Keynote: Building Resilience: Transforming Operating Models & the Role of Technology Across Product Lifecycle
Hear perspectives on the future of Medtech including how to increase resilience across the organisation, the role of technology, and modernizing operating models for sustainability.
Donielle Johnson
Vice President, Regulatory Affairs Medical Devices
Bausch Health
Donielle Johnson is Vice President, Regulatory Affairs Medical Devices for Bausch Health. In this role, Donielle leads the creation of a global medical device organization that supports strategic priorities ensuring access to innovative technology and compliant maintenance of business. She partners closely with stakeholders across Medical Devices and represents Bausch Health in various internal and external forums with regulatory bodies, health authorities, and trade associations. Donielle leads a dedicated team who work collaboratively to ensure consistency in global medical device policy shaping activities. Prior to Bausch Health, Donielle was the Sr. Director of Regulatory Affairs for EMEA & Canada at Johnson & Johnson. Prior to Johnson & Johnson, Donielle held several global roles with major medical device companies including Philips, Abbott Vascular, and Medtronic. Leading teams through challenging premarket approvals; such as, PMAs, 510(k), Health Canada approvals, and MDD Design Dossier approvals. Additionally, Donielle has extensive experience in lifecycle management and leading major manufacturing site change projects, resulting in several millions of annual savings for the company. Her career has spanned several countries including the U.S, Japan, and the Netherlands where she has lived since 2014.
Sessions
Keynote: Building Resilience: Transforming Operating Models & the Role of Technology Across Product Lifecycle
Tuesday, 3 May
13:00 CET
Donielle Johnson
Vice President, Regulatory Affairs Medical Devices
Bausch Health
Dr. Bassil Akra
CEO
AKRA TEAM GmbH
Dr. Akra is CEO and Owner of AKRA TEAM GmbH, a consultancy company founded in 2021 to support the various stakeholders in the healthcare system achieving their target in a highly regulated business. He spent the last year consulting and supporting medical device, in-vitro diagnostic, and combination device companies preparing their strategy for the EU regulations MDR 2017/745 and IVDR 2017/746. Before that, he spent many years as a subject matter expert at the biggest notified body in Europe acting in the various roles and representing locally and globally the notified body association in various European discussion and guidance documents preparation. Dr. Akra was the Vice President of Strategic Business Development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has long experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products. Dr. Akra played an essential role during the implementation of the medical device regulation in Europe. He was also involved in drafting several European guidance documents (e.g. MEDDEV, MDCG, etc.) and International Standard. He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR), supporting their implementation towards achieving the relevant designation ensuring continuity of the healthcare system in the interest of the patient population.
Sessions
Keynote: Building Resilience: Transforming Operating Models & the Role of Technology Across Product Lifecycle
Tuesday, 3 May
13:00 CET
Dr. Bassil Akra
CEO
AKRA TEAM GmbH
John Brennan
VP Quality, Regulatory Affairs, & Government Affairs, EMEA
Medtronic
John joined Medtronic in September 2018 as Vice President, Regulatory Affairs & Quality EMEA. In May -19, he took on additional responsibility heading up Government Affairs EMEA.
John brings nearly 30 years' experience from the healthcare sector, most recently in Brussels's European healthcare innovation and legislation policies. John was Secretary General for the European biotech trade association, EuropaBio, and Director of Regulatory Affairs and Industrial policy for nearly ten years at the European health industry trade association MedTech Europe. He also spent five years in the Medical Devices Unit within the European Commission.
Before coming to Brussels, John worked in and managed the Irish Notified Body, NSAI, gaining extensive European and international experience in the design approval of high-risk devices and quality management systems. He sat on the working group which developed the international quality management systems standard for medical devices, ISO 13485. He began his career in the industry with five years' experience spanning the in vitro diagnostic, pharmaceutical and medical device industries.
John is a science graduate from Dublin, Ireland, with added post-graduate studies in quality control and environmental engineering.
