2021-12-11 2022-10-13 , Online Online, 1.090,- € zzgl. MwSt. Dr. Edelgard Rehak https://www.forum-institut.de/seminar/22102460-regulatory-affairs-cmc-and-gmp-in-russia/referenten/22/22_10/22102460-online-training-regulatory-affairs,-cmc-gmp-in-russia-eaeu_rehak-edelgard.jpg Regulatory Affairs, CMC and GMP in Russia

This online training provides you with in-depth knowledge on marketing authorisation, CMC and GMP requirements in Russia, Belarus, Kazakhstan and Ukraine. These are your booking options: Day I+II (basic training course): € 1.690,00 (+ German VAT), Day III (focus GMP, course may be booked separately): € 1.090 (+ German VAT), Day I-III: € 2.480,00 (+ German VAT)

Topics
  • Regulatory framework in Russia, Ukraine, CIS and EAEU countries
  • Marketing authorisation with a focus on CMC-document requirements
  • Variations and maintenance
  • GMP inspections in Russia and EAEU
  • GMP remote inspections: Experiences and recommendations
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, including recommendations for remote inspections.

After having attended days one and two, you will be aware of the dossier requirements for Russia, Kazakhstan, Belarus and Ukraine, particularly with regard to CMC. You will also be able to prepare the CTD dossier, especially Module 3 and the normative document for Russia. Moreover, you will be familiar with the change management requirements to achieve regulatory and GMP compliance.

Day three will provide you with know-how on the current requirements for GMP inspections by local authorities in Russia, Kazakhstan and Belarus. You will be able to prepare for and pass these GMP inspections, even if these should be carried out remote.
Who should attend

This seminar is primarily intended for those

  • dealing with regulatory affairs/CMC in EAEU countries (Russia, Kazakhstan and Belarus in particular) and/or Ukraine; 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.

Online training - Regulatory Affairs, CMC & GMP in Russia & EAEU

Regulatory Affairs, CMC and GMP in Russia

- Online Training -

Benefits
  • First-hand information
  • Experts with local know-how
  • Submit your questions prior to the training
  • Day I+II basic training, day III bookable separately
  • We are following the IMI quality criteria

Webcode 22102460

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

11. - 13.10.2022

11. - 13.10.2022

Zeitraum

Day 1+2: 09:00 am - 4:00 pmDay 3: 09...

Day 1+2: 09:00 am - 4:00 pm
Day 3: 09:00 am - 4:00 pm
Veranstaltungsort

Online

Online

Downloads
Gebühr
Ihr Ansprechpartner

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 Russia, Belarus, Kazakhstan and Ukraine. These are your booking options: Day I+II (basic training course): € 1.690,00 (+ German VAT), Day III (focus GMP, course may be booked separately): € 1.090 (+ German VAT), Day I-III: € 2.480,00 (+ German VAT)

Topics
  • Regulatory framework in Russia, Ukraine, CIS and EAEU countries
  • Marketing authorisation with a focus on CMC-document requirements
  • Variations and maintenance
  • GMP inspections in Russia and EAEU
  • GMP remote inspections: Experiences and recommendations
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, including recommendations for remote inspections.

After having attended days one and two, you will be aware of the dossier requirements for Russia, Kazakhstan, Belarus and Ukraine, particularly with regard to CMC. You will also be able to prepare the CTD dossier, especially Module 3 and the normative document for Russia. Moreover, you will be familiar with the change management requirements to achieve regulatory and GMP compliance.

Day three will provide you with know-how on the current requirements for GMP inspections by local authorities in Russia, Kazakhstan and Belarus. You will be able to prepare for and pass these GMP inspections, even if these should be carried out remote.

Who should attend

This seminar is primarily intended for those

  • dealing with regulatory affairs/CMC in EAEU countries (Russia, Kazakhstan and Belarus in particular) and/or Ukraine; 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.

