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.
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:

Webinar: 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 required by competent authorities in EU. The...

read more
Role of the Local Person for Pharmacovigilance (LPPV)

Role of the Local Person for Pharmacovigilance (LPPV)

The EU changes on the regulatory side have been significant. It has not only seen pharma companies face a new challenge to meet the requirements but also regulated medicinal products manufacturers, distributors and Pharmacovigilance professionals. The Local Person for...

All You Need To Know About Pharmacovigilance

All You Need To Know About Pharmacovigilance

Pharmacovigilance is the process of monitoring the safety and effectiveness of medications. The term was introduced in the early 1970s and evolved to include a broader range of activities. It's vital to ensure that patients have access to safe and effective drugs and...

Artificial Intelligence in Pharmacovigilance

Artificial Intelligence in Pharmacovigilance

Automation & AI in Pharmacovigilance: Promises and Realistic Expectations Recent years have seen increasing pharmaceutical companies' pharmacovigilance (PV)-related activities. The promise of artificial intelligence (AI) and automation is often mentioned as a way...

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.

Clinical Research

Regulatory Affairs

Pharmacovigilance

Medical Information