Enhancing the Creation of Compliant Regulatory Submissions Dossiers with a Thorough Understanding of Module 1 Guidelines, Preparation Strategies for eCTD 4.0 Implementation, and Optimization Processes for Managing Submissions Timelines
As a result of continuous change within the industry, the role of regulatory operations has developed from an organizational based function to a more strategic role and serves as a central point of coordination during the submission process. With the continued rise in technological advancements and changes within global submission requirements, regulatory operations executives have been challenged to seamlessly integrate new technical capabilities into submission processes while ensuring compliant and timely submissions. Guiding best practices for inputting data under the correct electronic format, maintaining comprehensive knowledge regarding regulatory requirements, and upholding submissions documents throughout the entirety of the product lifecycle encompass this dynamic role. Regulatory operations teams are challenged to ensure all duties are compliantly performed on deadline in a highly time sensitive environment.
Building on conference knowledge share and successes of past years, the 2019 program will showcase industry experts in medical communications and publications, who as presenters will share experiences and knowledge that will be of great benefit to all attending delegates. Through detailed case study presentations and open forum panel discussions, this year’s presenters will address a wide range of issues from eCTD 4.0 preparation, global regulatory dossier considerations, and highlighting changes regarding Module 1. The 8th Annual Regulatory Operations and Submissions Conference will foster a sense of collaboration and promises to be a valuable program to those who are looking to streamline and enhance regulatory submission processes.
This program is eligible for up to 6.5 RAC credits. A certificate of attendance and final digital copy of the agenda will be provided to all attendees upon request. For further details regarding the submission process for RAC credits, please visit: https://q1productions.com/raps-credit/