Detailed programme

Day 1+2: 09:00 am - 4:00 pm
Day 3: 09:00 am - 4:00 pm

09:00 Reception and introduction round


09:15

Edelgard Rehak

Registration of medicines in RU, KZ, BY, UA and UZ
  • Comparative overview of current regulatory developments in the CIS region
  • Degree of regulatory harmonisation with ICH, WHO, PIC/S and EU regulations
  • New submissions
  • Maintenance of registrations

10:45 Coffee break


11:00

Edelgard Rehak

Basic principles of registrations (EAEU)
  • Legal framework
  • Authorities

12:15 Lunch break


13:00

Galina Senchukova

Russia - A regulatory overview I
  • Authorities, registration process
  • Interchangeability, PIL/SmPC
  • Maintenance of registrations

13:45 Coffee break


14:00

Galina Senchukova

Russia - A regulatory overview II
  • CTD dossier and electronic submission
  • Serialisation
  • Latest changes in FL 61

16:00 End of training day 1


09:00

Galina Senchukova

CMC documents for marketing authorisation in detail
  • Module 3 and the normative document
  • Certificate of analysis
  • Relevance of Russian Pharmacopoeia
  • Regulatory impact of site transfer
  • Localisation of production

10:30 Coffee break


10:45 Continuation: CMC documents for marketing authorisation in detail


11:30

Galina Senchukova

Official batch release procedure
  • Regulatory and quality requirements
    • For "pharma" products
    • For immunobiological products

12:00 Lunch break


13:00

Edelgard Rehak

Regulatory framework in the Eurasian Custom Union (EAEU) between RU, KZ, BY, AM, KG - overview
  • First experiences with new submissions (MRP/DCP)
  • Dossier upgrade procedure
  • Status of harmonisation (Phamacopeia, GMP)
  • Variations and maintenance
  • e-CTD practical advice

16:00 End of training day 2


09:00 Reception and introduction round


09:15

Galina Senchukova

GMP inspections by authorities in Russia, Kazakhstan, Belarus and EAEU
  • Regulations and costs
  • Recognition of GMP, PIC and CIS countries
  • Site preparation

10:45 Coffee break


11:00

Galina Senchukova

Challenges of GMP inspections by Russian authorities
  • GMP inspection peculiarities in Russia: agenda, cultural differences, language, etc.
  • Change Management
  • Handling regulatory non-compliance in GMP inspections
  • Handling rejections of GMP inspections: industry experiences

12:15 Lunch break


13:00 Continuation: Challenges of GMP inspections by Russian authorities


13:45 Coffee break


14:00

Edelgard Rehak

Remote GMP inspections - experiences and recommendation

15:30 Concluding discussion


16:00 End of online training


Learning outcomes

Booking options

You have the option to organise your training according to your level of expertise and requirements. Day I+II can either be booked separately or in combination with Day III.

Day I + Day II: € 1.690,00 (+ German VAT)
Day I + Day II + Day III: € 2.480,00 (+ German VAT)
Day III (may be booked separately): € 1.090,00 €

Your learning outcomes

  • Knowledge of regulatory affairs procedures in Russia, Belarus, Kazakhstan and Ukraine
  • Detailed knowledge of the Module 3 requirements in Russia
  • Proficiency in compiling the necessary marketing authorisation documents
  • Knowledge of the change management procedure in Russia
  • Knowledge of GMP inspection peculiarities in Russia
  • Understanding of the challenges of (remote) GMP inspections and how to deal with them

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).

This distinguishes our events

Overall score of all evaluations in 2020

Five stars on Trustpilot = Excellent

Recommendations

Pharmacovigilance in Europe - Introductory e-Learning

Do you need to be well versed in European pharmacovigilance for your daily work? Then we recommend this e-Learning. You ...

31.12.2021, Online
Details

e-Learning: EU Variation System & Procedures

This e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of var...

31.12.2021, Online
Details

eCTD preparation and submission

This online training programme consisting of three recorded webcasts will train you how to develop documents, compile th...

31.12.2021, Online
Details

e-Learning: Marketing Authorisation Outside the ICH Region

This e-learning will familiarise you with the regulatory affairs principles outside the ICH region and show you how to c...

31.12.2021, Online
Details

e-Learning: Common Technical Document & eCTD

Do you need know how regarding CTD/eCTD & CMC? Then this e-learning programme is the fast track to becoming knowledgeabl...

31.12.2021, Online
Details

Go forward

Pharma FORUM Webcast International

International experts will inform you of the latest trends in global marketing authorisation and drug safety.

Details
Pharma Webcast Global RA & PV
e-Learning - Click and learn

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

Details
e-Learning
Quality guaranteed!

Your feedback produced as result of 1.7 in 2020. Thank you!

Details
More on our quality criteria

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.