; Course: IDMP - what you need to do NOW
2022-02-17 2022-02-17 , Online Online, 1.090,- € plus tax Remco Munnik https://www.forum-institut.com/seminar/22022011-idmp-what-you-need-to-do-now/referenten/22/22_02/22022011-course-idmp-what-you-need-to-do-now_munnik-remco.jpg IDMP - what you need to do NOW

This workshop helps you collect, clean and structure all necessary data for IDMP and informs you on ePI (structured electronic product information) - a digitalisation project potentially utilizing IDMP and SPOR

Topics
  • What you need to have implemented by 2023
  • SPOR requirements and status
  • SPOR step 1 / step 2 concept
  • ePI: structured electronic product information
  • Bring your own products - the experts will help you describe them in IDMP
Aims and objectives
EMA will release the EU IDMP Implementation Guide V2.2. by the end of 2021. What are the novelties which you should consider now?

This online seminar will show you how to collect, clean and structure all necessary data, and build efficient project teams for the implementation. Related topics such as SPOR and structured electronic product information will also be addressed in detail.

Be prepared for the final implementation of IDMP!
Who should attend

This meeting is for everyone working with regulatory databases, dealing with XEVMPD, IDMP or SPOR. It will also be useful for those who prepare data for these databases or who are involved in regulatory digitalisation projects.

Course: IDMP - what you need to do NOW

IDMP - what you need to do NOW

EU IDMP Implementation Guide V2.2 will be released by the end of 2021

Benefits
  • Two IDMP/SPOR experts
  • Bring your products to discuss your challenges
  • Authority and industry know-how combined
  • We are following the IMI quality criteria

Webcode 22022011

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

17.02.2022

17.02.2022

Period

09:00 - 17:00 seminar; You may dial ...

09:00 - 17:00 seminar; You may dial in 30 min. before the session
Venue

Online

Online

Fee
Ihr Ansprechpartner

Dr. Henriette Wolf-Klein
Head of Department

+49 6221 500-680
h.wolf-klein@forum-institut.de

Details

This workshop helps you collect, clean and structure all necessary data for IDMP and informs you on ePI (structured electronic product information) - a digitalisation project potentially utilizing IDMP and SPOR

Topics
  • What you need to have implemented by 2023
  • SPOR requirements and status
  • SPOR step 1 / step 2 concept
  • ePI: structured electronic product information
  • Bring your own products - the experts will help you describe them in IDMP
Aims and objectives

EMA will release the EU IDMP Implementation Guide V2.2. by the end of 2021. What are the novelties which you should consider now?

This online seminar will show you how to collect, clean and structure all necessary data, and build efficient project teams for the implementation. Related topics such as SPOR and structured electronic product information will also be addressed in detail.

Be prepared for the final implementation of IDMP!

Who should attend

This meeting is for everyone working with regulatory databases, dealing with XEVMPD, IDMP or SPOR. It will also be useful for those who prepare data for these databases or who are involved in regulatory digitalisation projects.

Detailed programme

09:00 - 17:00 seminar; You may dial in 30 min. before the session

09:00

Introduction round
  • Reconciling participants' expectations with the programme

09:15

Georg Neuwirther

IDMP introduction, rationale and implementation status
  • ISO IDMP: rationale and implementation status
  • ISO IDMP essentials - data structure and IDs: Pharmaceutical Product Identifier (PhPID), Medicinal Product Identifier (MPID), Packaged Medicinal Product Identifier (PCID)
  • ISO IDMP and its potential use in telematics projects (DADI, PMS, ePI, ..)

