Quality & Regulation Track
Sponsored by:
Moderator: Sarit Gal-Rom, CEO, HaMaDa Consultants
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Michael (Moshe) Kasser
Senior Director of Regulatory Strategy
Hogan Lovells
12:00 - 12:20
How FDA’s New eSTAR Requirement is Affecting Industry
Since the start of the FY2024, FDA has required the 510(k)s be submitted using their eSTAR format, which is a smart electronic form. While this format standardizes where specific information can be found, it has also resulted in the need for more documentation and testing, particularly for biocompatibility, software, cybersecurity, and electrical testing. This lecture informs companies of FDA’s new expectations.
BIO:Michael (Moshe) Kasser has been involved in the regulation of medical devices since he obtained his Ph.D. in materials science and engineering. Michael brought a powerful and unique blend of the regulatory know-how and technical understanding required to comprehend and address the FDA's scientific concerns with novel technologies. He uses his knowledge and communications skills to assist medical device companies to clear FDA hurdles and bring novel technologies to the U.S. market. This includes cutting edge technologies such as brain/computer interfaces, robotic surgical systems, cartilage replacement devices, wearable sensors, digital health, and many others.
12:20 - 12:40
PMCF Strategy for Successful Clinical Evidence
The lecture addresses the challenges that many biotech companies face in collecting of post marketing clinical follow up (PMCF) data. It discusses the strategy of ongoing monitoring of product performance, safety, and efficacy in real-world settings, aimed to ensure continuous evaluation of a product's benefits and risks in clinical practice. Discussions include methods for designing and implementing of PMCF studies, clinical publications and budgeting as well as the importance of post marketing clinical data for marketing stakeholders, physicians, and marketing representatives.
BIO:
Dr. Naida Gurshumov (PhD) is a professional clinical research consultant with more than 25 years of experience in clinical research industry, gained from local and international CROs, pharma and biotech companies. During these years Dr. Gurshumov has managed and led clinical projects of different complexity in all major therapeutic areas, including but not limited to clinical studies planning, management, auditing, documentation, regulatory submissions to US and European authorities, development of clinical strategies and intense Clinical & Medical Writing.
Dr. Naida Gurshumov, PhD
Clinical Consultant
HaMaDa Consultants
12:40 - 13:00
FDA's QMSR - Understanding the harmonization of 21CFR 820 and ISO13485
Liat Aharon Pollak
Director Of Regulatory Affairs
R.S NESS Group
The harmonization of 21 CFR Part 820, the Quality System Regulation (QSR) for medical devices as mandated by the U.S. Food and Drug Administration (FDA), with ISO 13485 represents a significant stride towards global regulatory alignment. This harmonization effort is aimed at simplifying the compliance process for medical device manufacturers, by reducing redundancies and ensuring that the requirements for quality management systems are consistent across different jurisdictions. The goal is to enable manufacturers to develop a single quality management system that meets both the requirements of 21 CFR Part 820 and ISO 13485, thereby facilitating easier access to multiple markets.
For manufacturers, this harmonization can lead to efficiencies in the development, implementation, and maintenance of their quality management systems, reducing the complexity and cost of compliance. It also aids in enhancing product quality and safety by fostering a more coherent and unified approach to quality management across the global medical device industry. In this presentation I will provide an overview of the QMSR final rule and its alignment with ISO 13485, and discuss practical steps for manufacturers to navigate the transition to QMSR.
BIO:
Liat is a seasoned regulation and quality assurance professional, with extensive experience in medical device and pharmaceutical industries. In her role as the director of regulatory affairs in RS NESS she leads regulatory processes in medical device companies, and supports companies in achieving compliance with regulatory requirements, including FDA’s Quality Management System Regulation (QMSR) requirements.
