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Formazione >> Webinar e Formazione Online >> Viral safety – An overview of regulatory landscape and testing strategy

Viral safety – An overview of regulatory landscape and testing strategy

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FREE ONLINE WEBINAR: To continue supporting our customers' needs this webinar is dedicated to manufacturers only. To allow all interested companies attend, maximum two delegates form the same company will be admitted. Due to the type of event and limited audience capacity, participation of companies not included in this category will not be accepted. Attendance will be confirmed from the event's organizers.

DATE: May 30, 2023 | 3.00 PM - 4.00 PM CET

OFFICIAL LANGUAGE: English

SUBMISSION LINK: https://register.gotowebinar.com/register/4495469169320242006

ATTENDEES CAPACITY: 250 delegates

The event will be hosted within Go ToWebinar platform. Your registration request for this webinar will be submitted to the organizer for approval. You will receive information via email regarding your registration status.

Introduction

Viral safety is a great concern when developing and producing a biological product, especially for those whose manufacture has involved the use of material of human and animal origin.

 

For such products, absence of viral contamination must be demonstrated according to current regulations since viral safety is required for clinical phase, marketing authorisation and Batch/Lot release.

 

Indeed, the risk of viral contamination is a feature common to all biotechnology product derived from cell substrates such as monoclonal antibodies and recombinant DNA-derived products as well as gene therapy products.

Moreover, cell substrates (e.g MCB) are not the only source of contamination as adventitious virus might be unintentionally introduced during production of biological medicines.

In this context, risk assessment and testing strategy are key elements to address this issue.

 

The aim of the webinar is to provide an overview of regulatory aspects of viral safety with a focus on risk assessment and testing; in particular:

-Requirements according to current regulation

-What to consider for risk assessment

-Recommended Virus Detection and Identification Assays

Speakers

Luca Benedan has a master degree in Medical Biotechnology and Molecular Medicine. After his studies, Luca started working in Eurofins BPT in Milan as a Biotech Laboratory Technician before becoming Project Leader in the Biologics Biotech&Micro division, leading the biosafety area. In 2022, he joined ERCSI, working as consultant in Pharma division with a focus on biological products and microbiology.

Silvia Ferrari is the Project Leader of Biotech-Viral Safety team at Eurofins BPT in Milan, Italy. After her master’s degree in Medical Biotechnology, she earned her PhD in Translational Medicine, working in the academic research for several years and achieving a solid cellular-molecular biology background. In 2022 she joined Eurofins Biolab dealing with Viral safety studies design and execution in compliance with current guidelines.

Agenda
  • Introduction – Risk and sources of viral contamination
  • Regulatory background
  • Viral safety risk assessment
  • Viral safety testing
  • Conclusion and take home message
  • Q&A session