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Gaining Marketing Authorisations in CIS for Pharmaceuticals and Biotech

2020 Dates TBC

Le Palais Art Hotel Prague

The pharmaceutical and biotech markets within the Commonwealth of Independent (CIS) states are complex and unique to the region. The regulatory landscape in countries such as Russia and Ukraine is constantly changing making it difficult for organisations to remain compliant.

Using a combination of theory and practical case studies you will develop the knowledge needed to successfully navigate the pharmaceutical market in Russia and other key CIS countries. This essential 2-day course will provide you with the latest updates on the regulatory processes for gaining marketing authorisation in CIS countries including registration procedures, timelines and fees plus key considerations for labelling requirements, regulatory maintenance and pharmacovigilance.

  • Explore the commercial significance of CIS markets
  • Evaluate the degree of regulatory harmonisation with ICH and EU requirements
  • Gain a full understanding of the regulatory landscape in Russia including local clinical trial requirements
  • Understand registration procedures, timelines, fees and pharmacovigilance requirements for all key CIS countries including Ukraine, Kazakhstan and Belarus

Dr Edelgard Rehak

Edelgard Rehak has more than 20 years’ experience in the development and registration of medicinal drug products and medical devices. Her speciality areas are Russia and the CIS.  

From 2012 to 2015, Edelgard worked as Medical Director for Zentiva, a Sanofi company, and later as Head of Registrations for Sanofi, based in Moscow. Previously, she worked as the Head of Registrations for the CIS for Novartis in Kiev. In 2010, Edelgard established her own consultancy and now delivers consultancy and training for clients wishing to enter the Russian and/or CIS markets.

This course is suitable for professionals working in, have affiliate offices in or are thinking of expanding to the Russia/CIS region. In particular, the course will benefit Heads of Department, Directors, Managers, Consultants, Project Leaders and Project Officers working in the areas of:

  • Regulatory affairs
  • Regulatory operations
  • International regulatory affairs
  • Global regulatory operations
  • Dossier management
  • Information management

It was a great course; I picked up a lot of new information and historical background that helped explain some of the differences and concepts.

 Regulatory Director, LangAllan CMC Regulatory Solutions Ltd

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