Enhancing the Creation of Compliant Regulatory Submission Dossiers with a Thorough Understanding of Module 1 Guidelines and Implementation Strategies, Impact of AI and Digital Innovations through to Reduction of Technical Deficiencies
With the goal to swiftly release new products to the market, pharmaceutical and biotechnology regulatory publishing and submissions executives are challenged to present comprehensive and technically flawless product dossiers to regulatory authorities globally. The continued push for harmonized global regulations and impact of new technological capabilities has confronted regulatory operations executives with a multitude of hurdles to overcome while ensuring timely and compliant dossier submissions. Building on knowledge share and successes of past years, the 2018 program will showcase industry experts in regulatory operations and publishing, who will share experiences and knowledge that will be of great benefit to all attending delegates. Industry leaders will address a multitude of topics ranging from Module 1 guideline updates and implementation strategies, expanding on differing global dossier and data requirements, and exploration of artificial intelligence’s potential to impact submission development processes.
Lydia Welmer | Marketing Coordinator | Q1 Productions
312.955.0897 | firstname.lastname@example.org