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NAMSA

RAPS Euro Regulatory Convergence 2020

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Date/Time

Date(s) - October 26, 2020 - October 30, 2020 All Day

NAMSA invites you to join us online for the RAPS Euro Regulatory Convergence Conference on 26-30 October 2020. Come together with other European regulatory affairs professionals to discuss pressing regulatory topics and share best practices within the medical device industry.

This year, the regulatory community will converge online to allow attendees to experience the RAPS Convergence live online from the safety and comfort of their homes. With this new online format, any sessions you are unable to attend live can be viewed on-demand at your convenience.

Join NAMSA for our educational sessions listed below and visit us at our virtual booth at Booth #2.

Complimentary 30-minute consultations with NAMSA’s regulatory experts will also be available through virtual chats and phone calls. We welcome the opportunity to discuss with you the most cost-effective regulatory pathway to market based on your unique product development requirements.

Educational Sessions

Tuesday, 27 October | 8:30-9:30 AM CEST

Combination Products

Speaker: Jane Arnold-Round, MSc, B.Eng mTopra; Principal Regulatory Consultant, NAMSA

Tuesday, 27 October | 11:15 AM-12:15 PM CEST

MDR Technical Documentation for Legacy Products: Practical Tips and Tricks!

Speaker: Jane Arnold-Round, MSc, B.Eng mTopra; Principal Regulatory Consultant, NAMSA

Tuesday, 27 October | 1:30-2:30 PM CEST

Challenges and Understanding of the Periodic Safety Update Report (PSUR)

Lead by: Christine Quinton; Regulatory Quality Consultant, NAMSA

Tuesday, 27 October | 2:45-3:45 PM CEST

Working with FDA: Factors for Successful Approval

Lead by: Jason Krzeszak, MSE, MBA; Principal Product Development Strategist, NAMSA

Wednesday, 28 October | 8:30-9:30 AM CEST

Creating and Implementing Effective Post-market Clinical Follow-up Under the EU Medical Devices Regulation

Lead by: Adrian Keene, BSc (Hons); Director EMEA, Consulting Services, NAMSA

Wednesday, 28 October | 11:15-11:45 AM CEST

Impact of Notified Body Representative Technical Documentation Sampling - It Affects Your MDR Compliance Workload

Lead by: Matt Royle, PhD; Principal Regulatory Consultant, NAMSA

Wednesday, 28 October | 3:00-4:00 PM CEST

Risk Management - Focal Point for Regulatory and Legal Purposes

Speaker: Richard Bassett, LLM, MSc, BSc; Medical Writer, NAMSA

Speaker

Jason Krzeszak

Principal Product Development Strategist

Jason Krzeszak has 15 years of experience in product development of medical devices and joined NAMSA in 2018. Jason has led activities focusing on preclinical and clinical research of devices through the feasibility, premarket and post-market phases. Notably, Jason has held leadership positions within clinical affairs for both large and start-up companies, which also included cross-functional leadership responsibilities. He has clinical experience in vascular (cardiac, aortic and peripheral vascular), cervical spine and urinary stones, in addition to numerous applications of medical technology in the preclinical environment.

Jane Arnold-Round

Principal Regulatory Consultant

Jane Arnold-Round has over 25 years of experience in the medical device industry, working with a broad range of medical device technologies and organizations from start-ups to multinationals. She worked as a Notified Body reviewer for over 15 years at BSI as a Medical Device Product Specialist with particular responsibility in the wound-care sector. Prior to joining NAMSA in 2018, she was a Regulatory Consultant for 14 years. Jane’s current focus involves complex submissions for high-risk devices, including development of regulatory and clinical strategies, design dossier and technical file compilations, device-drug consultations, clinical evaluations and regulatory due diligence.

Christine Quinton

Regulatory and Quality Consultant

With a Master Degree in materials, Christine began her career in a start-up company in Germany as Quality Manager, with a focus on the quality management system and design dossier. Shortly following her work in the start-up, she worked as an Auditor for the Notified Body TÜV Rheinland and then the French Notified Body G-MED where she focused on the review of design dossiers and technical files for Breast Implants and Cardiovascular devices.

Before joining NAMSA, Christine worked as Process Manager for the assessment of EC-type and EC-Design Dossier, where she was responsible for writing guidance documents, training Products Specialists and participating in all inspections and joints assessment inspections according to MDD and MDR.

Adrian Keene, BSc (Hons)

Director EMEA, Consulting Services

With 26 years of experience in the medical device industry, Adrian’s knowledge of new product development combined with EU regulatory requirements enables him to provide a balanced interpretation of the needs and expectations of both competent authorities and manufacturers. His current responsibilities at NAMSA involve regulatory, quality, biological evaluation and medical writing—working with a broad range of devices including drug-device combination products.

Prior to working at NAMSA, Adrian was Head of Notified Body for the UK Notified Body SGS. Before working with the notified body, he was Global Clinical Affairs and Regulatory Manager for Medical Devices, with responsibility for conformity assessment activities of high risk (class III) devices under the Medical Device Directive (MDD).

Matt Royle, PhD

Principal Regulatory Consultant

Matt has over 15 years of experience in research, product development and regulatory affairs—including medical device start-ups, medium-sized and multinationals. He worked as a Notified Body Product Specialist for a number of years, specializing in conformity assessment of implantable class III and IIb orthopaedic joint replacement and sports medicine, spinal and bone grafting devices.

Richard Bassett, LLM, MSc, BSc

Medical Writer

Richard’s experience spans the full scope of medical device and IVD development, manufacturing and registration. He has extensive experience in auditing and consultancy, guiding numerous companies to CE marks as well as ISO 13485:2016 and MDSAP certification. Richard has held several cross-functional roles including Notified Body Auditor, Quality and Regulatory Lead and Research Assistant in clinical trials. He currently acts as a visiting lecturer to Cambridge University. Richard holds a BSc in Biomedical Science, an MSc in Structural Molecular Biology and an LLM in Medical Law, where his final thesis focused on medical device regulations and product liability law.