Course overview
In the rapidly evolving field of molecular diagnostics, understanding the regulatory and quality requirements is crucial for successful product development and market entry. This course is designed to equip participants with comprehensive knowledge and practical insights into navigating the regulatory and quality landscapes in the United States (US) and the European Union (EU), specifically tailored for PCR-based diagnostic tests.
Participants will delve into the intricacies of regulatory frameworks governing PCR-based diagnostic tests in both regions, including but not limited to:
- Overview of FDA (Food and Drug Administration) regulations applicable to PCR-based diagnostics
- Understanding the different pathways for regulatory approval or clearance (e.g., 510(k), Pre Market Approval, Emergency Use Authorisation)
- Requirements for clinical trials, and performance evaluation studies
- Recent updates and trends impacting regulatory pathways in the US
- Overview of CE marking requirements under the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation)
- Conformity assessment procedures and notified bodies in EU
- Post-market surveillance and vigilance requirements
The course will also address quality management systems essential for compliance with regulatory standards, such as ISO 13485 and Good Manufacturing Practice (GMP) guidelines. Regulatory expectations for quality control, risk management, cybersecurity and documentation will be covered to ensure participants gain a holistic understanding of designing, verifying and validating PCR-based tests for quality and regulatory compliance throughout the product lifecycle.
A review of two case studies will give participants the opportunity to see how the current regulatory environment applies to real-world scenarios, enhancing their ability to navigate challenges and optimise strategies for successful market entry of PCR-based diagnostic tests in the US and EU.
CPD Hours: 3
Course Content
- Day 1
- Navigating the US regulatory and quality landscape
- US case study and key takeaways
- Navigating the EU regulatory and quality landscape
Speakers
Dmitriy Kosarikov
After more than a 30-year career in R&D for the pharmaceutical and medical diagnostics industry, Dmitriy started the D&L Consulting, Education and Services LLC in 2023. Prior to that, he spent 23 years developing PCR tests and platforms at Roche Group - a company that had acquired the original PCR patent from Cetus in 1992 and soon after launched the first commercial PCR assay. During those years he had the privilege of learning from the giants like R. Saiki, D. Gelfand and H. Erlich, leading the teams developing three automated PCR platforms and being part of paradigm shift in cervical cancer screening. He also had the honour of serving as an R&D lead for a record breaking 37 days product development of the first high throughput PCR-based SARS-CoV-2 test in 2020.
