Webinar: Different Affiliate-Based Outsourcing Models for Regulatory Affairs
Often questions arise about the Affiliate-Based Outsourcing (ABO) Models for Regulatory Affairs:
1. How can it fit your specific needs?
2. How can it adapt to your organization and setup?
3. What are its possibilities of adjusting to your portfolio?
The purpose of this webinar is to share insights on the Regulatory Affairs Affiliate-Based Outsourcing Model’s flexibility and practical tips on how it can be tailored to your needs. We will share examples of different scenarios on how the ABO model can be customized to optimize costs and efficiently manage your local regulatory operations.
Expanding across Europe?
Make use of our experience. Explore your options in an informal chat with one of our experts.
This webinar focuses on learning:
- What are the options for the Affiliate-Based Outsourcing Model for Regulatory Affairs.
- What are the benefits of different models.
- What are the common challenges and how to overcome them.
- How to select the most beneficial Affiliate-Based Outsourcing Model for you.
Duration: 30 minutes
Speaker: Head of Regulatory Affairs, Olga Bernardova.
Olga Bernardova
Head of Regulatory Affairs
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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.
