2024-04-22 2024-04-22 , online online, 1,190 € zzgl. MwSt. Kora Doorduyn-van der Stoep https://www.forum-institut.de/seminar/24052451-variations-in-europe/referenten/24/24_05/24052451-online-course-pharma-variations-in-europe_doorduyn-van-der-stoep-kora.jpg Variations in Europe

LAST CALL! - CANCELLATION DEADLINE: 29.04.2024 - Variation regulation, classification guideline, eSubmission, variation management: All processes explained in this online course. Save your place in our virtual zoom seminar room! The training course will be entirely held in English.

Topics
  • Classification and submission
  • Type IA Notification, Type IB and II Variations
  • Grouping and worksharing
  • Variation management
  • Quality-related variations: Changes in the production process, analytics, formulation and packaging


Who should attend
This practical seminar is aimed at anyone involved in planning, creating or submitting variations.
Employees in the following departments will particularly benefit from the seminar:
  • regulatory affairs;
  • quality assurance; and
  • production
Aims and objectives
This training will bring you the latest information in the planning, classification and submission of variations.

Day 1 addresses regulatory requirements in detail, particularly guidance documents, variation classification, use of the variation (e-)application form and organisation of grouping and worksharing.

Day 2 addresses the classification and handling of quality-related changes. Case studies on how to work with the classification guideline and the Q&A paper will reinforce your knowledge.

Your benefit

An extract from last year's participant feedback:

  • "I gained a very good insight into the topic "variations", thanks."
  • "Comprehensive overview, very helpful."
  • "Good to have different perspectives combined."

Online Course Variations in Europe

Variations in Europe

LAST CALL! - CANCELLATION DEADLINE: 29.04.2024 -

Benefits
  • Days may be booked seperately
  • Pose your individual questions in advance
  • Optional e-Learning bookable
  • Experts with local know-how
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 24052451

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

15-16/05/2024

15-16/05/2024

Zeitraum

Day I: 09:00 am - 5:00 pm - seminar
Day II: 09:00 am - 5:00 pm - seminar
You may dial in 30 minutes before the training starts

Day I: 09:00 am - 5:00 pm - seminar
Day II: 09:00 am - 5:00 pm - seminar
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

LAST CALL! - CANCELLATION DEADLINE: 29.04.2024 - Variation regulation, classification guideline, eSubmission, variation management: All processes explained in this online course. Save your place in our virtual zoom seminar room! The training course will be entirely held in English.

Topics

  • Classification and submission
  • Type IA Notification, Type IB and II Variations
  • Grouping and worksharing
  • Variation management
  • Quality-related variations: Changes in the production process, analytics, formulation and packaging


Who should attend
This practical seminar is aimed at anyone involved in planning, creating or submitting variations.
Employees in the following departments will particularly benefit from the seminar:
  • regulatory affairs;
  • quality assurance; and
  • production

Aims and objectives

This training will bring you the latest information in the planning, classification and submission of variations.

Day 1 addresses regulatory requirements in detail, particularly guidance documents, variation classification, use of the variation (e-)application form and organisation of grouping and worksharing.

Day 2 addresses the classification and handling of quality-related changes. Case studies on how to work with the classification guideline and the Q&A paper will reinforce your knowledge.

Your benefit

An extract from last year's participant feedback:

  • "I gained a very good insight into the topic "variations", thanks."
  • "Comprehensive overview, very helpful."
  • "Good to have different perspectives combined."

Detailed programme

Day I: 09:00 am - 5:00 pm - seminar
Day II: 09:00 am - 5:00 pm - seminar
You may dial in 30 minutes before the training starts

Welcome and introduction


Lidia Cánovas

Basics, fundamentals & classification
  • Variation regulation, classification guideline
  • Changes according to the variation regulation vs purely national changes
  • PACMP

Lidia Cánovas

Type IA-notification
  • Type IA-changes according to the classification guideline
  • Annual report
  • Immediate notification (Type IAIN)

Coffee break


Kora Doorduyn-van der Stoep

Type IB-variations
  • Type IB-changes according to the classification guideline
  • Timelines and processing
  • Type IB by default

Lidia Cánovas

Type II-variations
  • Processing of type II variations
  • Timelines, submission and validation

Lunch break


Kora Doorduyn-van der Stoep

Grouping and worksharing
  • Grouping of type IA notifications
  • Grouping of extensions and other
  • Grouping of different types of variations
  • Practical examples
  • Efficient variation management

Lidia Cánovas

Variation submission
  • E-only, consequences for MA dossier
  • Variation (e)-application form
  • CESP submission
  • Technical requirements

Coffee break


Lidia Cánovas

Special notification of change
  • Safety related changes and urgent safety restrictions
  • Line Extensions; "unforeseen" variations

André Mota

Variation management
  • Strategic planning and deadlines

End of seminar day I


André Mota

Changes in the production process
  • Notification or variation
  • Batch size change
  • Change in the manufacturing flow
  • Tech transfer/site transfer?

Coffee break


Dr. Regina Heckenberger

Changes in the formulation
  • API and excipient new suppliers
  • How to assess a change and build a submission plan
  • Challenges

Lunch break


Dr. Veronika Alt

Changes in the analytics - changes of:
  • Contract laboratories
  • Analytical methods
  • Acceptance criteria/specifications
  • Regulatory change control management

Coffee break


Dr. Regina Heckenberger

Packaging and production changes
  • Primary/secondary packaging (specification, testing)
  • Change of packaging sites
  • Labelling impact

All speakers

Practical examples and case studies

Q&As and outstanding questions


End of online seminar


Our Partner

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.



More information

LAST CALL! - CANCELLATION DEADLINE: 29.04.2024 -

Please note the stated cancellation period.
If you are interested at short notice, please contact me directly: b.wessels@forum-institut.de or 06221 - 500 652.

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.

Booking options

You have the option to organise your training according to your level of expertise and requirements. Each day can either be booked separately or in combination with the other day. Simply choose the topics you need.
If you are new to regulatory affairs, we also recommend our "Introduction to EU Marketing Authorisation" e-learning programme.

This distinguishes our events

of 5 stars of all ratings from 2023

of 5 stars on Trustpilot = good

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

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Testimonials


Good general overview.


Good organisation and interesting topics in a nice atmosphere.


From this seminar I expected to learn more about regulatory activities, in particular on quality changes, and know more about the experiences of other colleagues. I think that it met all my expectations.


I appreciated all the topics. The seminar was were structured, starting from an overview of all types of variations and line extensions, then focusing on quality changes with some case studies. I found all the advices on how to manage the documentation correctly.


Useful to deepen several aspects of regulatory activities.


2 Days with a full package on information required for regulatory managers working in/for Europe.