Complying with Regulations, Reviewing RMPs for Asia, and Improving Audits and ADR Reporting
The Asia Pacific region has seen the introduction of stringent local and global regulations which have forced the concept of pharmacovigilance to expand beyond just identifying adverse events to incorporating risk management plans. Today pharmacovigilance is on the minds of every pharma and bio executive, and starts earlier in the drug development process. And rightly so, considering the startling fact that 200,000 patients die each year from Adverse Drug Reactions.
Pharma/Biotech companies are faced with the challenge of finding solutions that can improve the quality and analysis of safety data, while managing the increase in the quantity of data and the need to satisfy regulatory requirements.
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