2024-11-21 2024-11-21 , online online, 1,290 € zzgl. MwSt. Dr. Christina Juli https://www.forum-institut.de/seminar/25022515-global-variations-and-lifecycle-management/referenten/25/25_02/25022515-webcast-series-pharma-global-variations-lifecycle-management_juli-christina.jpg Global variations and lifecycle management

Global variations and lifecycle management - covering key regions: USA, Asia (China, Japan, South Korea), LATAM (Central America, Brazil), and Gulf Cooperation Council (GCC). Take this opportunity to discuss your specific daily business challenges with our experts and network with peers to see how others approach similar issues!

Topics
  • Strategic Planning for Variation Submissions
  • Lifecycle Management Challenges
  • Global CMC Strategy & Regulatory Overview
  • Collaborating with Affiliates/Local Partners
  • Key Submission Formats & Requirements Globally


Who should attend
This webcast series is designed for professionals involved in global lifecycle management. It is especially beneficial for employees in Regulatory Affairs, CMC, and Quality Assurance.

Please note that a basic understanding of the EU variations system is required for this seminar.
Aims and objectives
This webcast series, delivered in four sessions of two hours each, provides an in-depth understanding of the complexities in global lifecycle management.

Our highly experienced speakers will explain how to plan and implement variations on a global scale and collaborate effectively with local partners on ongoing lifecycle responsibilities. The focus is on key regions: the USA, Asia (China, Japan, South Korea), LATAM (Central America and Brazil), and the Gulf Cooperation Council (GCC).
Practical examples will cover both small and large molecule product classes.

By the end of this webcast series, you will be equipped to manage global lifecycle processes efficiently.
Your benefit

  • Meet our industry and consultancy experts, ready to share their in-depth knowledge with you!
  • Gain practical lifecycle management expertise for essential markets!
  • Easily integrate the webcast sessions into your daily work routine!
  • Missed a live session? No worries! Benefit from the recording, available after each webcast!

Webcast series - Global variations and lifecycle management

Global variations and lifecycle management

Strategies for Effective Global Lifecycle Management Across Key Regulatory Regions

Benefits
  • First-hand information
  • Submit your questions prior to the training
  • 4 webcasts à 2h: Easily fit into your work routine
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 25022515

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Referenten


Alles auf einen Blick

Termin

25/02/-25/03/2025

25/02/-25/03/2025

Zeitraum

25th February, 11th, 18th and 25th March 2025
live webcast from 10:00 am - 12:00 pm
You may dial in 30 minutes before the training starts

25th February, 11th, 18th and 25th March 2025
live webcast from 10:00 am - 12:00 pm
You may dial in 30 minutes before the training starts
Veranstaltungsort

online

online

Downloads
Gebühr
Your contact

Verena Planitz
Conference Manager

+49 6221 500-655
v.planitz@forum-institut.de

Details

Global variations and lifecycle management - covering key regions: USA, Asia (China, Japan, South Korea), LATAM (Central America, Brazil), and Gulf Cooperation Council (GCC). Take this opportunity to discuss your specific daily business challenges with our experts and network with peers to see how others approach similar issues!

Topics

  • Strategic Planning for Variation Submissions
  • Lifecycle Management Challenges
  • Global CMC Strategy & Regulatory Overview
  • Collaborating with Affiliates/Local Partners
  • Key Submission Formats & Requirements Globally


Who should attend
This webcast series is designed for professionals involved in global lifecycle management. It is especially beneficial for employees in Regulatory Affairs, CMC, and Quality Assurance.

Please note that a basic understanding of the EU variations system is required for this seminar.

Aims and objectives

This webcast series, delivered in four sessions of two hours each, provides an in-depth understanding of the complexities in global lifecycle management.

Our highly experienced speakers will explain how to plan and implement variations on a global scale and collaborate effectively with local partners on ongoing lifecycle responsibilities. The focus is on key regions: the USA, Asia (China, Japan, South Korea), LATAM (Central America and Brazil), and the Gulf Cooperation Council (GCC).
Practical examples will cover both small and large molecule product classes.

By the end of this webcast series, you will be equipped to manage global lifecycle processes efficiently.

Your benefit

  • Meet our industry and consultancy experts, ready to share their in-depth knowledge with you!
  • Gain practical lifecycle management expertise for essential markets!
  • Easily integrate the webcast sessions into your daily work routine!
  • Missed a live session? No worries! Benefit from the recording, available after each webcast!

Detailed programme

25th February, 11th, 18th and 25th March 2025
live webcast from 10:00 am - 12:00 pm
You may dial in 30 minutes before the training starts

Dr Christina Juli

25 February 2025 EU variations vs US variations
  • EU: Type IA, IB and Type II (including examples)
  • US variation: Annual report, CBE-30 and PAS (including examples)
  • Lifecycle management: Strategic planning of variation submission
  • Challenges during lifecycle management

Q&As


End of webcast


Dr Christina Juli

11 March 2025 Asian variations with a focus on China, Japan and South Korea
  • Global CMC strategy
  • Lifecycle management in Asian countries
  • Working with affiliates/local partners

Q&As


End of webcast


Ivette Camarasa Magrina

18 March 2025 LATAM variations
  • Regulatory framework
  • Lifecycle management and working with affiliates/local partners
  • Submission format

Q&As


End of webcast


Laia Canamero Ruiz

25 March 2025 GCC variations
  • Regulatory framework
  • Lifecycle management and working with affiliates/local partners
  • Submission format

Q&As


End of webcast


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 v.planitz@forum-institut.de.

Benefits of a FORUM Institut training course

FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.

  • Live and interactive learning on our Learning Space training platform
  • A platform with many features: events rooms, chat, course agendas and documents, surveys, workshop rooms and much more
  • Easy surveys with Slido
  • ‘Deluxe’ chat: group chats, one-to-one chats, one-to-one video chats
  • A central repository for documents and media
  • Other services and apps such as Padlet and Mentimeter available directly on the platform
  • The perfect marriage of teaching methods and technology
  • High level of interactivity with plenty of opportunity for questions
  • Continuous support throughout the event to ensure the most effective learning
  • Free technical pre-meeting to start off your training on the right foot

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.

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.

This distinguishes our events

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We are now officially certified to ISO 9001 and ISO 21001 standard.

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