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Thursday, April 12 • 8:30am - 10:00am
Session HH - Medical Device Track

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HH-1   EU-MDR QMS Strategy

In the past year, many changes to quality management system (QMS) establishment, maintenance and documentation have impacted the medical device and diagnostic industry. The European Union Medical Device Regulation (EU-MDR) mandates that the QMS should set high standards and support quality beyond satisfying compliance requirements for performance safety and outcomes. As well as establish a risk-based approach to the overall QMS process. This will add to planning and training on changes across the entire quality system with the addition of new SOPs, manuals and reporting functions. Aligning QMS with the new regulatory requirements require increased resources to maintain its management.
  • Review of EU MDR specifics for QMS strategy revision
  • Practical implementation tips

Medical Device

Level of Content:

HH-2  US FDA 21 CFR Part 58 Good Laboratory Practice, Proposed Rule and Its Impact to Japanese Medical Device Industries

Nonclinical study in compliance with Good Laboratory Practice (GLP) should be conducted to confirm safety prior to perform any clinical investigation of pharmaceuticals, medical device, or HCT/Ps. In the US, 21 CFR Part 58 GLP is regulated to conduct the nonclinical study as well as Ministerial Ordinance of GLPs in Japan. Furthermore, Organization for Economic Co-operation and Development (OECD) principles of GLP have been created in the context of harmonizing testing procedures for the Mutual Acceptance of Data (MAD). Under current regulatory landscape, the United States Food and Drug Administration (US FDA) was issued the proposed rule (Federal Register, Vol. 81, No. 164, August 24, 2016). The purposes of this study are to confirm the background and content of proposed rule, and to consider the regulatory influence of GLPs in Japan.
As background, the proposed rule of US FDA GLP needs to introduce the Animal Rule for pharmaceutical and biological products, to establish the GLP quality system in compliance with ISO 9001, and to newly develop the clause of Animal Welfare policy. Gap analysis on both GLPs between Japan and the US revealed that none of description on veterinary care and attending veterinarian exist in Japan. If site inspection of Bioresearch Monitoring Program conducts in Japan, some nonclinical facility may be issued on the GLP deviation due to lack of description on animal welfare. As of this moment, only GLP facilities which received the AAALAC International accreditation are available to apply the revised 21 CFR Part 58 in Japan.

Medical Device

Level of Content:

HH-3  Challenges with Interpreting the GLPs for Medical Device Studies

The Code of Federal Regulations 21 CFR Part 58 provides Good Laboratory Practice regulations for non-clinical laboratory studies. These regulations were originally created to provide guidelines for conducting non-clinical studies for pharmaceutical products; however, they now cover a broader scope which includes food additives, biological products, and medical devices. In the realm of medical devices, there is a lack of clarity on how to best apply these regulations, especially for biocompatibility studies. Due to the current broad scope of products for which the GLP’s may be applied, medical device professionals are left to interpret the language of these regulations, using their best judgment to determine how to sufficiently address each requirement. Some common challenges include determining when to conduct a medical device study as GLP, and also determining what test article characterization data is required when conducting a GLP study.

Good Laboratory Practices - FDA

Level of Content:

avatar for Bethany Davis

Bethany Davis

Bethany has over twelve (12) years of experience in the pharmaceutical and research industry. Before joining Clinlogix, Bethany’s experience includes McNeil Consumer Healthcare, Dr. Reddy’s Laboratories and The Commonwealth Medical College.  Bethany has designed and implemented... Read More →

avatar for Autumn Lang

Autumn Lang

Autumn partners with emerging medical device teams by aligning all their various expertise to have the same commercial objectives and goals. With her 18 years of operational and consulting experience in the medical device industry and clinical research, she has successfully led many... Read More →
avatar for Tiffany Sam

Tiffany Sam

Edwards Lifesciences
Tiffany Sam is a biologist and study director for biocompatibility studies at Edwards Lifesciences, the global leader in patient-focused medical innovations for structural heart disease. She draws upon her 9 years of experience working for a rapidly growing medical device company... Read More →

Masayuki Yamato

Tokyo Women's Medical University
avatar for Kazuo Yano

Kazuo Yano

Part Time Assistant Professor, Tokyo Women\'s Medical University
Kazuo Yano received his DVM from the Graduate School of Veterinary Medicine, Hokkaido University, and PhD from the Cooperative Graduate School of Tokyo Women's Medical University and Waseda University. He is a Part Time Assistant Professors at both Universities. He has published 20... Read More →

Thursday April 12, 2018 8:30am - 10:00am PDT
Platinum 7&8