Global variations and lifecycle management

Strategies for Effective Global Lifecycle Management Across Key Regulatory Regions

  • 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
Global variations and lifecycle management

Serie (abgeschlossen)

Ab 1.290,00 € zzgl. MwSt.
Leistungen & Ablauf

Buchungsdetails

Serie (abgeschlossen)

Ab 1.290,00 € zzgl. MwSt.
Leistungen & Ablauf

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!

Your speakers

Dr. Christina Juli

Dr. Christina Juli

Boehringer Ingelheim International GmbH
Biberach an der Riss, GERMANY

Head of CMC, CCM RA Office NBE
Dr. Christina Juli studied pharmacy at the University of Wuerzburg, Germany. After her PhD thesis in…

Carmen Bas Jiménez

Carmen Bas Jiménez

Asphalion, S.L., Barcelona, SPAIN

Senior Regulatory Affairs Officer
Carmen Bas Jiménez is a pharmacist working as a Senior Regulatory Affairs Officer at Asphalion, within the Life Cycle Management team.…

Maria Roncero Lendinez

Maria Roncero Lendinez

Asphalion, S.L., Barcelona, SPAIN

Regulatory Affairs Consultant
María Roncero Lendínez studied Pharmacy from the Universidad Complutense de Madrid and has over nine years of experience in the…

What to Expect

  • 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.

Objective of the Event

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!

Programme

each day
from 10:00 am - 12:00 pm

10:00 - 12:00

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

10:00 - 12:00

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

10:00 - 12:00

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

10:00 - 12:00

Gulf Cooperation Council (GCC) variations
  • Regulatory framework
  • Lifecycle management and working with affiliates/local partners
  • Submission format
10:00 - 12:00

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
10:00 - 12:00

Asian variations with a focus on China, Japan and South Korea

  • Global CMC strategy
  • Lifecycle management in Asian countries
  • Working with affiliates/local partners
10:00 - 12:00

LATAM variations

  • Regulatory framework
  • Lifecycle management and working with affiliates/local partners
  • Submission format
10:00 - 12:00

Gulf Cooperation Council (GCC) variations

  • Regulatory framework
  • Lifecycle management and working with affiliates/local partners
  • Submission format

More Options

Are you interested in broadening your regulatory horizon? This seminar can be booked as part of the qualification course 'Regulatory Affairs Manager', which provides a structured introduction to regulatory affairs while allowing you to set your own focus areas. It combines guided self-study with interactive online seminars to build a solid understanding of regulatory requirements for human medicinal products. Core principles of EU marketing authorisation form the foundation, with the option to deepen your knowledge through additional EU and/or global regulatory affairs online trainings.

Search for the webcode 60012501 on our website for more information and registration or simply click on the link below:
Qualification Course Regulatory Affairs Manager

By booking the qualification course you will save up to 30% compared to individual bookings.

Downloads

Request the documents using our form.

Prospekt

Brochure

Abbreviations Drug-Regulatory-Affairs and CMC

Weitere Informationen


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.

In-house Offers - On-site and Online

We also conduct this seminar exclusively for your company - individually tailored to your requirements, flexible scheduling and available as either on-site or online format. Contact us and we will prepare a customized offer for you.

Request a quote

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Further Information

Whitepaper: MA and lifecycle management in Japan

Whitepaper: MA and lifecycle management in Japan

This whitepaper describes what you need to keep in mind when it comes to specific Japanese CMC requirements for…

Details
In-house seminars

In-house seminars

Our programmes are also available for in-house training. Just contact us!

Details
We guarantee the highest quality

We guarantee the highest quality

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

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Your Contact Person

We are happy to advise you personally and individually.

Our further education offerings are comprehensive. We are happy to personally match your requirements with our offerings. Let our further education experts advise you and contact us today.
Verena Planitz

Verena Planitz
Conference Manager
+49 6221 500-655
v.planitz@forum-institut.de