Webinar: Affiliate Based Outsourcing for Regulatory Affairs
Affiliate based Outsourcing Model for Regulatory Affairs works as a replacement or an extension of the company’s internal and local RA resources. Many challenges come up from managing your RA activities as sometimes their processes are not harmonized across different countries, the resources are not cost-optimized or simply there isn’t enough of them.
Thus, the purpose of this webinar is to share practical tips and insights on the effective optimization of local regulatory affairs setup, management and relevant costs.
You will learn about:
- Advantages of ABO model with regards to Governance, Workload, Quality and Cost optimization.
- Practical Tips for project setup, management, oversight and methodology.
- Collaboration map between client and provider.
Expanding Your Geographical Reach?
Make use of our experience to expand across Europe. Explore your options in an informal chat with one of our experts.
Who Should Attend?
- Global and regional RA Managers
- Regulatory Strategy Managers
- RA Partnerships Operations Manager
- QA Managers supporting RA
- RA Healthcare Compliance Managers
Duration: 40 min.
Speakers:
- Head of Global Regulatory Affairs, Olga Bernardova;
- Head of Project Managers for Regulatory Affairs, Claudia Ghislieri.
Olga Bernardova, MSc
Head of Global Regulatory Affairs
Other content that might interest you:
Successful Medical Device Registration in EAEU: New Legislation (Part 1)
Webinar: Successful Medical Device Registration in EAEU: New Legislation (Part 1) The webinar discusses and explains the basic, essential, and theoretical matters of the EAEU system, outlines the new approach to the quality, safety, and efficacy assessments, and...
Saudi FDA’s New Pricing Guidelines and Impact on the Region
In a highly evolving regional pricing environment, Saudi Arabia (KSA) is no exception. The Saudi Food and Drug Authority (SFDA) has been periodically reviewing its pricing mechanisms and criteria so that the country becomes a regional reference for the prices of pharmaceutical products. What followed is a change in the pricing strategy by SFDA and a shift from price takers to price makers.
Webinar: Regulatory Strategy in the EAEU and Rest of CIS Countries
Regulatory strategy in EAEU and CIS regions differ from other regions as market access to these countries can be a real challenge due to various local regulations. However, it is only a matter of experience and adequate know-how. This webinar focuses on choosing your...
