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Informa

Gaining Marketing Authorisations in CIS for Pharmaceuticals and Biotech

6 - 7 December 2017

Radisson Blu Edwardian Grafton, London

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.

Using a combination of theory and practical case studies, the course will allow delegates to develop the knowledge needed to successfully navigate the pharmaceutical market in Russia and other key CIS countries.

  • 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

Anna Harrington-Morozova

Anna Harrington-Morozova is a regulatory, drug development and external relations professional with over 20 years’ experience gained in regulatory authority, academia and industry environments.

Anna’s senior positions in the global pharmaceutical and health care industry in Russia and the UK included Procter & Gamble, EISAI, GSK as well as global CROs and consultancies PAREXEL, ICON and PRA.

Anna currently acts as an Executive Director of RAPIEM (Regulatory Affairs Professionals for Innovations in Emerging Markets) and Scientific and Regulatory Director at Regem Consulting Ltd. 

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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