The Regulation of in-house IVDs and accreditation of laboratory users in Australia
Instructor:
Paul Cohen
Product ID: 706155
Training Level: Intermediate to Advanced
- Duration: 75 Min
Why Should You Attend:
'In-house' IVDs are pathology tests that have been developed (or modified) within a laboratory (or laboratory network) to carry out testing on human samples, where the results are intended to assist in clinical diagnosis or be used in making decisions concerning clinical management.
Laboratories, the Therapeutic Goods Administration (TGA) and the National Association of Testing Authorities (NATA) are involved in ensuring the regulatory requirements of in-house IVDs are met. This seminar explains how laboratories that manufacture in-house IVDs can meet these requirements.
Learning Objectives:
- To understand the definitions of in-house IVDs
- To understand the regulatory requirements (including classification and Essential Principles) specific to IVDs
- To understand the laboratory accreditation (NATA) requirements related to how and when IVDs can be used as a research or diagnostic tool
- To understand current laboratory supervision requirements for ability to perform and report on in house IVDs
Areas Covered in the Webinar:
- The definitions of in-house IVDs
- The regulatory requirements (including classification and Essential Principles) specific to IVDs
- Laboratory accreditation (NATA) requirements related to how and when IVDs can be used as a research or diagnostic tool
- Current laboratory supervision requirements for ability to perform and report on in house IVDs
- Conformity assessment pathways
- TGA auditing requirements
- Genetic tests as in-house IVD
- Regulation of software as part of in house IVDs
Who Will Benefit:
- Manufacturers of in-house IVDs
- Regulatory associates/managers/directors of start- up companies or large corporations.
- Pathology scientists or laboratory managers/directors
Paul Cohen
Founder and Principal Consultant, Paul Cohen Consulting
Paul has greater than 26 years experience in the diagnostics, biotechnology, medical device and bio-pharmaceutical industry. His expertise spans clinical research, regulatory affairs, pharmacovigilance, training, quality management and process re-engineering for large pharmaceutical companies, biotech and start-up ventures.
He has worked for large pharma companies including Wyeth, Merck Sharp and Dohme, Novo Nordisk and Janssen-Cilag; start up ventures: including Sanofi Pasteur and IBAH (the CRO now known as Omnicare) and Columna. He has managed in excess of 20 Phase I-IV clinical and health outcome projects, both locally and globally.
His clinical research therapeutic area expertise includes vaccines and biological, anti-infectives, transplantation, antidepressants, rheumatology, oncology, diabetes, respiratory and orthopaedics.
He is the Principal Consultant and Director of his own boutique-consulting practice (since 2000) in clinical research, regulatory, quality and project management. He has assisted many Australian start-up companies with their clinical research, regulatory and quality strategies and taken then from concept, through clinical phases to regulatory approval and quality certification.
Paul has regulatory and compliance expertise in ICH GCP, ISO 14155, ISO 9001, ISO 13485, ISO 17025 (GLP) and GMP.
He holds an ARCS Certified Fellowship in Clinical Research and is a member of ARCS, AIMS, ASM, RAPS and a Subject Matter Expert for the World Medical Device Organisation.
He is actively involved as a mentor to PhD students as part of the IMNIS (Industry Mentoring Network in STEM) partnering with MTP Connect for the past 3 years.
He helped develop the (MHTI) Master of Health Technology Innovation post-graduate course at Sydney University/Charles Perkins Centre and lectures on regulatory/quality topics each year.
Paul is also completing a Cert IV in life and business coaching.
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