10:25

Is the IDMP rationale and implementation clear? Short break to review and formulate additional questions

10:40

Georg Neuwirther

IDMP and SPOR: How are they related?
  • SPOR requirements and status

11:00 Coffee break


11:15

Remco Munnik

IDMP EU Implementation Guide V2
  • Data elements as requested for iteration 2 - review of the mandatory data elements, including an evaluation of the source and data management of these fields
  • Which medicinal product information will be submitted in the new format?
  • Pharmaceutical and medicinal products
  • Marketing authorisation information
  • Therapeutic (product) indication
  • Ingredients
  • Packaged Medicinal Product Identifier (PCID)
  • Technical specifications on structure and format
  • Migration from XEVMPD to PMS

12:00

IDMP Implementation Guide: Is everything clear? Short break to review and formulate additional questions

12:15

Remco Munnik

IDMP practical implementation
  • Industry point of view

12:45 Lunch break


13:30

Remco Munnik, Georg Neuwirther

Interactive session: Bring your products and share them virtually
  • Describing medicinal products in IDMP, using examples submitted by participants beforehand

14:45 Coffee break


15:00

Remco Munnik

Collecting, cleaning and structuring data: the most urgent things to do
  • Regulatory / PV / Production data

15:30 Wrapping up the urgent things to do. Short break to review and formulate additional questions


15:45

Remco Munnik

Building project teams to process IDMP/SPOR implementation
  • Responsibilities, duties and project leadership

16:10 Coffee break


16:15

Remco Munnik, Georg Neuwirther

The next steps
  • ePI - structured electronic product information: A digitalisation project potentially utilising IDMP and SPOR

17:00 End of seminar


Your benefit

This is why you should attend:

  • Two IDMP and SPOR experts share their knowledge with you
  • Authority and industry expertise in a single seminar
  • Submit your own products and have them described in IDMP
  • Interactive online sessions to review your most urgent queries and things to do
  • Expert advice

FAQs/What are the system requirements?

You need a reliable Internet connection and a browser. The following Windows browsers are applicable:

  • Internet Explorer 8 onwards
  • Mozilla Firefox
  • Google Chrome

_______________

We recommend you use the Zoom app to connect with your mobile device.
You will need a headset, loudspeakers or a telephone for audio.

_______________

Can I test my equipment beforehand?
Yes, you can check whether everything will work properly on the day of your online training.
Just click the following link to run a test: https://zoom.us/test

_______________

Do I have to use a headset for the online seminar?
No. In addition to all popular microphones and loudspeakers, Zoom also supports dial-in access by telephone. However, working with a headset is much more convenient for online seminars.

How does an online seminar work?

The Zoom webcasts 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, using the chat function.

1. You will receive brief instructions on how to use Zoom online seminars 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. Use the chat function to ask questions.

The benefits of an online seminar

  • Attend the webcasts in all comfort, from wherever you like
  • There are no travel and accommodation costs
  • Ask questions live, using the chat function

e-Learning: Common Technical Document & eCTD

Do you lack CTD/eCTD expertise (including CMC know how for CTD module 3)? Then, we would recommend the 'Common Technical Document & eCTD' e-learning programme.

This e-learning programme will provide you with detailed knowledge on the structure and content of the (electronic) common technical document - the only valid dossier format for marketing authorisation applications for human pharmaceuticals in the ICH region.

It will address full as well as abridged dossier application formats, enabling participants to select the data necessary for each application type. Module 3 requirements will be addressed in depth (drug substance and drug product data requirements).

E-learning principles

The e-learning programme 'Common Technical Document & eCTD' comprises four didactic modules that include videos in which the experts Lidia Cánovas and Michael Schaub shares their 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 four modules and passed a final 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 "IDMP - what you need to do NOW" by clicking '"Register"'. You will receive a €100 discount if you also book the e-learning programme (you will be billed €490 + local VAT rather than €590 + local VAT).

This distinguishes our events

Course content: 85 % of the participants’ feedback was very good or good. (December 2019)

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Abbreviations, Glossary
Quality guaranteed!

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

Details
More on our quality criteria

Testimonials


Informativ, empfehlenswert


Needful event


Very interessted and helpfull for the future. This Seminar is a good start for IDMP entries


Interesting


Relevant