Dina Sifri
Founder and CEO
MedDev Soft
13:00 - 13:20
The FDA & EU Artificial Intelligence Directive and the Implication for Medical Device Manufacturers - New and Coming Standards for AI/ML in Medical Devices
The FDA's recent approval of over 700 AI and ML medical systems has highlighted the urgent need for standardized development guidelines and safety regulations. In response, regulatory bodies, academia, and industry are collaboratively working to establish clear safety requirements and processes. This concerted effort aims to ensure patient safety and the effectiveness of AI-based treatments, despite the inherent challenges and risks. In the upcoming lecture, we will explore the regulatory innovations in the USA and Europe, focusing on integrated AI systems, risk management, and upcoming standards, providing crucial insights into the evolving landscape of AI and ML in healthcare.
BIO:
Dina Sifri is a seasoned expert in medical devices and digital health software development and regulation. With decades of experience, she has guided hundreds of companies through the nuances of software, cybersecurity, and regulatory compliance. Dina has been instrumental in hundreds of medical product submissions and has extensive experience in implementing and auditing software standards, QMS, and ISMS systems. As an Israeli representative in ISO forums and a member of eight committees in AAMI, her contributions span across cyber, software, usability, software risks, information security, and AI/ML fields.
13:20 - 14:20 : Lunch, Exhibition Visit
Daniel Kleinberg
QARA Cyber Expert
Matrix Medika
14:20 - 14:40
How to CYBER a Product for FDA
The world of cybersecurity keeps growing and growing, bringing with it new opportunities and challenges on a daily basis. Up until now, the FDA moved alongside it, but in the last few months, Everything has changed, and the marathon has become a sprint.
How do you effectively and intelligently cyber a medical product for the FDA? This lecture will help you better understand what to do.
BIO:
Daniel Kleinberg is a QA/RA Cyber expert in Matrix Medika, a role in which he specializes in cybersecurity implantation in the medical world while combining a QA tester's constantly challenging mindset with the total system-level view of a Regulation man.
A graduate of Tel Aviv University and John Bryce College, 35 Years old from Pardes Hanna, married to Shahaf, and the proud father of Bree the dog.
14:40 - 15:00
Change The Study Protocol To Rescue A Trial - When/Why/Challenges
Protocol modification/amendments may be necessary to rescue a trial or respond to changed circumstances, in this presentation we will review the reasons, key challenges, the underlying problems that cause them and ways to avoid it.
BIO:
Ronit has over two decades of experience in Clinical Trials, both in the scientific side and in operations. Early in her career, she served as Head of the Clinical Department of two large international pharmaceutical companies, MSD and Actelion. During her career she served as Director & Clinical Leader in Teva R&D department. Ronit joined Cordio Medical in 2018 and holds a PhD in Life Sciences from Tel-Aviv University.
Dr. Ronit Haviv, PhD
SrVP Clinical and Regulation Affairs
Cordio Medical
Israel A. Citron MBA, MSc.
VP Regulatory Affairs and Quality Assurance
Pulsenmore
15:00 - 15:20
Brazil Carnival Experience – The Regulatory Clearance of the Pulsenmore ES in Brazil
Brazil is the largest market in South America for Medical Devices and for “Home Ultrasound” in particular.
We will cover the regulatory strategy Pulsenmore developed to gain registration of the Pulsenmore ES Home Ultrasound system in Brazil.
The regulatory requirements of ANVISA INMETRO and ANATEL we had to comply with, and the preparation of the technical dossier(s) associated with the submissions.
A few tips and best practices to consider when conquering this new and exciting territory.
BIO:
Over 25 years of experience in management of regulatory affairs and quality assurance in corporate and startup medical device companies.
Active participant in international standardization organizations.
MSc in Electrical Engineering, Technion - Israel Institute of Technology; MBA, Tel Aviv University.
Ruthie Amir, MD
Chief Medical Officer
SofWave Medical &Epitomee Medical
15:20 - 15:40
Nothing is Regular in Regulation
Sharing experience and challenges in FDA submissions and global market regulatory registration. Interesting cases and lessons to learn will be presented.
BIO:
Chief Medical Officer of SofWave Medical; Chief Medical officer of Epitommee Medical.
Former Global Vice President of Clinical and Regulatory Affairs at Syneron- Candela. Research Fellowship on Molecular Genetics, Baylor College of Medicine, Texas, USA