Alexander Varond is presenting at the Regulatory Operations and Submissions Conference

Successful Orphan Drug Applications


April 28, 2016

5th Annual Regulatory Operations and Submissions Conference

Ensuring Timely Product Approvals through the Creation of Quality and Compliant Regulatory Submission Dossiers with a Comprehensive Understanding of Submission Management Tools, Cloud Based EDMS Opportunities & Dossier Review Strategies

April 27-28, 2016 | Philadelphia, PA


With new formatting guidelines, data requirements and eCTD formats being release within the industry recently, that challenges facing regulatory submission experts continue to evolve as organizations seek to gain speedy product approvals. Regulatory operations and submission executives are tasked with ensuring that the plethora of dossier documents created by regulatory authors are compliantly transferred into the required submission format and retain navigability so that reviewers have easy access to required product data. This process complicated not only by evolving differing global standards but also with the release of new technological systems and cloud based applications.

Building on conference knowledge share and successes of past years, the 2016 program will showcase industry experts in submissions and regulatory operations, who as presenters will share experiences and knowledge that will be of great benefit to all attending delegates. Industry leaders will cover a plethora of areas from updates regarding Module 1, global submissions standards, submission review best practices through to increased transparency measures in accordance with EU policy 70. Through case study driven presentations, as well as interactive panel discussions complemented by multiple networking opportunities, the program will foster a sense of collaboration and promises to be a valuable program to those who are looking to streamline and enhance regulatory submission operations.