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How regulatory professionals can apply the RAPS Code of Ethics to
current and future endemic disease outbreaks characterized by a rapidly
developing healthcare situation and quickly evolving knowledge base
regarding prevention, treatment and potential cures.
Three EU agencies have announced they will work together in the hopes of better understanding one of today's most pressing global healthcare issues: Antimicrobial resistance (AMR).
South Korean medical device regulators will implement significant changes affecting compliance requirements for in vitro diagnostic (IVD) registration as well as for Korean Good Manufacturing Practice (KGMP) audits over the course of 2015.
In a move that promises to bring greater clarity to India’s regulatory process for pharmaceutical products, India’s regulator has announced plans to formalize a process for pre-submission meetings (PSMs).