Meet the EXTEDO experts at DIA 2024 Regulatory Submissions, Information, and Document Management Forum (RSIDM) in North Bethesda.
At DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) Forum, industry and regulatory stakeholders working across the scope of regulatory information will present current and evolving data standards and requirements and effective regulatory information management approaches to align related people, processes, and technology. This Forum provides networking, knowledge sharing, and education opportunities for both business and technology-focused attendees. Meet our team at the EXTEDO booth #104!
Our expert Frank Dickert will be part of the IDMP pre-conference workshop to discuss the business advantages of IDMP sharing EXTEDO's experience and knowledge about IDMP.
If you are not able to join the pre-conference workshop, make sure you do not miss his presentation:
Enhancing Global Regulatory Collaboration: Implementing eCTD for WHO Submissions
In recent years, the World Health Organization (WHO) has made significant strides towards modernizing and streamlining regulatory processes for pharmaceutical and biotechnological products. One of the key initiatives in this journey has been adopting the Electronic Common Technical Document (eCTD) format for submitting regulatory dossiers.
This presentation will provide a comprehensive overview of the WHO's eCTD implementation, highlighting its benefits, challenges, and impact on the global regulatory landscape. The eCTD standard is designed to facilitate the electronic exchange of regulatory information, fostering improved collaboration and information sharing among regulatory authorities, pharmaceutical companies, and other stakeholders.
The audience will be taken through the registration process and the information to be submitted. WHO took the chance to bring all three submission types (Finished Vaccine Products, Finished Pharmaceutical Products, and API) together into a new Module 1, allowing to handle the submission types more efficiently and smoother
Additionally, challenges faced during implementation will be addressed, including issues related to data security, infrastructure, and varying degrees of regulatory maturity across different regions.