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.
Areas Covered in the Webinar:
Who Will Benefit:
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.
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