Advocacy

Sharing Our Insights with the Industry

We Advocate for You

As a trusted thought leader and educator, GlobalSubmit operates as a bridge between sponsors and regulatory agencies. Our senior staff members devote considerable time and energy to advancing industry standards. We promote transparency by analyzing troves of information concerning electronic submissions and sharing this information with the industry. GlobalSubmit’s outreach is extensive and includes

  • Publishing educational materials
  • Conducting online webinars
  • Holding free seminars
  • Speaking at industry conferences
  • Producing the industry-leading blog – The eCTD Summit

Engagement on Many Levels Fosters Innovation

International Conference on Harmonisation (ICH)

GlobalSubmit’s close relationship with ICH members ensures we have the most up-to-date information and influence the future direction of electronic submissions. During the past several years, GlobalSubmit’s Chief Technology Officer, Jason Rock, has represented the FDA’s technical interests and advocated for decisions that benefit the health care industry as a whole as a delegate to ICH Multi-Disciplinary (M2) Expert Working Group (EWG).

Educational Webinars and Roadshows

Every year GlobalSubmit presents a series of public educational webinars. Recent topics have included: Intro to eCTD, eCTD Status and Regulations Worldwide, Introduction to Regulated Product Submissions (RPS), eCTD Archiving Options and Best Practices, eCTD File Formats – Regulations and Regional Differences, Best Practices in eCTD Submission Reviewing, Scanned Document eCTD Readiness, eCTD Metadata, and eCTD operators – Ending the Confusion. GlobalSubmit also hosts discussion panels in leading centers for biotechnology and clinical research to provide valuable regulatory submission guidance directly to the industry. During these roadshows, a moderator leads an expert panel through discussions of successes and frustrations associated with submitting to the Agency. Visit our Event Calendar for a directory of upcoming webinars and roadshows. If you are a sponsor who missed a recent webinar and would like to receive the associated presentation, please contact GlobalSubmit Marketing.

Social Media

GlobalSubmit engages members of the eCTD community daily through a variety of social media channels. The most-read blog in the regulatory submissions industry, The eCTD Summit, contains detailed analysis of new regulations, along with breaking news and trends from a number of very knowledgeable sources. We also post updates, news, and helpful links to Twitter and Linkedin in order to provide real-time intelligence to sponsors and stakeholders.

Conferences and Industry Events

GlobalSubmit’s executives and experts are often asked to speak in front of influential industry gatherings such as the DIA, RAPS, and other conferences. If you are organizing an event where regulatory submissions will be discussed and are looking for an insightful presentation, please contact GlobalSubmit Marketing.