2nd Annual Pharmaceutical Regulatory Writing and Submissions Conference
06 May 2013 - 07 May 2013 - Alexandria, VA, USA
In today’s industry there is an ever increasing pressure for pharmaceutical manufacturers to develop and quickly release new therapies and treatments to the public. However, the highly regulated nature of the pharmaceutical and biotechnology industry has provided a major hurdle for many organizations; and the necessity to generate quality and compliant product submission dossiers is vital to securing the required approvals to release products onto the market. Medical writers and submissions specialists are tasked with the crucial responsibility of translating the overwhelming amount of clinical data and required supporting evidence into readable, easily understandable, and properly formatted documents that are submitted to health authorities for review. Also, as organizations strive to expand product lines to multiple international markets where individual regulatory authorities require specific information, writers and submissions specialists are continually faced with the challenged of not only compiling timely and quality submissions but ensuring compliancy with all international regulatory requirements.