2024-04-12 2024-04-12 , online online, 1,890 € zzgl. MwSt. Dr. Edelgard Rehak https://www.forum-institut.de/seminar/24042454-regulatory-affairs-and-gmp-compliance-in-eastern-europe/referenten/24/24_04/24042454-online-training-regulatory-and-gmp-compliance-in-eaeu_rehak-edelgard.jpg Regulatory Affairs and GMP compliance in Eastern Europe

Get know-how on the LATEST CHANGES (EECC 114) in the EAEU Upgrade Procedure - This online training provides you with in-depth knowledge on Regulatory Affairs, CMC and GMP requirements in EAEU countries.

Topics
  • EAEU pharmaceutical market:
  • Regulatory Status quo
  • Registration of new drugs in the EAEU
  • Variations in the EAEU
  • CMC documents for marketing authorisation
  • and many more topics


Who should attend
This seminar is primarily intended for those
  • dealing with regulatory affairs/CMC in EAEU countries; and
  • preparing for and/or attending GMP inspections in these countries.

Regulatory affairs, CMC, quality and business development staff will particularly benefit from this seminar.
Aims and objectives
This online training provides you with indepth knowledge on the current challenges when applying for a new marketing authorisation, as well as the maintenance activities and challenges of GMP inspections in EAEU countries.

After having attended the seminar, you will be aware of the dossier requirements for the different regions. You will be able to prepare the CTD dossier, especially Module 3. Moreover, you will be familiar with the change management requirements to achieve regulatory and GMP compliance.
Our experts will share theoretical and practical knowledge on how to compile an EAEU electronic submission.
Finally you will be able to prepare for and pass GMP inspections by local authorities.
Your benefit

During the course you will receive answers to the following questions/issues:

  • Latest changes in EAEU legislation: variations and upgrade procedure - What can be submitted simultanously? Latest NEWS
  • How to harmonise SmPC & PIL in EAEU upgrade procedure?
  • Simplifications in EAEU upgrade procedure
  • Is 2025 the final deadline for upgrade procedure in EAEU?
  • and more

Online training - Regulatory and GMP compliance in EAEU

Regulatory and GMP compliance
in Eastern Europe

- Online Training -

Benefits
  • Latest changes (EECC 114) in EAEU Upgrade Procedure
  • Experts with local know-how
  • Regulatory/CMC and GMP know-how
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 24042454

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

15-16/04/2024

15-16/04/2024

Zeitraum

Each day from 09:00 am - 4:00 pm - online seminar
You may dial in 30 minutes before the training starts

Each day from 09:00 am - 4:00 pm - online 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

Get know-how on the LATEST CHANGES (EECC 114) in the EAEU Upgrade Procedure - This online training provides you with in-depth knowledge on Regulatory Affairs, CMC and GMP requirements in EAEU countries.

Topics

  • EAEU pharmaceutical market:
  • Regulatory Status quo
  • Registration of new drugs in the EAEU
  • Variations in the EAEU
  • CMC documents for marketing authorisation
  • and many more topics


Who should attend
This seminar is primarily intended for those
  • dealing with regulatory affairs/CMC in EAEU countries; and
  • preparing for and/or attending GMP inspections in these countries.

Regulatory affairs, CMC, quality and business development staff will particularly benefit from this seminar.

Aims and objectives

This online training provides you with indepth knowledge on the current challenges when applying for a new marketing authorisation, as well as the maintenance activities and challenges of GMP inspections in EAEU countries.

After having attended the seminar, you will be aware of the dossier requirements for the different regions. You will be able to prepare the CTD dossier, especially Module 3. Moreover, you will be familiar with the change management requirements to achieve regulatory and GMP compliance.
Our experts will share theoretical and practical knowledge on how to compile an EAEU electronic submission.
Finally you will be able to prepare for and pass GMP inspections by local authorities.

Your benefit

During the course you will receive answers to the following questions/issues:

  • Latest changes in EAEU legislation: variations and upgrade procedure - What can be submitted simultanously? Latest NEWS
  • How to harmonise SmPC & PIL in EAEU upgrade procedure?
  • Simplifications in EAEU upgrade procedure
  • Is 2025 the final deadline for upgrade procedure in EAEU?
  • and more

Detailed programme

Each day from 09:00 am - 4:00 pm - online seminar
You may dial in 30 minutes before the training starts

Welcome, expectations, introduction


Dr Edegard Rehak

Regulatory status quo of the EAEU pharmaceutical market
  • Rules of registration and expertise of medicinal drugs (EECC 78 as amended)
  • Recent changes (EECC 114, effective May 2024)
  • National registrations possible?

Coffee break


Dr Edegard Rehak

New drug registrations in the EAEU
  • Mutual Recognition Procedure, Decentralised Procedure
  • GCP and GMP as preconditions for NDAs
  • SmPC/PIL/Labelling/Readability test
  • Module 1 of registration dossier

Lunch break


Dr Edegard Rehak

EAEU upgrade procedure
  • Legal framework
  • Process and timelines
  • Content of dossier

Coffee break


Dr Edegard Rehak

Variations in the EAEU
  • What is the best submission strategy?
  • Current legal framework and expected changes
  • Practical experiences and examples

Q&As


End of seminar day I


Welcome and open questions


Dr Edegard Rehak

CMC documents for marketing authorisation
  • Requirements of Module 3
  • EAEU pharmacopoeia and ND writing

Coffee break


Michael Faust

eSubmission challenges
  • Special EAEU requirements: Comparison with EU requirements
  • XML Backbone
  • Document requirements

Michael Faust

Practical examples
  • Compiling an EAEU submission

Lunch break


Dr Edelgar Rehak and Michael Faust

Discussion round: Current situation in Russia
  • Role of Russia in the EAEU

Coffee break


Dr Edelgar Rehak

GMP inspections by local EAEU authorities
  • The end of the national GMP certification in EAEU
  • Legal framework
  • Timelines
  • GMP requirements in Non-EAEU countries

Summary and outstanding questions


End of online seminar


More information

LATEST CHANGES (EECC #114) in EAEU Upgrade Procedure

You are more than welcome to provide us with your individual questions on the latest developments prior to the scheduled seminar date.

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.

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Testimonials


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Examples out of everyday experience

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PHARMA CONSULTING


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OM Pharma SA


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