Sponsored by:
Complimentary Virtual Event Recording
Recorded on January 18, 2023 | 12:00 p.m. - 2:30 p.m. EDT
MedTech Regulatory Intelligence: Post-Market Surveillance
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Post-market surveillance has become an increasingly important area of focus in both U.S. FDA and EU regulations. In this webinar, we will take a closer look at the challenges of developing sustainable post-market surveillance processes, as well as how companies are addressing these challenges and using new tools to track product safety and performance post market.
AGENDA
12:00 pm - 12:05 pm - Welcome and Introduction
Inga Hansen, Managing Editor, MedTech Intelligence
12:05 pm – 12:30 pm - Systematic Literature Reviews: How Medtronic Developed a More Efficient and Standardized Process
Queenita Fernandes, Sr. Medical Safety Manager, Medtronic
12:30 pm – 1:10 pm - Adverse Events in the Digital Age and Where to Find Them
Robert Di Giovanni, Global Project Safety Lead, Novartis
1:10 pm – 1:25 pm - TechTalk: 2023 Post-market Predictions
Adam Price, Director of Product - Post-Market, Rimsys
- Understand the basics of post-market surveillance vs post-market vigilance
- Be aware of post-market regulatory changes that could impact device manufacturers in the coming year
- Identify specific steps your organization can take to prepare for post-market reporting and EUDAMED rollout
1:25 pm – 1:50 pm - EU IVDR: Working With Notified Bodies and Key Certification Challenges
Carlos Galamba, Vice President of IVD Intelligence & Innovation, RQM+
1:50 pm – 2:15 pm - Working with the FDA on Recalls
Ashley Kelleher, Sr. Medical Device Consultant, NSF
2:10 pm - 2:25 pm - TechTalk Sponsored by HUMA.AI
Lana Feng, PhD, Co-Founder & CEO, HUMA.AI
- Learn how to integrate diverse data sets using machine learning to empower post-market surveillance professionals and ease the PMS burden for medical device and IVD manufacturers.
2:25 pm - 2:30 pm - Final Thoughts and Closing
SPEAKERS
Queenita Fernandes
Sr. Medical Safety Manager
Medtronic
Queenita has 18 years of experience in the healthcare industry. Her expertise includes medical safety, regulatory writing, complaint handling and clinical research. In her current role as Medical Safety Manager, she and her team focus on post-market literature surveillance as a proactive effort to identify patient safety events.
Robert Di Giovanni
Global Project Safety Lead
Novartis
Robert is a medical doctor who worked in hospitals and then clinical development before joining Pharmacovigilance as global safety lead of multiple products. His experience includes both pre-market and post-market phases including medicinal products, medical devices and combination products.
Adam Price
Director of Product, Post-Market
Rimsys
Adam has more than 15 years of medical device industry experience as a quality assurance and regulatory affairs professional. Adam is currently focused on the development of strategies and solutions to establish and maintain compliance in today’s fast-paced regulatory environment to enable businesses to meet the demands of the global market.
Carlos Galamba
Vice President, IVD Intelligence & Innovation
RQM+
Carlos Galamba previously served as BSI’s first in-house clinician for IVDs. At RQM+, he works with the Intelligence & Innovation team, providing thought leadership and helping to drive technical quality for in vitro diagnostics.
Ashley Kelleher
Senior Medical Device Consultant for Medical Devices/IVDs
NSF
Ashley Kelleher has more than 14 years of professional experience in the medical device, pharmaceutical and certification industries. Her experience includes program management, project management and implementation of global, certification body and notified body accreditations to the ISO 13485, ISO 9001, ISO 15378 and ISO 14971 standards; GDP/GMP/GLP requirements; as well as MDSAP, EU 2017/745, MEDDEV 2.7/1 rev. 4 and relevant MDCG guidelines. Throughout her career, Ashley has developed several standardized interpretation trainings for ISO standards, state and federal regulations for external assessors and certification body personnel, that worked for the medical device, diagnostic and pharmaceutical sectors.
Ashley joined NSF in May 2022, as a Senior Consultant for Medical Devices/IVDs and is responsible for client engagements, consultation, implementation and optimization of quality management systems, submissions for technical file documentation, risk management, regulatory submissions and training. Ashley’s educational background is focused on Veterinary Science. She completed further training programs in order to broaden her expertise and holds lead auditor certifications for ISO 13485, GDP, MDSAP, EU-MDR, ISO 14971, ISO 9001 and ISO 15378.
Lana Feng, PhD
Co-Founder & CEO
HUMA.AI
Dr. Feng has over 20 years of experience in the biotech and pharmaceutical industries, mostly in precision medicine. Previously, she worked with Novartis Oncology Business Unit to establish international partnerships for their precision medicine programs. She joined Novartis through its acquisition of Genoptix. Dr. Feng built the BioPharma division at Genoptix. She grew the business from zero to $45M in five years by forging alliances with pharmaceutical companies and providing CDx development for targeted therapies.
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