An essential overview of regulatory requirements to ensure successful strategies for gaining market access in the CIS
Course Overview
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 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 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.
Live Online Academies
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses.
Students will learn through:
- Live interactive sessions
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
- Revisiting recorded sessions with unlimited access for 30 days
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact lifesciences-training@informa.com.
What will you learn?
Introduction to CIS markets
Explore the commercial significance of CIS markets
Harmonisation
Evaluate the degree of regulatory harmonisation with ICH and EU requirements
Regulatory landscape
Gain a full understanding of the regulatory landscape in Russia including local clinical trial requirements
Procedures for registration
Understand registration procedures, timelines, fees and pharmacovigilance requirements for all key CIS countries including Ukraine, Kazakhstan and Belarus
Who is this course for?
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
CPD Certified
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.
Delegates of our live online academies said...
94%
would attend another live online academy
97%
found the course beneficial to their day to day role
97%
would recommend the course to others