Sessions
Keynote: Building Resilience: Transforming Operating Models & the Role of Technology Across Product Lifecycle
Tuesday, 3 May
13:00 CET
John Brennan
VP Quality, Regulatory Affairs, & Government Affairs, EMEA
Medtronic
13:45 — 14:30
CET
Illumina: Driving Speed to Market from its Clinical Center of Excellence (Clinical)
Illumina shares how their clinical center of excellence has improved global collaboration resulting in faster and higher quality study data delivery and speed to market
Matthew Purner
Sr. Director, Regulatory & Clinical Affairs
Illumina, Inc.
Matt has 20+ year of leadership experience across academic research, biopharmaceutical, and IVD industries. As Sr. Director, Clinical Affairs at Illumina he is focused on the success and growth of their Next Generation Sequencing division. He has extensive experience working with the Veeva Clinical Platform, having supported the implementation of both clinical operations and clinical data management solutions at Illumina.
Sessions
Illumina: Driving Speed to Market from its Clinical Center of Excellence (Clinical)
Tuesday, 3 May
13:45 CET
Matthew Purner
Sr. Director, Regulatory & Clinical Affairs
Illumina, Inc.
Kellie Hazell
Sr Manager, Clinical Affairs
Illumina
With eighteen years in clinical research, Kellie Hazell has supported, monitored and managed pulmonary devices, oncology pharma, and in vitro diagnostics studies. Kellie has been with Illumina for three years and manages Illumina's Veeva platform for the Medical organization, focusing on ClinOps and CDMS.
Sessions
Illumina: Driving Speed to Market from its Clinical Center of Excellence (Clinical)
Tuesday, 3 May
13:45 CET
Kellie Hazell
Sr Manager, Clinical Affairs
Illumina
SOPHiA Genetics: Addressing Hyper-Growth with a Digital, Data-Driven Approach (QA/RA)
SOPHiA Genetics shares how they're tackling the organisational challenges of hyper-growth alongside regulatory changes to IVDR with a digital approach. Hear how they're prioritizing process changes, ensuring successful implementation and adoption, and planning for the future.
Melissa Finocchio
Chief Regulatory Officer
SOPHiA GENETICS
Melissa is an experienced regulatory and quality professional with more than 20 years of experience in in-vitro diagnostics. Before joining SOPHiA Genetics as the Chief Regulatory Officer in May 2021, she worked for bioMérieux where she held various positions in product development, project management, complaint handling, labeling, and quality. Having lived and worked in multiple countries, she has experienced first-hand the challenges of cross-cultural communication and international management on a global scale and is passionate about the role of quality in facilitating efficient operations.
Sessions
SOPHiA Genetics: Addressing Hyper-Growth with a Digital, Data-Driven Approach (QA/RA)
Tuesday, 3 May
13:45 CET
Melissa Finocchio
Chief Regulatory Officer
SOPHiA GENETICS
Dr. Tom Petty
Head of Quality Systems & Knowledge Management
SOPHiA GENETICS
Tom is the head of Clinical and MedTech Knowledge Management and Quality Systems at SOPHiA GENETICS. He has more than 20 years of experience in academic, clinical, and industry settings leading Business Transformation, Quality Assurance, and Global Training initiatives. He has a diverse portfolio of scientific and IP achievements in Structural Biology, Data Science, Virus Genomics, and Cancer. He is a seasoned computational biologist with substantial training in molecular, clinical, and computer sciences.
Sessions
SOPHiA Genetics: Addressing Hyper-Growth with a Digital, Data-Driven Approach (QA/RA)
Tuesday, 3 May
13:45 CET
Dr. Tom Petty
Head of Quality Systems & Knowledge Management
SOPHiA GENETICS
14:30 — 15:15
CET
Terumo: Transforming Clinical Operations from Regional & Manual to Global Collaboration & Excellence (Clinical)
Learn how Terumo transformed from a regional, manual, and paper-based clinical operations model to one global, digital approach enabling global collaboration and clinical excellence across all studies.
Kazuhisa Senshu
Chief Clinical & Regulatory Affairs Officer
Terumo
Kazuhisa joined Terumo Corporation in 1987 as a research engineer and was involved in medical device development projects such as a drug-eluting stent, Nobori®/Ultimaster®. From 2009 to 2015, he worked in Terumo Europe, in Belgium as a clinical scientific manager to generate clinical evidence for the purpose of regulatory approval in EU and outside EU. In 2017, Kazuhisa assumed Chief clinical & regulatory affairs officer in Tokyo, Japan.
