CIOMS has published a new report entitled: “Real-world data (RWD) and real-world evidence (RWE) in regulatory decision making”.
ICH has published the M14 draft Guideline entitled “General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines”.
The FDA has published a new draft guidance for comments, which provides a systematic, structured approach to the design, implementation, and evaluation of a REMS.
The Medicines Control Authority of Zimbabwe (MCAZ) has published a revised version of its “Pharmacovigilance Guideline for Pharmaceutical Industry”.
You're almost done. Please provide your email address below and we will send you the link to access a sample report for free !
You're almost done. Please provide your email address below and we will send you the link to access a sample report for free !
You're almost done. Please provide your email address below and we will send you the link to access a sample report for free !
You're almost done. Please provide your email address below and we will send you the link to access a sample report for free !