Biomapas Logo
Contact us
a
cropped-favicon-biomapas.png
Contact us
a

How to prepare for Affiliate-Based Outsourcing for Regulatory Affairs?

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?

Make use of our experience to facilitate the approval process. Explore your options in an informal chat.
Let's Talk
This webinar focuses on learning:

  1. Milestones in the journey towards the Affiliate-Based Outsourcing
  2. Triggers and Reasons for the Regulatory Affairs ABO
  3. Preparation for the ABO
  4. 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

Olga Bernardova

Head of Regulatory Affairs

Other content that might interest you:

Expediting access through Reliance Pathways: MENA region

Expediting access through Reliance Pathways: MENA region

Mar 16, 2021

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 (MENA) region have implemented the Abridged and Verification reviews. These regulatory procedures allow the approvement of needed innovative and/or life-saving drugs.

read more
Webinar: eCTD Submission Strategies. In-house vs. Outsourcing

Webinar: eCTD Submission Strategies. In-house vs. Outsourcing

Mar 13, 2021

eCTD Submission Strategies, including outsourcing, are influenced by varying requirements in various regions and countries. That and diverse technical resources by companies often lead to various regulatory strategies. Thus, the questions arises: how to choose the...

read more
How does the Russian invasion impact the pharmaceutical industry?

How does the Russian invasion impact the pharmaceutical industry?

Like the rest of the world, the pharmaceutical and biotech industries are beginning to worry about their ability to continue operations. And, with good reason. Russia's invasion of Ukraine affects millions of people, not just in this Eastern European nation but...

Biomapas Announces Two New Appointments to Board of Directors

Biomapas Announces Two New Appointments to Board of Directors

February 2022 Biomapas, a full spectrum clinical, regulatory, pharmacovigilance and medical information solution provider, is pleased to announce the two new members joining its board of directors. Coming from life science, biopharmaceutical and financial industries,...

Affiliate Based Outsourcing

Affiliate Based Outsourcing

Whitepaper Regulatory Affairs Outsourcing Affiliate-Based Outsourcing for Regulatory Affairs acts as an addition or replacement of your in-house local regulatory capabilities. However, it frequently falls short of meeting the requirements for effective organization,...

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