Course description
Gaining Marketing Authorisations in CIS for Pharmaceuticals and Biotech - 2-day course
The growing commercial importance of CIS markets has a direct impact on the size of the pharmaceutical industry in the region, with Russia accounting for a large proportion of the entire Central and Eastern Europe pharmaceutical market. It is essential that pharmaceutical companies keep up-to-date with the latest regulatory developments to ensure their place on the CIS market.
This essential two-day training course covers the latest updates on the regulatory processes for gaining marketing authorisation in CIS countries including registration procedures, timelines and fees, looking at key considerations for labelling requirements, regulatory maintenance and pharmacovigilance.
PTI's course integrates theory with practical case studies, allowing participants to develop the knowledge needed to successfully navigate the pharmaceutical market in Russia and other key CIS countries.
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Suitability - Who should attend?
This course is suitable for professionals working in, have affiliate offices in or are thinking of expanding to the Russia/CIS region. The programme is aimed at 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
Training Course Content
This training course is designed to cover the following learning points:
- An overview of regulatory requirements for each CIS country
- How to develop successful regulatory strategies for the entire region
- What the authorities expect to ensure first-time approval of your application
- A comprehensive understanding of clinical trial requirements in Russia
- Which application types will require local clinical data
- Building strategies for working with affiliates and regulatory outsourcing in the CIS region
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5
Reviews
Average rating 5
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.
Expenses
The cost of this training course is £1400 + VAT per participant, which covers tuition and course materials.
In-house Training
PTI - Pharmaceutical Training International can also deliver this course as in-house training for your company. You can reduce costs, enhance accessibility to training resources and better address your company’s own business goals with a tailored PTI training package.
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.