Biomapas Logo
cropped-favicon-biomapas.png

Different Affiliate Based Outsourcing Models for Regulatory Affairs

Different Affiliate Based Outsourcing Models for Regulatory Affairs

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.

Let's Talk

This webinar focuses on learning:

  1. What are the options for the Affiliate-Based Outsourcing Model for Regulatory Affairs.
  2. What are the benefits of different models.
  3. What are the common challenges and how to overcome them.
  4. How to select the most beneficial Affiliate-Based Outsourcing Model for you.

Duration: 30 minutes

Speaker: Head of Regulatory Affairs, Olga Bernardova.

Olga Bernardova

Olga Bernardova

Head of Regulatory Affairs

Other content that might interest you:

Biosimilars in the MENA Region: Regulatory Landscape

Biosimilars in the MENA Region: Regulatory Landscape

Apr 27, 2021

Regulatory affairs for biosimilars in Middle East North Africa (MENA) region are evolving as existing guidelines and regulatory frameworks are being updated. Since European Medicines Agency (EMA) introduced a legal pathway for biosimilars approval in 2004, several...

read more
CMC: Effective Writing Of IND And IMPD

CMC: Effective Writing Of IND And IMPD

Do we truly know how to ensure a well-written IND or IMPD Quality (CMC) part? Consistent and clear technical language? How to effectively manage the writing process? Biomapas can help you answer these questions and to set up the initial IND/IMPD required to start...

Effective IMPD Writing. The Quality Part

Effective IMPD Writing. The Quality Part

Webinar: Effective IMPD Writing. The Quality Part Effective IMPD writing, including the quality part is a vital document that contains information about an investigational medicinal product and it is an essential part of the Clinical Trial Application (CTA), which is...

Medical Device Registration in Russia. The Essentials

Medical Device Registration in Russia. The Essentials

Webinar: Successful Medical Device Registration in Russia. The Essentials The current national system for Medical Device registration in Russia was created from scratch and entered into force in 2013. Most experts agree that this system is complex and puzzling – some...

Expediting access through Reliance Pathways: MENA region

Expediting access through Reliance Pathways: MENA region

Reliance models are review pathways used by Regulators to expedite the patient access to essential pharmaceutical products and to overcome resource constraints and priorities.   Recently, several National Competent Authorities (NCA) in the Middle East North Africa...

Big Enough To Cover  All Your Needs. Small Enough To Care.

Discover the tailored solutions that Biomapas provides to accelerate your clinical trials and optimize your drug development process.
Affiliate-Based Outsourcing
CSV For Pharmacovigilance Systems
Early Phase Oncology
Functional Service Provision
M&A Support

Clinical Research

Read more

Regulatory Affairs

Read more

Pharmacovigilance

Read more

Medical Information

Read more