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

• Recording from the webinar
• Presentation from the webinar

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.

• Recording from the training session

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

• Presentation from the training
• Recording from the training session

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.

• Recording from the training session
• Presentation from the training webinar
• Questions and Answers from the session

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.

• Recording from the webinar
• Questions and Answers from the eAF go-live session

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.

• Recording from the webinar
• Presentation from the training webinar
• Questions and Answers from training webinars

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.

• Recording from the webinar
• Presentation from the webinar

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.

• Recording from the webinar
• Presentation from the webinar
• Q&A from the webinar

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. 

• Presentation from the webinar
• Recording from the webinar
• DADI-PMS What will happen at go-live Q&A (June 2022)

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.

• Recording from the webinar
• Presentation from the webinar

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.

• Recording from the webinar
• Presentation from the webinar
• Variation FHIR mapping and examples (Draft version from January 2022)

Q4 - Quarterly system demo - (19 December 2023)

This is the fourth system demo of 2023, the eighth ever held by EMA as part of its Agile transformation.

A system demo provides an integrated view on what has been built in the past 3 months (Programme Increment). It is the opportunity for the audience to give instant feedback to the Agency's development teams to build the right solution.
EMA will demonstrate developments with several products including:

• EU Network Training Centre (EU NTC) Engagement Portal
• Critical Medical Devices Shortages (CMDS)
• Veterinary Union Pharmacovigilance (UPhV)Database
• Paediatrics Procedure
• Real World Metadata Catalogues (RWMC)
• Scientific Explorer for Scientific Advice
• TRIP (Horizon Scanning)
• Electronic Application Form (eAF)
• Product Management Service (PMS)
• Product User Interface (UI)
• Electronic Product Information (ePI)
• Regulatory Procedure Management (RPM)
• Veterinary Union Product Database (UPD)

Recording from the webinar

 

Q3 - Quarterly system demo - (21 September 2023)

This is the third system demo of 2023, the seventh ever held by EMA as part of its Agile transformation.

A system demo is an event held at the end of a programme increment (a three-month period of work) to demonstrate the developments achieved in that period and collect stakeholder feedback.

Participants have the opportunity to review what has been delivered, give feedback and ask questions on future product increments (planned chunks of work on the final system).

EMA will demonstrate developments with several products including:

• Critical Medical Device Shortages (CMDS)
• European Shortages Monitoring Platform (ESMP) 
• Priority Medicines (PRIME)
• Real World Metadata Catalogues (RWMC)
• Clinical Trial Navigator (CTN) (proof of concept)
• Electronic Application Form (eAF)Product Management Service (PMS)
• Product User Interface (UI)
• Electronic Product Information (ePI)
• Regulatory Procedure Management (RPM)
• Veterinary Union Product Database (UPD)
• Improved regulatory user journey for EMA stakeholders

Recording from the webinar

 

Q2 - Quarterly system demo - (22 June 2023)

This is the second system demo of 2023, the sixth ever held by EMA as part of its Agile transformation. 

A system demo is a ceremony held at the end of a programme increment (a three-month period of work) to demonstrate the developments achieved in that period and collect stakeholder feedback.

Participants have the opportunity to review what has been delivered, comment and ask questions on future product increments (planned chunks of work on the final system).

EMA will demonstrate developments with several products including:

• Priority Medicines (PRIME),
• Real World Metadata Catalogues (RWMC)
• Electronic Application Form (eAF)
• Product Management Service (PMS),
• Product User Interface (UI),
• Electronic Product Information (ePI),
• Regulatory Procedure Management (RPM),
• Improved regulatory user journey for EMA stakeholders,
• Critical Medical Devices Shortages (CMDS),
• Veterinary Union Pharmacovigilance (UPhV) Database.

Recording from the webinar

 

Q1 - Quarterly system demo - (22 March 2023)

This is the first system demo of 2023, the sixth ever held by EMA as part of its Agile transformation. 

A system demo is a ceremony held at the end of a programme increment (a three-month period of work) to demonstrate the developments achieved in that period and collect stakeholder feedback.

Participants have the opportunity to review what has been delivered, comment and ask questions on future product increments (planned chunks of work on the final system).

EMA will demonstrate developments with several products including:

• Electronic Application Form (eAF)
• Product Management Service,
• Product User Interface (UI),
• Electronic Product Information (ePI),
• Regulatory Procedure Management (RPM),
• Union Product Database (UPD),
• Presentation - Session 1: Monitoring and mitigating shortages of medicines and devices (J. Ferreira, EMA),
• Critical Medical Devices Shortages (CMDS),
• Veterinary Union Pharmacovigilance (UPhV) Database, and
• Experts Management Tool.

Recording from the webinar

 

Q4 - Quarterly system demo - (21 December 2022)

This is the fourth system demo of 2022, the fifth ever held by EMA as part of its Agile transformation. 

A system demo is an event held at the end of a programme increment (a three-month period of work) to demonstrate the developments achieved in that period and collect stakeholder feedback.

Participants have the opportunity to review what has been delivered, comment and ask questions on future product increments (planned chunks of work on the final system).

EMA will demonstrate developments with its eAF/DADI Human Variation Form Electronic Product Information (ePI), Product Management Service, Emergency Task Force support, Inspections/Parallel distribution, Veterinary Union pharmacovigilance (UPhV) Database and Experts Database.

Recording from the webinar

 

Q3 - Quarterly system demo - (28 September 2022)

This is the third system demo of 2022, the fourth ever held by EMA as part of its Agile transformation. 

A system demo is an event held at the end of a programme increment (a three-month period of work) to demonstrate the developments achieved in that period and collect stakeholder feedback.

Participants have the opportunity to review what has been delivered, comment and ask questions on future product increments (planned chunks of work on the final system).

EMA will demonstrate developments with its DADI project Product Management Service, Electronic Product Information (ePI), Emergency Task Force Support, Veterinary Signal Management, Inspections, Parallel distribution and Medicines Shortages.

Recording from the webinar

 

Q2 - Quarterly system demo (including DADI) - (28 June 2022)

This is the second system demo of 2022, the third ever held by EMA as part of its Agile transformation. 

A system demo is an event held at the end of a programme increment (a three-month period of work) to demonstrate the developments achieved in that period and collect stakeholder feedback.

Participants have the opportunity to review what has been delivered, comment and ask questions on future product increments (planned chunks of work on the final system).

EMA will demonstrate developments with its DADI project Product Management Service, Emergency Task Force Support and Medicines Shortages.

Recording from the webinar

 

Q1 - Quarterly system demo (including DADI & PMS) - (15 March 2022)

This is the first system demo of 2022, the second ever held by EMA as part of its Agile transformation. 

EMA will demonstrate developments with its DADI projectand PMS service. 

Recording from the webinar