FORUM INSTITUT
FORUM · Institut für Management GmbH
Vangerowstraße 18
69115 Heidelberg
Email: service@forum-institut.de
Phone: +49 6221 500-500
Fax: +49 6221 500-505
Course Regulatory Affairs, CMC & GMP in Russia & EAEU
Marketing Authorisation
and GMP in Russia, Belarus,
Kazakhstan and Ukraine
2018-12-03 2019-06-05 NH Frankfurt Airport Mörfelder Str. 113 65451 Frankfurt nhfrankfurtairport@nh-hotels.com +49 6107 938-0 +49 6107 938-100

Regulatory Affairs/CMC and GMP Inspections in Russia and the EAEU

Regulatory Affairs and GMP Compliance in Russia, Belarus, Kazakhstan and Ukraine

This seminar provides you within-depth knowledge on marketing authorisation, CMC documents and GMP-requirements in Russia, Belarus, Kazakhstan and Ukraine.
Topics
  • National registration in Russia, Kazakhstan, Belarus and Ukraine
  • Marketing authorisation with a focus on CMC-document requirements
  • Regulatory and GMP compliance
  • GMP inspections in Russia, Kazakhstan and Belarus
  • Handling regulatory non-compliance in GMP inspections

This distinguishes our event

85%
Overall impression: 85 % of the participants' feedback was very good or good (May 2018)
85%
Course content: 85 % of the participants' feedback was very good or good (May 2018)
85%
Practical benefit: 85 % of the participants' feedback was very good or good (May 2018)

Aims and objectives

This 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 in Russia, Kazakhstan, Belarus and other EAEU countries. You will be able to prepare for and pass these GMP inspections, and you will know what Russian GMP inspectors expect.

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.

All registered participants are welcome to send their questions to the speakers prior to the seminar.
Your Speakers
Your speaker day 1
Dr. Edelgard Rehak
Dr Edelgard Rehak Consulting, GERMANY

Your speakers day 2+3: Dr Edelgard Rehak and
Galina Senchukova, PhD
CSL Behring Biotherapies, Moscow, RUSSIA


Go forward

Pharma Webcast Global RA & PV

Pharma FORUM Webcast International

We would like to invite you to join our live webcasts, where local regulatory affairs and vigilance experts will inform you every two months of the latest news and trends in global marketing authorisation and drug safety.

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e-Learning

e-Learning - Click and learn

The FORUM · Institut für Management GmbH provides flexible education and training with high-quality
e-Learning programmes for several topics.

You can access top expertise from anywhere.

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More on our quality criteria

Quality guaranteed!

IMI (Innovative Medicines Initiative) defined quality criteria for professional training and education. We follow these criteria and, as a signatory, we are an active partner in further developing and optimising the quality standards.

An aggregate evaluation of participants' feedback on all FORUM's healthcare training courses (evaluation period from 10.2017 - 09.2018 produced a result of 1.6 (based on a school grading system of 1-6).

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