Navigating Regulatory Compliance Whilst Developing and Distributing PCR-Based IVD Tests In-house Training

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), PMA, EUA)
• 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 knowledge 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.

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

Benefits of attending

• Gain the confidence and knowledge necessary to effectively navigate the complex regulatory and quality landscape of the US
• Learn the EU regulatory and quality landscape
• Accelerate the development and commercialisation of PCR-based diagnostic tests
• Ensure compliance with evolving regulatory requirements
• Participate in case studies and group discussions

Who should attend?

• Professionals involved in the development, regulatory affairs, quality assurance, or manufacturing of PCR-based diagnostic tests
• Researchers, scientists, and entrepreneurs aiming to bring innovative diagnostic technologies to market
• Consultants and advisors seeking to expand their expertise in regulatory affairs and quality management within the diagnostic industry