Affiliate Based Outsourcing for Regulatory Affairs

Practical tips on Affiliate Based Outsourcing including for Regulatory Affairsoptimization of local RA setup, management and relevant costs.

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

Olga Bernardova, MSc

Head of Global Regulatory Affairs

Other content that might interest you:

Saudi FDA’s New Pricing Guidelines and Impact on the Region

Saudi FDA’s New Pricing Guidelines and Impact on the Region

In a highly evolving regional pricing environment, Saudi Arabia (KSA) is no exception. The Saudi Food and Drug Authority (SFDA) has been periodically reviewing its pricing mechanisms and criteria so that the country becomes a regional reference for the prices of pharmaceutical products. What followed is a change in the pricing strategy by SFDA and a shift from price takers to price makers.

read more
Expert Guidance on PSURs: Ensuring Drug Safety

Expert Guidance on PSURs: Ensuring Drug Safety

The pharmaceutical industry constantly evolves, with new drugs being developed and approved daily. One critical aspect of ensuring the safety and efficacy of these medications is the periodic assessment of their risk-benefit profile. Enter Periodic Safety Update...

Literature Monitoring in Pharmacovigilance

Literature Monitoring in Pharmacovigilance

Incorporating data from medical and scientific literature is a paramount aspect of patient safety. This wealth of knowledge often constitutes a substantial part of the safety profile of medicinal products. From providing insights on potential side effects to shedding...

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

Discover how Biomapas provides all the support to accelerate your clinical trials and optimize your drug development process.

Clinical Research

Reliable support for every phase of your clinical trial, from recruitment to results.

Pharmacovigilance

Flexible safety monitoring to keep your products compliant and trusted.

Regulatory Affairs

Confidently navigate regulatory challenges with expert support.

Medical Information

Clear, accurate medical information 24/7, tailored for global audiences.

Quality Assurance

Export auditors help identify gaps and close them with actionable solutions.