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:

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 (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

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
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