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:
Finalization of the European Database on Medical Devices (Eudamed) Regulation Implementation
There is an increased demand for Materiovigilance solutions in recent years as the usage of medical devices keeps growing. Current industry changes are already impacting future developments, and it is becoming more and more challenging to keep up with recent...
Download – ABO Whitepaper
Whitepaper Regulatory Affairs Outsourcing Affiliate-Based Outsourcing for Regulatory Affairs acts as an addition or replacement of your in-house local regulatory capabilities. However, it frequently falls short of meeting the requirements for effective organization,...
What is the Clinical Trials Regulation?
The EU CTR is the new Regulation that govers all interventional clinical trials using human medicinal products. By implementing this Clinical Trials Regulation (CTR) early 2022, the European Commission hopes to establish a better environment for clinical trials in the...
