Purpose and context

 

This is a dedicated page, serving as a comprehensive repository of essential links to Guidance Documents and Training Videos on the use of the PLM Portal for the new electronic Application Form (eAF).

 
Explore these resources to gain valuable insights and practical knowledge, empowering your understanding of the PLM Portal for eAFs.
 

Guidance documents

 

Training videos

 

Training sessions

 

Webinars

 

2023

Update on Human Variations web based eAF implementation on PLM Portal (6 November 2023)

This is a joint eAF-PMS webinar intended for business and technical audiences interested in the use of Human Variations web-based eAFs

 

Human Variations web-based eAF Form training session (2 February 2023)

This event is a training webinar for industry and national competent authorities’ stakeholders wishing to learn more about the use of the new PLM portal and web forms features after the go-live.

 

2022

Human Variations web-based eAF Form training session (15 December 2022)

 

Human Variations web-based eAF Form training session (8 November 2022)

This event is a training webinar for industry and national competent authorities’ stakeholders wishing to learn more about the use of the new PLM portal and web forms features after the go-live.

 

Human Variations Form go-live Q&A session (27 October 2022)

This event is a Q&A webinar aiming at addressing questions from industry and national competent authorities’ stakeholders concerning the release of the web-based variations eAF for Human CAPs.

 

eAF Q&A clinic recordings

These Q&A Clinic sessions aim at addressing questions from users of PLM portal and web forms users after the release of the electronic application forms (eAF) 

  • Human Variation eAF Q&A Clinic - session 7 (22 January 2023)

  • Human Variation eAF Q&A Clinic - session 6 (17 January 2023)

  • Human Variation eAF Q&A Clinic - session 5 (19 December 2022)

  • Human Variation eAF Q&A Clinic - session 4 (14 December 2022)

  • Human Variation eAF Q&A Clinic - session 3 (access management) (29 November 2022)

  • Human Variation eAF Q&A Clinic - session 2 (22 November 2022)

  • Human Variation eAF Q&A Clinic - session 1 (15 November 2022)

 

DADI PDF electronic application forms eAF training webinar (2 September 2022)

This event is a training webinar for industry and national competent authorities’ stakeholders wishing to learn more about access management aspects related to the new dedicated portal and the procedure to fill in a web-based eAF at go-live.

 

DADI PDF electronic application forms (eAF) training webinar (26 July 2022)

This event is a training webinar for industry and national competent authorities’ stakeholders wishing to learn more about access management aspects related to the new dedicated portal and the procedure to fill in a web-based eAF at go-live.

 

DADI Q&A Webinar "Variations form for Human Medicinal Products Go-live" (12 July 2022)

This event is a dedicated Q&A webinar for business and technical audiences from industry and national competent authorities to address questions about the revised scope of the DADI October Go-live.

 

DADI-PMS Webinar “Variations form for human medicinal products - What will happen at go-live” (16 May 2022)

This event is a joint DADI-PMS webinar for business and technical audiences from industry and national competent authorities wishing to learn more about what will happen when the DADI web-based form for human medicinal products will go live. 

 

Introducing DADI: webinar on the digital application dataset integration (DADI) network project to replace electronic application forms (18 January 2022)

This webinar is for stakeholders from the human & veterinary medicines industry and national competent authorities wishing to learn more about DADI roadmap & objectives for CAPS & NAPS, DADI’s connection to EMA’s Regulatory Business Optimisation, and main changes introduced by DADI and impacts for the pharmaceutical industry.

Digital application dataset integration (DADI) - common factors in the Fast Healthcare Interoperability Resources (FHIR) data standard for Article 57(2) and electronic application forms (eAF) (25 January 2022)

This webinar is for technical experts from industry and national competent authorities wishing to learn more about the design of the FHIR message for the first form to be updated: Human Variations.