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:

Proper Publicizing in CEECs – Path to Successful Social Media Commercials

Proper Publicizing in CEECs – Path to Successful Social Media Commercials

With the growth of social media network users all over the world, there is no doubt that one of the most widely used channels for promoting is social media. Statistics show that Facebook and Instagram were used actively with more than 3.4 billion people daily by January 2020. Therefore, since medical devices and over-the-counter medicines are being more often promoted by commercials on social media nowadays, there is a greater risk of hidden or misleading advertisements.

read more
How Mergers and Acquisitions of Pharma Companies affect Regulatory Affairs?

How Mergers and Acquisitions of Pharma Companies affect Regulatory Affairs?

It is easy to notice that Mergers and Acquisitions (M&A) have become a frequent occurrence in the Pharmaceutical industry, especially during the previous decades. Pharma industry is one of the leading industries in the number of M&A and the size of investments for such transitions. The value for M&A in the pharmaceutical sector was $221 billion in the first half of the year 2015. In 2019, the worth of pharma companies M&A activities have reached $357 billion.

read more
CMC: Best Practice in Effective IND and IMPD writing

CMC: Best Practice in Effective IND and IMPD writing

This time we will focus on technical writing and preparation for it. Also, I will provide some primary recommendations for CMC writers. The IND/IMPD being a regulatory document, has the same structure as CTD dossier. However, it includes remarkably less information on the developmental product, yet, the technical writers should understand that they will need to prepare the document in the way to reflect the actual production process and control further during the development in the later clinical phases.

read more
The CIS Region: Excellent Potential for Patient Recruitment but is there any Risk to Quality?

The CIS Region: Excellent Potential for Patient Recruitment but is there any Risk to Quality?

The number of clinical trials worldwide is increasing more than 10% each year due to the new diseases, further research for better health products and development of new drugs. Though, for a successful clinical trial, there is a major challenge – patient recruitment, which is essential and the most challenging factor due to the increasing number of new clinical trials. In order to achieve the required patient recruitment, sponsors are looking for different solutions.

read more
Running a clinical trial in the Baltic states

Running a clinical trial in the Baltic states

In the past five years, an average of 175 clinical trials are being initiated in the Baltic states each year. An average of 64,8% of the population in the Baltic states are in the age from 15 to 65 years old, the main target audience for clinical trials. Furthermore, a large pool of treatment-naïve subjects is available compared to other EU countries or the US. Patients with special therapeutic diseases are transferred to the main central hospitals.

read more
Remaining Vigilant and Compliant after Brexit: What’s next? (Latest Updates)

Remaining Vigilant and Compliant after Brexit: What’s next? (Latest Updates)

On 29th March 2017 UK submitted the notification of its intention to withdraw from the EU. This means that UK will become a ‘third country’ from 30th March’19. Even though leaving the EU with a deal remains the Government’s top priority, UK drug agency is publishing a series of guidance documents for industry and other stakeholders covering the proposed arrangements for the regulation of medicines, medical devices and clinical trials, if UK leaves EU with no deal.

read more

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