Implementing M1 for eCTD submissions submitted to the WHO Prequalification Unit (PQT)
On 10 November 2023, the World Health Organization Prequalification Unit (WHO-PQT) published the timeline for the introduction of eCTD submissions for applicants https://extranet.who.int/prequal/ectd-portal. With the start of Phase 1, companies may voluntarily submit applications for new products in eCTD format via the ePQS Portal. To stay compliant with the regulatory requirements, organizations should use the time left to prepare accordingly.
WHO-PQT – Improving global health outcomes
By facilitating timely and equitable access to quality-assured health products, WHO-PQT aims to improve health outcomes and resource utilization. Their prequalification process involves a transparent, scientifically rigorous evaluation. The results guide purchasing decisions for health products by the UN and other procurement agencies. By introducing eCTD submissions, WHO is following the example of numerous national health agencies worldwide, e. g. EMA, who have already successfully integrated them into their daily business operations.
WHO-PQT and EXTEDO – Joining forces for an exclusive webinar
WHO and EXTEDO are delighted to invite you to a joint webinar regarding the upcoming WHO eCTD submissions via the ePQS Portal:
- Use this opportunity to learn from WHO-PQT about the ePQS Portal and its additional functionalities
- Get an overview of the new WHO M1 technical specification and validation criteria by Frank Dickert, Senior Business Consultant at EXTEDO
- See how seamlessly a WHO eCTD dossier can be created and validated in EXTEDOpulse in a live demonstration presented by Maren Müller, Product Manager at EXTEDO
Register now and learn how your organization can approach the future of submissions. Secure your spot in this outstanding event and receive the recording!
21 November 2023, 11:00 am CET, 90 Minutes
- EXTEDO Corporate introduction
- WHO-PQT overview and introduction to the portal (WHO)
- Overview of the WHO M1
- EXTEDOpulse live demonstration
- Q&A session