Webinar: How to prepare for Affiliate-Based Outsourcing for Regulatory Affairs?
Affiliate-Based Outsourcing (ABO) Model for Regulatory Affairs works as a replacement or an extension of the company’s internal and local RA resources, which are often insufficient for the effective organization and execution of regulatory activities. The essential element for the successful implementation of the ABO model is the company’s readiness for this change. The purpose of this webinar is to share the key steps and practical tips on the preparation for Affiliate-Based Outsourcing for Regulatory Affairs.
Registering your MD in the EAEU?
- Milestones in the journey towards the Affiliate-Based Outsourcing
- Triggers and Reasons for the Regulatory Affairs ABO
- Preparation for the ABO
- Key elements you should consider while getting ready for the Regulatory Affairs ABO
Duration: 50 minutes
Speaker: Head of Regulatory Affairs, Olga Bernardova.
Olga Bernardova
Head of Regulatory Affairs
Other content that might interest you:
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...
CMC: Effective Writing Of IND And IMPD
This artical focuses on best practices in delivering an effective CMC writing strategy when writing an IND or IMPD.
