Archives: Speakers

Shauna is a versatile QM/RA professional, with extensive experience in project management, supporting research and development, developing clinical evaluations and associated documentation, facilitating new product introduction, optimising manufacturing operations, obtaining market access, and leading post-market surveillance activities. A validation subject matter expert with 10 years of hands-on validation experience, decision-making and a Major in Process Validation.

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.

Stefan Meyer is co-founder and CTO of Implandata Ophthalmic Products GmbH. He has more than fifteen years of experience in development of novel medical products meeting regulatory standards and market acceptance criteria.

He was co-founder of Cranium Telemetrics GmbH, a medical technology company with innovative neuro-surgery products whose technology was acquired 4 year after foundation by a leading US medical device company. Thereafter he was responsible for technology transfer to this company. Stefan Meyer was instrumental in developing Implandata Ophthalmic Products GmbH’s technology platform and utilizing this platform for products within medical applications. He is author of multiple medical technology patents.

Jie is focused on clinical evidence acquisition-oriented clinical trial organizations and medical affairs management. He provides medical expertise and support throughout product life-cycle, including medical strategy and requirements, clinical evaluation plan and report, HHE, risk analysis and mitigation, and post-market activities. Jie participated in MDR uplift project at the process and product level.

Experienced in medical & regulatory affairs consulting, familiar with Infusion, Transfusion, and Enteral Nutrition supporting devices, Advanced Hemodynamic Monitoring, orthopedic and dental implants, surgical navigation system, balloon catheter and stent, microscope, lens, and wound closure and healing covers.

Heinrich Martens, VP Regulatory Affairs, hasmore than 15 years of experience working in Regulatory Affairs / Medical Devices. In his carrier, Heinrich Martens, was leading and being responsible for the various Regulatory Affairs projects – e.g. implementation of the Medical Device Regulation, leading and building up RA teams.

Leading an international team, across the globe, and being in contact with Authorities, Notified Bodies and Regulators – is one of his key topics, within his current role.

Yvonne Leguil has 30 years of experience in planning, allocation, production and logistics. She has been part of major transformations including AI introductions in companies like Esprit, Puma, Hugo Boss, Orsay and Beeline.

Sanja Becirovic is a former Merchandiser and Business Development Manager for companies like Mango, Jigsaw and ASOS. Focusing on helping brands and retailers find their optimal price and expansion strategies with over 10 years of experience in the fashion industry.

Iain Woodhouse is an innovator, strategist and remote sensing expert. He has been a Professor of Applied Earth Observation at Edinburgh University for over 20 years and specialises in research on the use of synthetic aperture radar (SAR) and LiDAR  for monitoring the forests of the world. This contributes to sustainable forest stewardship and sustainable (managed) forestry.

Prof. Woodhouse has been Chair of a the UK Space Agency Earth Observation Advisory Committee and a member of the Group on Earth Observations (GEO) Capacity Building Working Group.

As well as being an academic, Iain has been involved in setting up three startups in the energising Edinburgh innovation ecosystem. He is Co-founder of Earth Blox, which provides climate and nature analytics from satellite imagery to help businesses accelerate their sustainability transition. The software maps and analyses key metrics for biodiversity, water and carbon across forestry, agriculture, and financed and insured assets worldwide.

Iain believes that the key to his success is a good sense of strategy and an ability to draw together excellent teams who are able to excel in innovation. He has over 27 years of experience in academia and industry, 100+ publications, and advises UK government agencies on earth observation strategy.

Since 2020, Chris’s deep, hands-on experience with the OpenClinica suite of solutions has made him a key member of our team. He has over 20 years of experience in leadership roles across clinical research and data analytics organizations spanning public companies, startups, consulting firms and academia. Chris earned a bachelor of arts in computer science from Dartmouth College.