2021-12-27 2022-04-28 , Online Online, 1.090,- € zzgl. MwSt. Kora Doorduyn-van der Stoep https://www.forum-institut.de/seminar/22042451-variations-in-europe/referenten/22/22_04/22042451-online-course-variations-in-europe_doorduyn-van-der-stoep-kora.jpg Variations in Europe

Variation regulation, classification guideline, eSubmission, variation management: All processes explained in this online course. Save your place in our virtual zoom seminar room!

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
Aims and objectives
This seminar will bring you the latest 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.
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

Online Course Variations in Europe

Variations in Europe

- Online training -

Benefits
  • Days may be booked seperately
  • Pose your individual questions in advance
  • Optional e-Learning bookable
  • Experts with local know-how
  • We are following the IMI quality criteria

Webcode 22042451

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Referenten


Alles auf einen Blick

Termin

27. - 28.04.2022

27. - 28.04.2022

Zeitraum

Day 1: 09:00 - 17:00 seminarDay 2: 0...

Day 1: 09:00 - 17:00 seminar
Day 2: 09:00-17:00 seminar
Veranstaltungsort

Online

Online

Gebühr
Ihr Ansprechpartner

Dr. Birgit Wessels
Conference Manager

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

Details

Variation regulation, classification guideline, eSubmission, variation management: All processes explained in this online course. Save your place in our virtual zoom seminar room!

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
Aims and objectives

This seminar will bring you the latest 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.

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

Detailed programme

Day 1: 09:00 - 17:00 seminar
Day 2: 09:00-17:00 seminar

09:00 Welcome and introduction


09:15

Lidia Cánovas

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

10:00

Lidia Cánovas

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

10:30 Coffee break


10:45

Kora Doorduyn-van der Stoep

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

11:15

Lidia Cánovas

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

12:00 Lunch


13:00

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

14:00

Lidia Cánovas

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

15:15 Coffee break


15:30

Lidia Cánovas

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

16:00

André Mota

Variation Management
  • Strategic planning and deadlines

17:00 Day 1 ends


09:00

André Mota

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

10:30 Coffee break


10:45

Dr. Regina Heckenberger

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

12:15 Lunch


13:15

Dr. Veronika Alt

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

14:30 Coffee break


14:45

Dr. Regina Heckenberger

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

16:00

All speakers

Practical examples and case studies

16:45 Q&As and outstanding questions


17:00 Seminar ends


Course days & topics

Day 1: Variations: The basics

27 April 2022

Mittwoch, 27.04. - 09:00 bis 17:00 Uhr
Kora Doorduyn-van der Stoep, Lidia Cánovas, André Mota
Day 2: Quality related Variations

28 April 2022

Donnerstag, 28.04. - 09:00 bis 17:00 Uhr
Dr Veronika Alt, Dr Regina Heckenberger, André Mota

More information

How does an online seminar work?

Our online training courses are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live.

1. You will receive brief instructions on how to use Zoom beforehand.
2. You will find all necessary informations in your customer portal
3. Use a headset, loudspeakers or the telephone for audio.
4. Listen to the speaker and follow the presentation.
5. Feel free to switch from silent to audio mode by yourself any time to ask your questions.

The benefits of an online seminar

  • Attend the training in all comfort, from wherever you like
  • There are no travel and accommodation costs
  • Ask questions live whenever you desire

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

Overall impression: 100% of the participants’ feedback was very good or good. (October 2020)

Practical Benefit: 100% of the participants’ feedback was very good or good. (October 2020)

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Go forward

DEMO-Account e-Learning

Try out our e-Learning programmes free of charge and without any obligation.

Details
DEMO-Account e-Learning
List of abbreviations

Many abbreviations are used in all regulatory areas. Download the list of the most important ones.

Details
Abbreviations, Glossary
Quality guaranteed!

Your feedback produced as result of 1.8 in 2021. Thank you!

Details
More on our quality criteria

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.