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:
CMC: Effective Writing of IND and IMPD
Do we truly know how to ensure IND or IMPD Quality (CMC) part is written in good quality, consistent and clear technical language? How to effectively manage the writing process? In this article, I will focus on these questions and the initial IND/IMPD, required to start clinical investigations in humans. Furthermore, I will provide the key features and practical advice on how to deliver effectiveness. Firstly, we have to define the team in order to understand if the organization has capabilities to do CMC writing in-house or needs to outsource.
Biomapas appoints Head of Global Regulatory Affairs
May 2020 – Olga Bernardova joins Biomapas as Head of Global Regulatory Affairs to lead the regulatory affairs department and to ensure the best processes and means to serve Biomapas growth and international expansion. As a functional and full outsourcing solution provider, with offices in Lithuania, Switzerland, Sweden, Russia, Georgia, Ukraine, Poland and Kazakhstan, Biomapas continues to expand its international team and further increases capabilities for client-oriented solutions.
Regulatory Documents Translation Process – How to Ensure Consistency and Correctness
Mistranslation of regulatory documents such as a summary of product characteristics, product information leaflets and instructions for use, could have a negative impact for the company and most importantly could lead to serious consequences to a patient’s health. In 2007, as a result of inaccurate translation, 47 patients had badly implanted knee prostheses. An outer package labelled in English included different information.
