2023-01-30 2023-01-30 , online online, 1,150 € plus tax Dr. Edelgard Rehak https://www.forum-institut.com/seminar/23042454-regulatory-and-gmp-compliance-in-eastern-europe/referenten/23/23_04/23042454-online-training-regulatory-and-gmp-compliance-in-non-eaeu_rehak-edelgard.jpg Regulatory and GMP compliance in Eastern Europe

This online training provides you with in-depth knowledge on marketing authorisation, CMC and GMP requirements in (Non-)EAEU countries.

Topics
  • EAEU pharmaceutical market and Non-EAEU markets: 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 (Non-)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 (Non-)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

  • Knowledge of regulatory affairs procedures and of the Module 3 requirements
  • Proficiency in compiling the necessary marketing authorisation documents
  • Knowledge of the change management procedures
  • Understanding of the challenges of GMP inspections by local authorities

Online training - Regulatory and GMP compliance in (Non-)EAEU

Regulatory and GMP compliance
in Eastern Europe

- Online Training -

Benefits
  • First-hand information
  • Experts with local know-how
  • Submit your questions prior to the training
  • Inform us about your most relevant countries
  • We are following the IMI quality criteria

Webcode 23042454

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

26-27/04/2023

26-27/04/2023

Period

Each day from 09:00 am - 4:00 pm - o...

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

online

online

Fee
Your contact

Dr. Birgit Wessels
Conference Manager

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

Details

This online training provides you with in-depth knowledge on marketing authorisation, CMC and GMP requirements in (Non-)EAEU countries.

Topics
  • EAEU pharmaceutical market and Non-EAEU markets: 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 (Non-)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 (Non-)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

  • Knowledge of regulatory affairs procedures and of the Module 3 requirements
  • Proficiency in compiling the necessary marketing authorisation documents
  • Knowledge of the change management procedures
  • Understanding of the challenges of GMP inspections by local authorities

Detailed programme

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

09:00 Welcome, expectations, introduction


09:15

Dr Edegard Rehak

Regulatory Status quo of the EAEU Pharmaceutical market and Non-EAEU markets
  • Agreement on common market: GxP principles
  • Rules of registration and expertise of medicinal drugs (EEEC 78 and N36)
  • Content of CTD registration dossier

10:45 Coffee break


11:00

Dr Edegard Rehak

New registration of medicinal drugs in the EAEU
  • Mutual Recognition Procedure, Decentralised Procedure
  • GCP and GMP as precondition for NDAs
  • SmPC/PIL/Labelling/Readability test

12:15 Lunch break


13:15

Dr Edegard Rehak

Upgrade procedure
  • Legal framework
  • Process & timelines
  • Practical experiences & examples

14:30 Coffee break


14:45

Dr Edegard Rehak

Variations in the EAEU: Current status and expected changes
  • Legal framework
  • Practical experiences & examples

15:45 Q&As


16:00 End of seminar day I


09:00 Welcome and open questions


09:15

Dr Edegard Rehak

CMC documents for marketing authorisation
  • ND national: ND EAEU
  • Requirements of Module 3

10:00 Coffee break


10:15

Michael Faust

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

11:15

Michael Faust

Practical examples
  • Compiling an EAEU submission

11:45 Lunch break


12:45

Dr Edelgar Rehak and Michael Faust

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

14:15 Coffee break


14:30

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

15:30 Summary and outstanding questions


16:00 End of online seminar


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.

  • You will find brief instructions on how to use Zoom, your course documentation, the access link and a meeting ID in your personal customer account.
  • Use a headset, loudspeakers or the telephone for audio.
  • Listen to the speaker and follow the presentation.
  • 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

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

e-Learning: Marketing Authorisation Outside the ICH Region

Do you need regulatory affairs expertise for submissions outside the ICH region? Then this e-learning programme is the fast track to becoming knowledgeable in this field, providing you with the fundamentals of regulatory affairs outside the EU, the US and Japan.

The e-learning programme will familiarise you with the regulatory affairs principles outside the ICH region and show you how to categorise the various regions in terms of regulatory requirements.

Subsequently, you will be able to assess the data necessary to apply for a marketing authorisation and be knowledgeable about the CPP requirements. In other words, you will have the tools to develop a submission strategy.

E-learning principles

The e-learning programme 'Marketing Authorisation Outside the ICH Region' comprises three didactic modules that include videos in which the expert Karl-Heinz Loebel shares his expertise with you. You can also download and print the corresponding presentation documents.

Each module comprises additional documents (links, guideline texts, etc.) as well as interactive exercises and questions, which help you practise and apply your newly gained knowledge.

Once you have completed the three modules and passed a final multiple-choice test, you will be awarded a certificate, which you can print out directly. The e-learning programme should be completed within three months. Try our e-learning programme for free and familiarise yourself with our learning environment.

How to book the e-learning programme in addition to the seminar

Please register for the seminar "Regulatory Affairs, CMC & GMP in Russia & EAEU" by clicking '"Register" or "Buchen". You will receive a €100 discount if you also book the e-learning programme (you will be billed €290 + local VAT rather than €390 + local VAT).

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Testimonials

Comments of the participants (February 2017)
Both speaker were honest with their opinion 5


I like most about this event: the interactive part


Free discussion

Comments of the participants (August 2017)
Possibility to get answers to specific questions.


Excellent inside view of what is happening in the main CIS countries.


Useful information of the different countries.