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:
Medical Device Registration in Russia. Challenges and Issues
Webinar: Medical Device Registration in Russia. Challenges and Issues The purpose of this webinar is to show the differences and specifics of regulations and law processes that can cause challenges in medical device registration in Russia. You will learn about:...
eCTD Submission Strategies: In-house vs. Outsourcing
Webinar: eCTD Submission Different Strategies: In-house vs. Outsourcing eCTD Submission Strategies, including outsourcing, are influenced by varying requirements in various regions and countries. That and diverse technical resources by companies often lead to various...
Drugs serialization and barcoding in Saudi Arabia and MENA region
An increasing number of countries worldwide have enacted regulations mandating serialization, tracking and tracing of pharmaceutical products down the supply chain during recent years as a response to drug integrity concerns. There are plenty of laws requiring...
