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.

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This webinar focuses on learning:

Milestones in the journey towards the Affiliate-Based Outsourcing
Triggers and Reasons for the Regulatory Affairs ABO
Preparation for the ABO
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

Head of Regulatory Affairs

Successful Medical Device Registration in EAEU: New Legislation (Part 1)

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Webinar: Successful Medical Device Registration in EAEU: New Legislation (Part 1) The webinar discusses and explains the basic, essential, and theoretical matters of the EAEU system, outlines the new approach to the quality, safety, and efficacy assessments, and...

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

Apr 1, 2021

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.

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The interest of pharmaceutical companies in expanding business across CIS region has been constantly growing. For the same reason, Biomapas has expanded presence and now covers the whole CIS region, providing core services: clinical research, regulatory affairs,...

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Developing a Safety Management Plan (SMP) What is the Safety Management Plan (SMP)? This article explores all you need to know about the SMP for Pharmacovigilance and how you develop it. A Safety Management Plan (SMP) is a critical component of a comprehensive...

EMA & FDA: What Are the Similarities & Differences in Risk Management Procedures?

European Medicines Agency (EMA) and Food and Drug Administration (FDA) are regulatory bodies working in Europe and the United States of America, respectively, with their own approached to risk management procedures. They both aim to promote and protect public health...

Webinar: Setting up a pharmacovigilance system in Europe. Where to start? What to consider?

Setting up a pharmacovigilance system is not as straightforward an answer as it may sound. There are many aspects to consider, which can seem complicated, especially when you must focus on developing your product. In the first part of this webinar, our experts lay out...

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

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

Registering your MD in the EAEU?

Olga Bernardova

Other content that might interest you:

Successful Medical Device Registration in EAEU: New Legislation (Part 1)

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

Marketing pharmaceutical products in CIS countries / Eurasion Union

Developing a Safety Management Plan (SMP) for Pharmacovigilance

EMA & FDA: What Are the Similarities & Differences in Risk Management Procedures?

Webinar: Setting up a pharmacovigilance system in Europe. Where to start? What to consider?

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

Clinical Research

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Quality Assurance

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

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

Registering your MD in the EAEU?

Olga Bernardova

Other content that might interest you:

Successful Medical Device Registration in EAEU: New Legislation (Part 1)

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

Marketing pharmaceutical products in CIS countries / Eurasion Union

Developing a Safety Management Plan (SMP) for Pharmacovigilance

EMA & FDA: What Are the Similarities & Differences in Risk Management Procedures?

Webinar: Setting up a pharmacovigilance system in Europe. Where to start? What to consider?

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

Clinical Research

Regulatory Affairs

Pharmacovigilance

Medical Information

Clinical Trials

PV System & QPPV

Post-Authorization

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Small Enough To Care.