Sessions
Terumo: Transforming Clinical Operations from Regional & Manual to Global Collaboration & Excellence (Clinical)
Tuesday, 3 May
14:30 CET
Kazuhisa Senshu
Chief Clinical & Regulatory Affairs Officer
Terumo
EU IVDR 5 years in: Pulse of the Germany Industry and Journey Ahead (QA/RA)
Dr. Sascha Wettmarshausen
Head of Regulatory & Quality
VDGH - Verband der Diagnostica-Industrie e.V.
Passionate lobbyist and responsible for the entire area of Regulatory Affairs & Quality for the Association of the IVD Industry in Germany (VDGH). In addition to various co-chairmanships in the European association MedTech Europe (MTE), he is very well connected in German politics and authorities and the EU Parliament, the Council, and the EU Commission.
Dr. Sascha Wettmarshausen is also professionally involved in various advisory boards (Rili-BÄK - German Medical Association), NAMed (DIN), Entourage (management consultancy) and others from the heart.
Sessions
EU IVDR 5 years in: Pulse of the Germany Industry and Journey Ahead (QA/RA)
Tuesday, 3 May
14:30 CET
Dr. Sascha Wettmarshausen
Head of Regulatory & Quality
VDGH - Verband der Diagnostica-Industrie e.V.
15:15 — 15:45
CET
Networking & Refreshments Break
15:45 — 16:30
CET
ConvaTec: Accelerating Study Delivery & Improving Patient Experience (Clinical)
Learn how ConvaTec transformed clinical operations and data management to accelerate study execution and delivery to meet increased clinical evidence requirements and provide better patient engagement.
Julie Nicholson
Senior Manager, Clinical Projects
ConvaTec Limited
ConvaTec is a Medical Device company specialising in medical devices for wound care, continence care, critical care, ostomy care and infusion care. Julie is a member of ConvaTec's Medical and Clinical Affairs Group based in the UK and is responsible for all of the clinical studies conducted by ConvaTec involving human subjects.
Sessions
ConvaTec: Accelerating Study Delivery & Improving Patient Experience (Clinical)
Tuesday, 3 May
15:45 CET
Julie Nicholson
Senior Manager, Clinical Projects
ConvaTec Limited
Bracco: Omnichannel Best Practices to Ensure Compliance
Hear how Bracco has embarked on a company-wide digital transformation to gain sustainability and efficiency in it's omnichannel approach to promotional and scientific content creation, approval, management, and distribution.
Michele Vespasiani
Digital Transformation Manager
Bracco Imaging
With more than 20 years of experience in the healthcare arena, from pharma to medical devices (6 years) and surgery facility management, Michele put Digital Transformation as the pillar of his actions to increase profitability and productivity from a strategic and tactical standpoint. Michele specialises in CRM, ERP, and system integration via ETL platforms.
Sessions
Bracco: Omnichannel Best Practices to Ensure Compliance
Tuesday, 3 May
15:45 CET
Michele Vespasiani
Digital Transformation Manager
Bracco Imaging
16:30 — 17:15
CET
Closing Session: MDR and IVDR Impact on Europe's Innovation Capability
Erik Vollebregt
Partner
Axon Lawyers
Erik specialises in EU and national legal and regulatory issues relating to medical devices, IVDs, medicines and biotechnology, with a focus on legal and regulatory advice, contracts, regulatory litigation against competent authorities and M&A. Erik is the author of the acclaimed Medicadeviceslegal.com blog and The Enriched MDR and IVDR handbook.
Sessions
Closing Session: MDR and IVDR Impact on Europe's Innovation Capability
Tuesday, 3 May
16:30 CET
Erik Vollebregt
Partner
Axon Lawyers
17:15 — 18:30
CET
Networking & Cocktail Reception
Join your peers and the Veeva MedTech team for networking, refreshments, and cocktails. Immediately following is the MedTech Forum Welcome Reception - one floor down from this event.
18:00 — 21:00
CET
MedTech Forum Opening Reception & Dinner (Optional)
Join the MedTech Forum opening reception as a Veeva MedTech guest. This is complimentary even if you are not registered to attend the Forum event.