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:
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.
