2024-02-27 2024-02-27 , online online, 1,250 € zzgl. MwSt. Dr. Christina Juli https://forum-institut.de/seminar/24022452-global-variations-and-lifecycle-management/referenten/24/24_02/24022452-webcast-series-pharma-global-variations-lifecycle-management_juli-christina.jpg Global variations and lifecycle management

Global variations & lifecycle management - regions covered: USA, Asia (China, Japan, South Korea), LATAM (Central America, Brazil), and GCC; take the chance and discuss your individual daily business challenges with our experts and your colleagues (How others do it!?)!

Topics
  • Concept: Four weekly live webcasts à 2 hours with longtime experienced speakers
  • Regions covered: USA, Asia, LATAM and GCC
  • Your benefits: Possibility to directly interact with the speaker; You will receive a certificate after each session; You are unable to attend one of the sessions? Benefit from the recording of each webcast!


Who should attend
This webcast series is aimed at anyone involved in global lifecycle management.
Employees in Regulatory Affairs/CMC and Quality assurance will particularly benefit from the event.

Basic knowledge of the EU variations system is a prerequisite for the seminar.
Aims and objectives
This webcast series provides you with a thorough understanding of the challenges of global lifecycle management.

Our experts explain how to plan and roll out variations "globally" and how to collaborate with local partners on further lifecycle duties. The focus is on the following regions: USA, Asia (China, Japan, South Korea), LATAM (Central America and Brazil) and GCC.
Practical examples cover the product classes small and large molecules.

After having attended this webcast series, you will be capable of efficient global lifecycle management.
Your benefit

  • Meet our experts from industry and consulting, who will share in-depth knowledge with you!
  • Obtain practical lifecycle management know-how for key markets!
  • Integrate the webcast sessions conveniently into your daily work routine!
  • Missed a live session? No problem! Make profit from the recording that is available after each individual webcast!

Webcast series - Global variations and lifecycle management

Global variations and lifecycle management

Webcast fee for 4 modules € 1250,--
Option to book a single webcast. Fee € 350,--/module.
Please contact b.wessels@forum-institut.de

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

Webcode 24022452

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

anytime

anytime

Zeitraum

20th and 27th February, 5th and 12th March 2024
live webcast from 10:00 am - 12:15 pm
You may dial in 30 minutes before the training starts

20th and 27th February, 5th and 12th March 2024
live webcast from 10:00 am - 12:15 pm
You may dial in 30 minutes before the training starts
Veranstaltungsort

online

online

Gebühr
Your contact

Dr. Birgit Wessels
Conference Manager

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

Details

Global variations & lifecycle management - regions covered: USA, Asia (China, Japan, South Korea), LATAM (Central America, Brazil), and GCC; take the chance and discuss your individual daily business challenges with our experts and your colleagues (How others do it!?)!

Topics

  • Concept: Four weekly live webcasts à 2 hours with longtime experienced speakers
  • Regions covered: USA, Asia, LATAM and GCC
  • Your benefits: Possibility to directly interact with the speaker; You will receive a certificate after each session; You are unable to attend one of the sessions? Benefit from the recording of each webcast!


Who should attend
This webcast series is aimed at anyone involved in global lifecycle management.
Employees in Regulatory Affairs/CMC and Quality assurance will particularly benefit from the event.

Basic knowledge of the EU variations system is a prerequisite for the seminar.

Aims and objectives

This webcast series provides you with a thorough understanding of the challenges of global lifecycle management.

Our experts explain how to plan and roll out variations "globally" and how to collaborate with local partners on further lifecycle duties. The focus is on the following regions: USA, Asia (China, Japan, South Korea), LATAM (Central America and Brazil) and GCC.
Practical examples cover the product classes small and large molecules.

After having attended this webcast series, you will be capable of efficient global lifecycle management.

Your benefit

  • Meet our experts from industry and consulting, who will share in-depth knowledge with you!
  • Obtain practical lifecycle management know-how for key markets!
  • Integrate the webcast sessions conveniently into your daily work routine!
  • Missed a live session? No problem! Make profit from the recording that is available after each individual webcast!

Detailed programme

20th and 27th February, 5th and 12th March 2024
live webcast from 10:00 am - 12:15 pm
You may dial in 30 minutes before the training starts

Welcome and introduction round


Dr Christina Juli

20 February 2024 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


Welcome and introduction round


Dr Christina Juli

27 February 2024 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


Welcome and introduction round


Ivette Camarasa Magrina

5 March 2024 LATAM variations
  • Regulatory framework
  • Lifecycle management and working with affiliates/local partners
  • Submission format

Q&As


End of webcast


Welcome and introduction round


Laia Canamero Ruiz

12 March 2024 GCC variations
  • Regulatory framework
  • Lifecycle management and working with affiliates/local partners
  • Submission format

Q&As


End of webcast


Workshops

ASPHALION

Asphalion is an international Scientific and RA consultancy company. Founded in 2000, Asphalion offers comprehensive services for Drug Development and RA to Pharma, Biotech and Medical Devices companies. The services range from early development, throughout the registration, until marketing and post-commercialization phases of a product.

ASPHALION



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

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.

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