Unlocking The Value Of Regulatory Dossiers Through Next Generation eCTD Viewing Technology
- What: Webinar – “Unlocking The Value Of Regulatory Dossiers Through Next Generation eCTD Viewing Technology
- When: Wednesday, October 26th, 2022, at 10:00 AM Eastern Time
- Where: Online Event
- How: Register Here
- Why: This webinar will illustrate how Dossplorer™ regulatory dossier viewer supports regulatory processes, such as the regulatory impact assessment.
Webinar Series Background
Applicants dedicate a vast amount of time and effort to get their regulatory submissions in compliance with exchange standards (such as eCTD) in order to facilitate the review process by the Health Authorities with the ultimate goal of obtaining approvals. These applications contain a wealth of knowledge about the Medical Product and its Life Cycle and are therefore to be treated as a valuable asset for the company. With the help of Dossplorer™ these submissions can not only be used to transfer information to the Regulators, but also support numerous other business cases (e.g., regulatory impact assessment).
Traditional eCTD viewing tools are often limited to viewing single applications (a single product in a single country) at a time. Although this is how eCTD is currently handled by the regulators, this is not how companies manage their products internally. For example, a regulatory impact assessment is to be performed across various products and registrations. Dossplorer™ offers unique viewing capabilities beyond the traditional sequence/cumulative/current view. This enables users to create holistic views across multiple applications which supports fast and informed decision making.
Unfortunately, for the most part regulatory information is still trapped in ‘digitalised paper’ in the form of PDFs. To unlock this information Dossplorer™ offers full text indexing and advanced analytical capabilities.
This featured presentation will be led by Qdossier’s Director of Regulatory Information Management, Michiel Stam. Michiel will also be available after the presentation for a live Q/A session.
Qdossier, a Celegence Company, will be hosting the webinar on Wednesday, October 26th at 10:00 AM Eastern Time – Register online now!
The checklist highlights all of the documentation that you will need in place for certification of your IVD device and will serve as a guide to help you achieve ongoing compliance. In conjunction with this checklist, we are also able to provide you with bespoke strategies to bring your business up to speed. We are currently working with businesses from the United States, India, and throughout Europe to ensure that they are ready for the deadline in May of 2022.
Webinar Featured Presenter – Michiel Stam
- Michiel Stam started his career 15 years ago in eCTD publishing and submissions, before shifting focus to Regulatory Information Management (RIM). He is also the former product owner of Dossplorer™.
- Currently Michiel holds the position of Director Regulatory Information Management and provides strategic direction and subject matter expertise for implementation of Regulatory Information Management (RIM) solutions.
- Michiel has worked on various eSubmission projects including the preparation and submission of initial MAA’s and post-authorization maintenance applications for agencies in the EU (CP/MRP/DCP and Nationals), US (NDA/BLA/IND) and other regions such as GCC and Switzerland
Webinar Tenets
The presentation will include:
- An introduction and background for development of Dossplorer™, including a high-level overview of the system architecture
- How Dossplorer™ offer unique views on eCTD, NeeS and other dossier formats beyond traditional eCTD viewing capabilities
- An overview of Dossplorer’ s advanced analytical capabilities
The checklist highlights all of the documentation that you will need in place for certification of your IVD device and will serve as a guide to help you achieve ongoing compliance. In conjunction with this checklist, we are also able to provide you with bespoke strategies to bring your business up to speed. We are currently working with businesses from the United States, India, and throughout Europe to ensure that they are ready for the deadline in May of 2022.
Webinar Learning Objectives
- Hear Michiel’s key insights into the regulatory processes and submissions
- Examine examples and relevant case studies
- Have your most pressing questions answered during the Q/A session
Who Should Attend?
This webinar is aimed towards companies in the life sciences industry, including middle and top level global regulatory professionals involved in:
- Regulatory Affairs
- Medical/Regulatory Labeling/Scientific Writing
- Regulatory Operations
- Electronic Regulatory Submissions
- Document and Project Management
Who Should Attend?
“Unlocking The Value Of Regulatory Dossiers Through Next Generation eCTD Viewing Technology” Webinar will be held on October 26th, 2022, from 10:00 AM Eastern Time. Make sure you secure your place at the webinar by registering now.
Full Spectrum Services for Medical Device and IVD Manufacturers
Qdossier, a Celegence Company, provides regulatory outsourcing services and can take either full responsibility of regulatory deliverables or engage remotely and/or on-site in operational activities within your company. Our team has vast experience with the compilation, submission, and maintenance of regulatory dossiers, registration tracking, IDMP/XEVMPD and document- and data migration. We are happy to share our insights with you during this webinar and hope that you can join us then.
Reach out to us at info@qdossier.com to learn more, contact us online or read more about Qdossier’s services.
