Webinar Features
Overcoming Regulatory Challenges for Companion Diagnostic in Pharma Studies
This webinar explores the regulatory requirements for incorporating Clinical Trial Assays and Companion Diagnostics into pharmaceutical clinical studies. Learn best practices to navigate common challenges and ensure compliance throughout the development process.
Format
On-Demand Webinar
Level
Basic
Trainers
Kristiane Schmidt and Lorry Weaver
Exam
Certificate of Participation included
Duration
1 hour
Price
Free
Comprehensive Regulatory Expertise
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Watch on-demand webinars at your convenience, allowing you to fit learning into your schedule without missing essential information.
Flexible Viewing
Gain insights from industry experts and stay updated on the latest trends and regulations without the need to attend live sessions.
Access to Expertise
Meet the Trainer
Kristiane Schmidt
Kristiane is a senior consultant at Qserve Group with over 15 years of expertise in IVD product development, ISO & CE marking, risk management, and clinical trials, leveraging her strong technical background and passion for advancing medical technologies.
Meet the Trainer
Lorry Weaver
Lorry Weaver, MT(ASCP), CLS(NCA), Principal Consultant, is a seasoned expert in US Regulatory Affairs with over 30 years of experience supporting global medical device and in vitro diagnostic manufacturers, with a focus on companion diagnostics and next generation sequencing, through FDA submissions, CE marking, and international regulatory strategy.
