Regulatory Affairs/CMC and GMP Inspections in Russia and the EAEU
Online seminar on Regulatory Affairs and GMP Compliance in Russia, Belarus, Kazakhstan and Ukraine
- Regulatory framework in Russia, Kazakhstan, Belarus, Ukraine and the EAEU
- Marketing authorisation with a focus on CMC-document requirements
- Variations and change management
- The new certification process in Russia
- GMP inspections in Russia, Kazakhstan and Belarus
This distinguishes our event
Aims and objectivesThis online seminar provides you with in-depth 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 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 in-depth knowledge 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, and you will know what Russian GMP inspectors expect.
- 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.
All registered participants are welcome to send their questions to the speakers prior to the seminar.
Day 2: 09:00-17:00
Day 3: 09:00-17:00
- Overview of the CIS markets
- Comparative overview of the current regulatory development in the CIS region
- Degree of regulatory harmonisation with ICH, WHO, PIC/S and EU regulations
- Dossier requirements and labelling
- Fast-track procedures
- Processes and timelines
15:00 Coffee break
- Regional registration process, recognition and harmonisation of licences and maintenance applications
- Scope, authorities, timelines and dossier requirements/GMP
- MRP, DCP and the cessation of national procedures
- Dossier upgrade procedure
17:00 End of day one
- Pharmaceutical Market in Russia
- Registration process
- CTD dossier and the normative document
- Labelling documents & serilisation
- Interchangeability and content of PIL/SmPC
- Latest changes in FL 61
10:30 Coffee break
- Module 3 and the normative document - the challenges
- Relevance of Russian pharmacopoeia
- Certificate of analysis
- Regulatory impact of site transfer
- Localisation of production
15:30 Coffee break
- Release and shelf-life specifications
- Regulatory and quality requirements
- Certificate of Analysis
17:00 End of day two
- Preparation; inspectors' expectations
- Recognition of GMP, PIC and CIS countries
- GMP inspection peculiarities in Russia: agenda, cultural differences, language ...
10:30 Coffee break
- Change management: Theory is not quite the same as practice
- Handling regulatory non-compliance in GMP inspections
15:00 Coffee break
- Experiences of GMP inspections of production sites outside Russia
17:00 Seminar end
Dr Rehak is an expert on registration in Russia and Central and Eastern Europe. From 2011 to 2014, she worked as Regulatory Director at Sanofi and Medical Director at Zentiva, based in Moscow, and prior to that, from 2006 to 2009, as Head Regulatory and QA for Novartis, based in Kiev, Ukraine. She has a broad range of experience in bioequivalence and toxicological trials in Russia. Until 2006, she held several positions in product development (Gx and biosimilars) and clinical research at Sandoz/HEXAL, Germany.
Nähere Informationen finden Sie hier.
Head of Product Market Authorization and Quality Assurance, PhD in Pharmaceutical Chemistry. 20 years in regulatory area in total: for 6 years - Tutor of Pharmaceutical Chemistry at Pharmaceutical State University (Pyatigorsk, Russia), 9 years of experience in Drug Product development for Russian manufacturers and 6 years - in local batch release quality control; 11 years in Big Pharma RA departments.
- 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 GMP inspections and how to deal with them
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.
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.
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).
Both speaker were honest with their opinion 5
I like most about this event: the interactive part
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.
Many examples, very friendly and interactive.
Examples out of everyday experience
Feedback and information based on pracitcal experience of the speakers
This training is so well explained, complete and well recommende with examples that I suggest to everybody.
Very useful, great expertise of speakers
OM Pharma SA
Nice and qualified speakers
The discussions and single experiences
Many new information regarding the CIS
Sufficient examples, possibility to ask many questions as we wanted
Very interactive, interesting
Very organized, very informative, questions were answered
Very informative, very good backround of speakers
Klarheit und praxisnähe
The many practical examples and the comprehensive answers to individual questions from participants
After having attended this online seminar, you will be aware of the key components of RI and its practical use in your role as a regulatory professional.
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