2024-02-28 2024-02-28 , online online, 490 € zzgl. MwSt. Ingrid Prieschl https://www.forum-institut.de/seminar/24122643-e-learning-eu-variation-system-and-procedures/referenten/24/24_12/24122643-e-learning-eu-variation-system-procedures_prieschl-ingrid.jpg e-Learning: EU Variation System and Procedures

This e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU.

Topics
  • Module 1: Overview of the EU law and Guidelines
  • Module 2: Classification of Variations
  • Module 3: Procedural Aspects of Variations
  • Module 4: Grouping and Worksharing
  • Module 5: Application Form et cetera
  • Bonus material - Module 5a: Live recording of a webcast on the electronic submission of variations (German language)
  • Module 6: Other Post-Authorisation Procedures


Who should attend
This e-learning course is intended for anyone working on variations, classifying or submitting them to the relevant agency, particularly those involved in regulatory affairs.
Aims and objectives
This e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU. It includes both procedural and contentual topics.

Upon completion, you will be conversant with the key principles of variation submission and have a good starting basis to work in this field.

This e-Learning was developed in December 2019 and updated 2023.

NEW: bonus material - live recording of a webcast on the electronic submission of variations (German language from March 2023)
Your benefit

  • Up-to-date expert knowledge & flexibility in location and timing
  • Get an overview of the EU law and guidelines
  • All you need to know on variation procedures
  • Options to test your knowledge and personal certifi cate
  • All on an intuitive learning platform

e-Learning: EU Variation System & Procedures

e-Learning: EU Variation
System & Procedures

Benefits
  • Up-to-date expert knowledge
  • Flexibility in location and timing
  • You establish your own learning speed
  • Tests and feedback
  • Certificate of completion
  • Compatibility with mobile devices

Webcode 24122643

Jetzt buchen

JETZT Buchen

Referent


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Termin

anytime

anytime

Zeitraum

Veranstaltungsort

online

online

Gebühr
Your contact

Dr. Rebekka Bitsch
Conference Manager

+49 6221 500-565
r.bitsch@forum-institut.de

Details

This e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU.

Topics

  • Module 1: Overview of the EU law and Guidelines
  • Module 2: Classification of Variations
  • Module 3: Procedural Aspects of Variations
  • Module 4: Grouping and Worksharing
  • Module 5: Application Form et cetera
  • Bonus material - Module 5a: Live recording of a webcast on the electronic submission of variations (German language)
  • Module 6: Other Post-Authorisation Procedures


Who should attend
This e-learning course is intended for anyone working on variations, classifying or submitting them to the relevant agency, particularly those involved in regulatory affairs.

Aims and objectives

This e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU. It includes both procedural and contentual topics.

Upon completion, you will be conversant with the key principles of variation submission and have a good starting basis to work in this field.

This e-Learning was developed in December 2019 and updated 2023.

NEW: bonus material - live recording of a webcast on the electronic submission of variations (German language from March 2023)

Your benefit

  • Up-to-date expert knowledge & flexibility in location and timing
  • Get an overview of the EU law and guidelines
  • All you need to know on variation procedures
  • Options to test your knowledge and personal certifi cate
  • All on an intuitive learning platform

Programm

Module 1: Overview of the EU law and Guidelines
Content:
  • European Union law covering marketing authorisation procedures
  • Variation Regulation and guidance documents: Scope of 1234 / 2008 EC and 712 / 2012 / EC; EMA and HMA guidance documents
Learning objectives: After having passed this module you can
  • understand the principles of the European law covering Marketing Authorisation procedures including variations
  • you know which guidance documents are applicable for variations and where you can find

Module 2: Classification of Variations
Content:
  • Category of variations and decision tree
  • Recommendation on unforeseen variations (Article 5)
  • Types of variations: Type IA / IAIN; Type IB; Type II
  • Extensions of marketing authorisations
  • Pre-submission query service
Learning objectives: After having passed this module
  • you will be able to differentiate between the types of variations
  • understand what recommendations according to Article 5 are
  • gain insight into the documentation requirements of the applications
  • you know what an extension application entails

Module 3: Procedural Aspects of Variations
Conten:
  • Centralised and mutual recognition variation procedure: Type IA / IAIN; Type IB; Type II
  • Variation milestone dates
  • Urgent safety restrictions
Learning objectives: After having passed this module
  • you understand the procedural aspects of the variation and with regards to timelines
  • you know when to implement the change
  • gain insight into the milestone dates for the variations
  • understand what an Urgent Safety Restriction is

Module 4: Grouping and Worksharing
  • Legal context and definitions
  • Grouping
  • Worksharing

Module 5: Application form et cetera
  • Electronic application form; data on medicines - SPOR
  • Cover letter
  • eCTD requirements
  • Editorial changes

Module 5a: Bonus material (in German)
recording of the webcast "Elektronische Einreichung von Variations"
  • current PLM and eAF creation experiences

Module 6: Other Post-Authorisation Procedures
  • Article 61(3) notifications
  • Marketing authorisation validity
  • Marketing status report and marketing cessation
  • Renewal; Post-Authorisation Measures (PAMs)
  • Repeat-Use procedure; marketing authorisation transfer; change of RMS
  • Referral procedures

Trailer

e-Learning: EU Variation System & Procedures

Here you can get a brief insight into the e-Learning EU Variation System & Procedures.

Principles

Content

The e-learning programme 'EU Variation System & Procedures' comprises six didactic modules that include videos in which the expert Ingrid Prieschl shares her expertise with you. You can also download and print the corresponding presentation documents.

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

Once you have completed the six 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.

Your benefits

Upon completing this programme, you will:

  • be able to classify and group variations;
  • be knowledgeable of variation submission
  • be able to handle the lifecycle of your product efficiently

You will receive a certificate after having completed the six modules and successfully passed the online multiple-choice tests.

How does it work?

1. Register for an e-learning programme on our website.

2. You will receive an email with your login data for our learning platform.

3. Log in to start your e-learning programme.

4. Complete your e-learning modules at your own pace.

5. Finalise the modules with a multiple-choice test.

6. Once you have successfully completed the test, you will be awarded a certificate, which you can print out.

Please try out the demo versions of our e-learning programmes free of charge to get an idea of our learning environment.

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Modules

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Trailer EU Variation System & Procedures

Watch the trailer for our e-Learning programme "EU Variation System & Procedures".

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Trailer e-Learning EU Variation System & Procedures
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