PTI is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Informa

Welcome. If you're a registered user, please log-in. If not, please sign-up.

VIEW AGENDA | DOWNLOAD AGENDA

Gaining Marketing Authorisations in CIS for Pharmaceuticals and Biotech

2020 Dates TBC

Le Palais Art Hotel Prague

Agenda

An essential overview of regulatory requirements to ensure successful strategies for gaining market access in the CIS

View Agenda Register

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.

Gaining Marketing Authorisations in CIS for Pharmaceuticals and Biotech

2020 Dates TBC

Le Palais Art Hotel Prague

An essential overview of regulatory requirements to ensure successful strategies for gaining market access in the CIS

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

you may also be interested in...

An essential overview of regulatory requirements to ensure successful strategies for gaining market access in the CIS

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

you may also be interested in...

Regulatory Affairs Strategies

PTI Course Calendar

Module 3 of the Global CTD

Fundamentals of Clinical Trials Regulations

Preparing the Quality Module of the CTD

Mastering Regulatory and Development Strategies for Generics

US-FDA Drug Submission Procedures

Regulatory Affairs for Clinical Trials

Project Management for Regulatory Affairs Professionals

Pharmaceutical Regulatory Affairs in China

eCTD Submissions

Introduction to Regulatory Affairs in the MENA Region

Regulatory Affairs in Latin America

EU & US Requirements for Pharmaceutical Labelling & Package Leaflets

Challenges in Drug/Device Combination Products

Advanced European Regulatory Affairs

Filing Variations

Introduction to EU Regulatory Affairs

Fundamentals of EU Regulatory Affairs

Regulatory Information Management and IDMP Training