In order for a new drug or therapy to gain marketing authorization, writers must coordinate with various stakeholders to gather, organize and compile information on new products or processes; interpret data from clinical trials; and find efficient ways to present trial findings. These documents are then submitted to the FDA, EMA and other regulatory authorities for their approval, with very little time to respond to inquiries or provide additional information.
Given the constant evolution of US and international regulations, it is vital that medical writers stay up to date with the ever-changing regulatory landscape and find innovative approaches to managing the writing process to meet deadlines.
The 6th Clinical Regulatory Medical Writing Forum will address recent regulatory changes and feature industry leaders as they discuss process improvement strategies. Return to work armed with the necessary tools and techniques to contend with aggressive deadlines.