPE

  • Recent drug withdrawals
  • Regulatory authorities
  • Regulatory context of drug safety in Europe

Chapter 7: SYSTEMS COMPARISON BETWEEN EUROPE & CHINA

Chapter 8: HOW TO IMPROVE DRUG SAFETY IN CHINA

  • Ethic committees
  • Clinical trials sponsors
  • Investigation centers
  • CROs

Chapter 9: INTERVIEWS

For more information visit http://www.researchandmarkets.com/research/ecc7b6/drug_safety_in_chi



CONTACT:

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

KEYWORDS:   Asia Pacific  China

INDUSTRY KEYWORDS:   Health  Pharmaceutical

MEDIA:

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