EU Supply Shortage Management and the ESMP
Including legislative updates on the CMA and the new pharma package
- Intensive training on shortage management
- Update on CMA & pharma legislation
- Recorded live-sessions
- Officially certified according to ISO 9001 and 21001
Serie (abgeschlossen)
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
each from 9:00 a.m. - 12:30 a.m. CET:
Booking details
Serie (abgeschlossen)
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
each from 9:00 a.m. - 12:30 a.m. CET:
Stay up to date on EU supply shortage management: reporting obligations, the Critical Medicines Act and practical ESMP guidance - in two focused half-day sessions.
Your speakers
Frank Dickert
EXTEDO GmbH, Ottobrunn, GERMANY
Senior Business Consultant
After an apprenticeship in the pharmaceutical industry, Frank Dickert graduated with a degree in biochemistry, focussing on bioinformatics and…
Your speaker
Frank Dickert
EXTEDO GmbH, Ottobrunn, GERMANY
Senior Business Consultant
After an apprenticeship in the pharmaceutical industry, Frank Dickert graduated with a degree in biochemistry, focussing on bioinformatics and structural biochemistry. In 2017, Frank Dickert joined EXTEDO's Regulatory Competence Center. Since then, he has been consulting pharmaceutical companies in regulatory business as well as eCTD submissions and IDMP worldwide. He analyzes and optimizes regulatory business processes and document lifecycles with or without software, resolves customer support issues with different eSubmission tools, and offers regulatory consulting regarding the respective tool.
Gabriele Eibenstein M.A.
-requested-
Senior Expert in Regulatory Affairs, Bonn, GERMANY
Senior Expert in Regulatory Affairs
Ms Eibenstein has extensive expertise in European procedural management, heads the specialist field…
Your speaker
Gabriele Eibenstein M.A.
-requested-
Senior Expert in Regulatory Affairs, Bonn, GERMANY
Senior Expert in Regulatory Affairs
Ms Eibenstein has extensive expertise in European procedural management, heads the specialist field "RAS, AM counterfeiting, supply shortages" at BfArM, is the German member of the SPOC Working Party, and is actively involved in shortage management at both national and European levels.
What to Expect
- EU and national shortage monitoring: obligations, reporting criteria and deadlines for MAHs
- Critical Medicines Act (CMA) and the new EU pharmaceutical legislation: impacts on shortage management
- European Shortages Monitoring Platform (ESMP): data structure, monitoring scenarios and use in practice
- Best practices for consistent and reliable data submission, including API-based automated reporting
- Interactive case study
Who Should Attend
This seminar is aimed at regulatory affairs professionals, supply chain managers and other specialists in pharmaceutical companies who are involved in shortage reporting and supply security. It is also relevant for quality assurance, medical affairs and regulatory operations teams working with the ESMP or preparing for the requirements of the Critical Medicines Act.
Participants are expected to have a solid understanding of EU regulatory procedures.
Objective of the Event
This online seminar provides a comprehensive overview of supply shortage management in the EU - from regulatory obligations to practical tools.
In module 1 you will gain a solid understanding of the EU shortage monitoring landscape, including key reporting obligations for MAHs at EU and national level, the role of EMA, NCAs and the SPOC network, and the implications of the Critical Medicines Act and the new EU pharma legislation for shortage management.
In module 2 you will explore the ESMP in depth - its data structure, the three monitoring scenarios and practical guidance on correct data submission, including API-based automated reporting.
Both modules will be recorded and made available to you after the event for flexible review.
Your Benefit
- You gain a clear understanding of the EU regulatory framework for supply shortage management and the reporting obligations of MAHs.
- You receive an up-to-date overview of the Critical Medicines Act and the new EU pharmaceutical legislation and how they affect your shortage management processes.
- You learn how to navigate and use the ESMP effectively, including best practices for data submission and the API interface.
- You consolidate your knowledge through an interactive practical exercise.
Programme
from 9:00-12:30 CET
09:00 - 12:30
Gabriele Eibenstein M.A.
- Background on supply shortage management in the EU
- Monitoring and analysis of medicinal product shortages at EU and EEA level
- Coordination between the EMA, NCAs and pharmaceutical companies
- Key reporting obligations for MAHs, including criteria and deadlines
- Identification of supply-relevant and supply-critical active substances at EU and national level
- Measures in crisis situations and the role of the SPOC network
- Critical Medicines Act and new EU pharmaceutical legislation
- Overview of the EU initiatives to strengthen security of supply
- Impacts on Shortage Management and the ESMP
- Positioning of the CMA within the existing regulatory framework
- Interfaces between Critical Medicines Lists, ESMP reporting and national notification requirements
- Q&A
09:00 - 12:30
Frank Dickert
- Overview of the European Shortages Monitoring Platform (ESMP)§§§Data sources and data structure of ESMP
- Three monitoring scenarios: Normal circumstances, MSSG-led preparedness & Crisis mode
- Internal communication and cooperation with relevant departments
- ESMP Data Submission
- Data set and data presentation
- Guidance for MAHs and NCAs on correct entry of shortage notifications
- Best practices for consistent and reliable data submission
- API interface for automated submission of reports
- Interactive practical exercise
- Q&A
09:00 - 12:30
Module 1: Regulatory Framework and Legislative Updates
Module 1: Regulatory Framework and Legislative Updates
Gabriele Eibenstein M.A.
- Background on supply shortage management in the EU
- Monitoring and analysis of medicinal product shortages at EU and EEA level
- Coordination between the EMA, NCAs and pharmaceutical companies
- Key reporting obligations for MAHs, including criteria and deadlines
- Identification of supply-relevant and supply-critical active substances at EU and national level
- Measures in crisis situations and the role of the SPOC network
- Critical Medicines Act and new EU pharmaceutical legislation
- Overview of the EU initiatives to strengthen security of supply
- Impacts on Shortage Management and the ESMP
- Positioning of the CMA within the existing regulatory framework
- Interfaces between Critical Medicines Lists, ESMP reporting and national notification requirements
- Q&A
09:00 - 12:30
Module 2: Shortage Monitoring in Practice
Module 2: Shortage Monitoring in Practice
Frank Dickert
- Overview of the European Shortages Monitoring Platform (ESMP)§§§Data sources and data structure of ESMP
- Three monitoring scenarios: Normal circumstances, MSSG-led preparedness & Crisis mode
- Internal communication and cooperation with relevant departments
- ESMP Data Submission
- Data set and data presentation
- Guidance for MAHs and NCAs on correct entry of shortage notifications
- Best practices for consistent and reliable data submission
- API interface for automated submission of reports
- Interactive practical exercise
- Q&A
Workshops
Search for the webcode 60012501 on our website for more information and registration or simply click on the link below:
Qualification Course Regulatory Affairs Manager
By booking the qualification course you will save up to 30% compared to individual bookings.
Downloads
Request the documents using our form.
Weitere Informationen
Modular webcast - maximum flexibility
Both modules will be recorded and made available to the participants afterwards.
This gives you the opportunity to revisit the content flexibly and at your own pace or to review specific topics whenever needed. In this way, the training can be integrated smoothly into your working routine. The recordings will be available for up to 90 days after the live sessions.
Free pre-meeting and technology check
You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.
The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.
Access to and procedure for online events
Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.
All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.
On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.
Learn more about our online events here.
Technical requirements
You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.
Our Recommendations
Further Information
Your Contact Person
We are happy to advise you personally and individually.
Jean-Marie Bayhurst
Conference Manager
+49 6221 500-685
j.bayhurst@forum-institut.de