2020-12-08 2021-12-09 , Online Online, 1.790,- € zzgl. MwSt. Christine Hirt https://www.forum-institut.de/seminar/21122458-esubmission-management-in-europe/51/N/0/0/0/referenten/21/21_12/21122458-online-course-pharma-esubmission-management-in-europe_hirt-christine.jpg eSubmission Management in Europe

The course provides practical, hands-on experience in eCTD specifications, eSubmission requirements and data integrity for IDMP, SPOR and XEVMPD. Save your place in our virtual zoom seminar room.

Topics
  • eSubmission: Regulatory update
  • XEVMPD, IDMP: Current requirements, transition path
  • Efficient data management/maintenance and data integrity
  • Regulatory information management
  • eCTD around the world
  • IT know-how for eSubmission managers
Aims and objectives
This online seminar will familiarise you with electronic submission requirements in regulatory affairs and enable you to further professionalise your submission management. It will also identify the data you need for IDMP and SPOR and show you how to optimise your data integrity management.
Who should attend

This online seminar is aimed at all specialists and managers entrusted with the electronic submission of marketing-authorisation-related documents or responsible for the regulatory databases.
Basic eCTD knowledge is advantageous.

Online Course eSubmission Management in Europe

eSubmission Management in Europe

- Online training -

Benefits
  • Meet the experts!
  • Take away practical hints and tips
  • Online format: Modern, flexible, interactive
  • Optional e-Learning bookable
  • We are following the IMI quality criteria

Webcode 21122458

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

08. - 09.12.2021

08. - 09.12.2021

Zeitraum

both days 9:00 am - 5:00 pm

both days 9:00 am - 5:00 pm
Veranstaltungsort

Online

Online

Gebühr
Ihr Ansprechpartner

Dr. Birgit Wessels
Conference Manager

+49 6221 500-652
b.wessels@forum-institut.de

Details

The course provides practical, hands-on experience in eCTD specifications, eSubmission requirements and data integrity for IDMP, SPOR and XEVMPD. Save your place in our virtual zoom seminar room.

Topics
  • eSubmission: Regulatory update
  • XEVMPD, IDMP: Current requirements, transition path
  • Efficient data management/maintenance and data integrity
  • Regulatory information management
  • eCTD around the world
  • IT know-how for eSubmission managers
Aims and objectives

This online seminar will familiarise you with electronic submission requirements in regulatory affairs and enable you to further professionalise your submission management. It will also identify the data you need for IDMP and SPOR and show you how to optimise your data integrity management.

Who should attend

This online seminar is aimed at all specialists and managers entrusted with the electronic submission of marketing-authorisation-related documents or responsible for the regulatory databases.
Basic eCTD knowledge is advantageous.

Detailed programme

both days 9:00 am - 5:00 pm

09:00 Welcome and introductory round


09:15

Anjana Pindoria

eSubmission: The future of EU is agile, but what does it mean?
  • Overview of current EU digital programs (SPOR, ePI, DADI, eCTD 4.0, FHIR)
  • The impact on your regulatory processes in the future
  • What is TOM? And why it is important for Industry to start preparing now
  • xEVMPD and SPOR: How the transition will work
  • eCTD submission management
  • eCTD 4.0 overview, points to consider

12:30 Lunch break


13:30

Renato Rjavec

From XEVMPD to IDMP
  • Overview of current XEVMPD and upcoming IDMP requirements
  • Transition path from XEVMPD to IDMP

14:30

Renato Rjavec

IDMP impact on RIM systems
  • The impact of IDMP on RIM systems
  • Key IDMP solution requirements to consider

15:15 Coffee break


15:30

Christine Hirt

Implementation of IDMP: Hands-on tips
  • Preparation of the required data
  • GAP analysis and strategies for IDMP implementation in the enterprise
  • Smart IDMP: What benefits does IDMP bring to my company?
  • Hurdles and issues: Lessons learned
  • Best practice approach and recommendations

16:45 Summary and outstanding questions


17:00 End of training day I


09:00

Sven Harmsen

Regulatory information management
  • Registration planning and tracking
  • Submission management
  • Document management
  • Label management
  • Structured authoring

10:30 Coffee break


10:45

Anjana Pindoria

eCTD around the world: How to keep up with global changes?
  • Challenges of managing global regulatory standards
  • How to manage company changes on a global level
  • The future of eCTD

12:15 Lunch break


13:15

Sven Harmsen

IT know-how for eSubmission managers
  • Role of a business user in IT projects
  • Computer system validation
  • User requirement specification
  • User acceptance testing
  • Lessons learned from IT projects in regulatory affairs
  • Overview of available systems and vendors
  • Cloud systems

14:45 Coffee break


15:00

Sven Harmsen

Data integrity and regulatory compliance including local database, xEVPMD, IDMP and SPOR

16:45 Summary and concluding discussion


17:00 End of training course


More information

Send us your individual questions

Please send us your questions concerning the seminar topics in advance.

We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions at the seminar.

Please send your questions to b.wessels@forum-institut.de

How does an online seminar work?

Our online training courses are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live.

1. You will receive brief instructions on how to use Zoom beforehand.
2. 48 hours before the online seminar, you will receive an email with an access link and a meeting ID.
3. Use a headset, loudspeakers or the telephone for audio.
4. Listen to the speaker and follow the presentation.
5. Feel free to switch from silent to audio mode by yourself any time to ask your questions.

e-Learning: eCTD preparation and submission

Do you need practical expertise in editing essential marketing authorisation documents and compiling an eCTD? Do you need to make a baseline submission and thus seek practical advice?Then, we would recommend the 'eCTD preparation and submission' e-learning programme.

This e-Learning consisting of three recorded webcasts will show you step by step how to develop the relevant documents, compile them and submit an eCTD.

E-learning principles

The online training programme "eCTD preparation and submission" comprises three didactic modules in which the expert share his expertise with you. You can also download and print the corresponding presentation documents.

Each module comprises additional documents (links, guideline texts, etc.) as well as interactive exercises and questions, which help you practise and apply your newly gained knowledge.

Once you have completed the three modules and passed the multiple-choice test, you will be awarded a certificate, which you can print out directly. The e-learning programme should be completed within three months. Try our e-learning programme for free and familiarise yourself with our learning environment.

How to book the e-learning programme in addition to the seminar

Please register for the seminar "eCTD preparation and submission" by clicking '"Register"'. You will receive a €100 discount if you also book the e-learning programme (you will be billed €290 + local VAT rather than €390 + local VAT).

This distinguishes our events

Overall impression: 100% of the participants’ feedback was very good or good. (June 2019)

Course content: 100% of the participants’ feedback was very good or good. (June 2019)

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Testimonials

Hear from our past delegates and sponsors and learn more about the events.

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Testimonials
Quality guaranteed!

Your feedback produced as result of 1.7 in 2020. Thank you!

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More on our quality criteria

Testimonials

This is what participants in June 2019 liked most about the event.
The speaker have lot of experience and are updated on the latest news especially about eCTD.


The possibility to exchange experience and to ask / receive suggestions and how to manage particular siutuations / cases.


Very good organisation. High quality of speakers.


This event covered all relevant topics around eSubmisson.

Comment of former participants (June 2019).
Well organised. No kind os issues at all. Staff full availabilty. Speakers updated on the last changes on this matter.

Dr.ssa Silvia Immediato.

Alfasigma S.p.a


Good update on regulatory information (eSubmission, XEVMP, IDMP). Good speakers.