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Webinar

Safety reporting in clinical trials: six core considerations for success

23 April 2025

2:00pm

Join this webinar for guidance in navigating the terrain of pharmacovigilance, including regulatory challenges, and gain a deeper understanding of the pivotal role played by safety reporting in clinical research.

This webinar delves into the complex and evolving world of safety reporting in clinical trials, uncovering regulatory and ethics challenges that sponsors face. 

In the clinical trials realm, patient safety is the paramount concern.

As investigational products progress through the phases of clinical research, the pharmacovigilance landscape becomes an intricate global network, demanding continuous adaptation, meticulous planning and expert execution.

Join this webinar for insights into achieving safety reporting compliance, discerning country-specific idiosyncrasies, adapting to the electronic reporting era, and embracing pharmacovigilance regulatory intelligence as a guiding principle amidst regulatory changes.

By exploring these considerations, stakeholders in clinical research, from pharmaceutical companies to clinical investigators, gain a comprehensive perspective on the intricacies of safety reporting.

This knowledge equips them to navigate the multifaceted challenges, uphold rigorous standards of patient safety, and ensure unwavering adherence to regulatory requirements throughout the clinical trial journey.

Key learning points: 

  • Insight into delivering safety reporting to investigators
  • Considerations when managing multiple clinical vendors
  • Achieving compliance in safety reporting
  • Find out about country-specific nuances in safety reporting
  • Guidance on adapting to and navigating electronic reporting requirements
  • How to use pharmacovigilance regulatory intelligence as a guide amidst changes in regulation.

OUR SPEAKERS

Jessica Brown

Jessica Brown – Director PPD FSP Pharmacovigilance solutions

For the past ten years, Jessica has been responsible for all safety report submissions including ICSRs and aggregates. Jessica has worked in the field of drug safety for over 17 years and holds a Master of Science Degree in Organizational Communication from NC State University, US.  

Mayna Fukushima

Mayna Fukushima – Associate Director Pharmacovigilance, PPD clinical research business, Thermo Fisher Scientific 

Mayna Fukushima has over 19 years of experience in the pharmaceutical industry, including 17 years specializing in pharmacovigilance within clinical trials. She joined Thermo Fisher Scientific’s Clinical Research Group PPD, in 2021 with extensive experience leading multicultural teams and managing safety activities for a wide range of studies and sponsors. Mayna holds a Bachelor’s Degree in Pharmacy-Biochemistry and a Graduate Diploma in Business Management with a focus on Marketing. She is currently pursuing an Executive MBA at Valar Institute.

FAQs

FAQs 

Is the panel discussion free? 

Yes – there is no charge to watch the panel discussion, either live or on-demand. 

When will the panel discussion take place? 

23 April at 3pm BST.

Can I watch it later? 

The panel discussion will become available to watch on-demand shortly after the live webinar takes place. 

What are the benefits of attending live? 

You’ll be able to ask the speakers your questions, which will be answered live in the Q&A towards the end of the session. 

How long will the panel discussion be? 

This panel discussion will last up to an hour. 

What do I need to watch this panel discussion? 

All you need is a computer with an internet connection. We recommend using headphones if possible if you’re in an office environment.