Kemine Hale

Associate Director, Global Regulatory Affairs

Novocure GmbH

Kemine Hale has over eighteen years experience as a medical device professional and entrepreneur. In the fields of orthopedic and active devices, Kemine has an impressive track record in diverse areas of Global Regulatory Affairs, Quality Assurance, Clinical Evaluation and Post Market Surveillance.

Kemine’s experience was honed in large corporations as well as start-ups.
Kemine is presently heading Novocure’s regulatory team focused on global market product approvals and compliance.

Kemine holds the Regulatory Affairs Certification and has a Masters in Business Administration, in addition to a BSc degree in Accounting with Law from the London School of Economics and a BSc degree in Management Studies from the University of the West Indies.

Gero Viola

Coordinator Regulatory Affairs

TÜV Rheinland AG

Gero Viola

Laure-Anne Thieren

Sr Quality Manager

Johnson & Johnson

Laure-Anne Thieren is a senior Quality and Compliance manager at Johnson & Johnson with comprehensive knowledge of the Quality System, vigilance system and safety management. Within the J&J Quality and Compliance organization, she is a key contributor to the PMS aspects of the EU MDR implementation project for the J&J Medical Device group. She is also co-chairing the MedTech Europe PMS working group and contributes directly to the European Commission MDCG for PMS and Vigilance activities, via different working groups such as the PSUR guidance task force.
Laure-Anne joined J&J over 15 years ago where she held several functions in the Quality organization. Laure-Anne is based in Belgium. She holds a bachelor’s degree in nursing with Health Education training.

Pedro Mendes

Global Technical Steward Devices

Novartis AG

Pedro Mendes PhD in Mechanical engineer, with over 20 years of experience in Analytics, Technology, Development and Manufacturing from the medical devices and pharma industry with primary focus on Combination Products.
In the past was responsible for putting in place the technical file of diverse medical devices and later involved in the process of updating the technical file to comply with the MDR. More recently was also in the process to implement the MDR on the devices that he is managing. He is also maintaining the Technical file up to date and responsible to assure the life cycle event associated with medical devices and MDR requirements.

Sean O’Callaghan

Certification and Inspection Officer

National Standards Authority of Ireland (NSAI)

Sean O’Callaghan is a certification and inspection officer with the NSAI performing site audits and offsite review of technical documentation. He is a member of the NSAI IVDR designation team.

Carine Cochereau

Vice President Regulatory Affairs International

Integra LifeSciences

Carine Cochereau holds a Pharmacist PHD and a MBA in Industry management. Further to 3 years of pharmaceutical and clinical activities in hospitals located in Paris, Carine started her professional career in medical device industries within Johnson & Johnson for a period of 12 years followed by 2 years within Cardinal Health and Biom’up playing different roles in Quality, Regulatory and Clinical affairs activities. Since October of 2019, Carine has been part of Integra LifeSciences as VP International Regulatory Affairs.

Since 2014, Carine has been chairing the Clinical Investigation taskforce in Medtech Europe and an active member of different groups such as the MDR, Eudamed.

Bijan Elahi

Technical Fellow and Corporate Advisor

Medtronic

Bijan Elahi has worked in risk management for medical devices for over 28 years at the largest medical device companies in the world, as well as small startups. He is a Technical Fellow, and the Medtronic corporate Advisor on safety risk management of medical devices. Bijan is a lecturer at Drexel University (Philadelphia, USA) and at Eindhoven University of Technology (Netherlands), where he teaches risk management to doctoral students in engineering. He is the founder of MedTech Safety, Inc., an education and advisory company and has educated over 5,000 individuals with outstanding results. Mr. Elahi is a contributor to the standard: ISO 14971, and is the author of the international best-selling book: Safety Risk Management for Medical Devices, published by Elsevier publishing.

Xiaoling (Sharlene) Dai

Sr. Principal Toxicologist

Abbott Laboratories

Xiaoling (Sharlene) Dai Sr. Principal Toxicologist at Abbott, is a technical leader in toxicological risk assessment and biological safety evaluation of medical devices to support global regulatory submissions. Prior to joining Abbott, Dr. Dai is the Distinguished Toxicologist/Technical Fellow at Medtronic plc, responsible for the biological safety evaluation and toxicology risk assessment through the life cycle of a wide variety of medical devices and applications, especially Class III implantable devices and drug device combination products. She is an international expert/delegate of the ISO 10993/TC 194 Working Groups. Dr. Dai holds BE in Biomedical Engineering, MD, and PhD in Neuroscience, and DABT and RAC certificates.

Mike Wallenstein

Global Head MDR Implementation, External Engagement & Compliance

Novartis Pharma AG

Mike Wallenstein holds the position as Global Head Novartis MDR Implementation, External Engagement & Compliance at Novartis Pharma AG Drug Device Combination Product Compliance since April 2019. In this role, Mike oversees all activities related to the EU MDR implementation for Medical Devices & Combination Products at Novartis globally.
Prior to this position Mike was functioning as Executive Director QA to oversee all compliance activities related to Medical Devices & Combination Products at Novartis globally.
Mike is member of several US and EU Expert Committees and Interest Groups on Combination Products.
Mike joined Novartis in 2010 as Global Auditor in Group Compliance and Audit. He has over 25 years of experience in QA, R&D, and Manufacturing within the Medical Devices & Pharmaceutical Industry.
Before joining Novartis, he was Head Global Audit Systems at Gambro Renal Care (today Baxter) and European Head Quality Systems & Audits at 3M.
He studied Chemical Engineering and Plastic Technologies, in Münster, Germany.

Christine Lynn Lanning

Distinguished Scientist

Merck Sharp & Dohme (MSD)

Dr. Christine Lynn Lanning is a Distinguished Scientist at MSD where she oversees the biocompatibility of the medical device/medical device combination product portfolio. She has a PhD from Duke University in Pharmacology/Toxicology and has been at MSD over 20 years with expertise in nonclinical drug and device development. Her previous roles include: Toxicologist/Study Director overseeing the conduct of toxicity studies from single dose to 2 years in duration; Compound Leader responsible for the compound’s nonclinical toxicology development program; Regulatory Affairs Liaison interacting with Health Authorities regarding development programs; and the Head of Toxicological Sciences where she managed the entire portfolio of toxicology studies. She has authored over 200 scientific reports and over 50 regulatory submissions.