Alper has over 27 years of experience as a specialist qualitative researcher. Following his Master’s degree in Sociology of Education, his career began as a Social Policy Researcher working at the National Centre for Social Research, TNS-BMRB, and a decade as a freelance qualitative researcher, and then moving across to the medical devices space over 12 years ago.

Alper’s skilful moderation, project design and market insights have facilitated some of the top medical device manufacturers to better understand how to design, develop and market their medical products and devices, with users’ needs prioritised at every step. His expertise span across the entire product development lifecycle, form early stage exploratory and unmet needs research through to post-market insight, conducting research globally.
 

Arabe Ahmed is a Medicinal Expert in drug–device combination products at BSI, where his role is to provide specialist pharmaceutical affairs, regulatory and strategic support to medical devices and pharmaceutical companies. Prior to joining BSI, Arabe worked for more than 10 years for GSK and Novartis in the UK, and Germany respectively in various pharmaceutical development roles. He holds a doctorate degree in drug delivery research from Julius Maximilian University of Würzburg, Germany, and masters degree in Pharmaceutical Technology form King's College London. In addition, Arabe is a UK registered pharmacist and member of the Royal Pharmaceutical Society of Great Britain.

Blake Green is a Regulatory Affairs Senior Manager with Amgen’s Global Medical Devices Regulatory team. Based in Cambridge UK. Blake is a Devices Regulatory lead for medicinal product/medical device combination products and co-packaged medical devices in the biopharmaceutical sector. Prior to joining Amgen, Blake had significant international experience securing multi-national market clearance for manufacturers of medical devices, medical device/medicinal product combinations, medical software, personal protective equipment, and biocides, located throughout the United States of America, European Union, North Africa, Middle East, Far East, Turkey, Israel, Australia, Canada, and Peoples Republic of China.

Caroline is a highly experienced regulatory affairs leader, having held senior roles within the medical device industry. Caroline holds an MSc in Medical Engineering from Imperial College, London. At Victrex, Caroline is Head of Regulatory Affairs and Product Stewardship and leads a team of regulatory experts across Europe, USA and Asia. She works alongside medical device and pharmaceutical companies to navigate regulatory pathways to bring new and innovative medical devices incorporating PEEK to market.

Cedric Gysel is a Healthcare Solutions Manager for Johnson & Johnson Design, driving human-centered solutions for patients and customers and leading key innovation projects for device & packaging sustainability as we all product end of life programs across the pharmaceutical and medical device sectors of Johnson & Johnson. He has more than 15 years of experience with the development and design of devices and combination products. He holds a bachelor’s in pharmaceutical technology from the University of Basel and a master’s in medical device technology from the University of Applied Science.

Dr. Fatima Bennai-Sanfourche is working currently as Senior Director of QA&RA Compliance for Medical Devices, Combinations Products, and eHealth at Bayer AG.
Previously she worked in the medical affairs and Pharmacovigilance department at Bayer as Director, Medical Device Safety Global Pharmacovigilance/Medical device Safety officer.
She has more than 15 years of experience in the quality management and Regulatory Affairs of medical devices field, and over 20 years of supervisory and leadership experience including hiring, training and performance evaluation.
She studied Biology with a focus on Biochemistry, Immunology and Pharmacology, and did her PhD in Pharmacology and Pharmacochemistry in Strasbourg in France. She started her professional life with more university-oriented areas doing research and development in France, Sweden and Germany with a focus on cerebrovascular diseases, such as stroke, regulation of hypertension and development of immunoassays.
In her current position by Bayer AG her focus is ensuring the regulatory compliance as well as high product quality of medical device, combination products and eHealth components of the Pharmaceuticals portfolio.
She is also responsible for Ensuring compliant use of medical devices and medical software tools in the context of clinical investigations and clinical trials, incl. accordance with medical device Good Clinical Practice (GCP).
She is also leading the project of the implementation of euMDR for PH-Bayer AG.
She was nominated in 2019 by the European Commission as EFPIA observer for the PMSV (Post-Market Surveillance and Vigilance) subgroup (GROW.D4) responsible for the implementation of these process according the medical Device regulation. The period of nomination is of five years starting on 01 March 2019.
 

Jonny is a Chartered Mechanical Engineer with broad consultancy experience leading projects to address technical challenges in medical, industrial and consumer goods industries. He focuses on the underlying physics behind the product, paired with the manufacturing experience to bring ideas out from the initial concept to mass produced, cost-effective and robust solutions.

With his ability to tackle challenging technical issues, Jonny has gained experience in evaluating novel product concepts requiring integration of mechanical, fluidic and electrical systems. Jonny enjoys drawing on this experience to add value while leading product development projects and troubleshooting technical issues with a scientific mindset.
 

By education biomedical engineer with a Master degree in business administration. Julia gained experience in development, regulatory approval of combination devices and ATMP products. She was further involved in the development of standards for ATMP products. Currently Julia Frese is heading the division of Medical and Health Services at TÜV SÜD Japan and is responsible for the development of article 117 service within the organisation. She is further co-chair of the Team NB working group for article 117.

Originally training as a pharmaceutical scientist, Louise has over 14 years’ experience in drug delivery & medical devices with a focus on device technical management and regulatory strategy for EU & FDA submissions.
Louise joined GSK in May 2020 and leads the Device team within CMC Regulatory with responsibility for global regulatory and advocacy strategy (Devices) across the GSK portfolio.
With a solid background in inhalation and parenteral ‘combination products’ from concept to market through previous experience working at Pfizer, Oval Medical Technologies, and Cambridge Design Partnership, among others, Louise has a proven track record in supporting successful device submissions for different device types and markets.
 

Mark is responsible for the Product & Health Solutions within Digital Health at TEVA Pharmaceuticals. Over ten years with TEVA and prior to that sixteen with AstraZeneca. Mark has held various positions including R&D Project Leader, VP Sales & Marketing, Strategic Planning & Business Development, and Global Brand Lead. Graduated in Aeronautical Sciences and completed his MBA at Durham University, UK. During his career he has led technology & especially inhaler development teams through engineering, CMC characterisation, clinical evidence generation, registration within US, EU and International Markets and ultimately to successful global launch. Total Brand Leadership value >$2.5bn. Mark has numerous patents granted and pending in electronic communications, sports technologies, inhaled pharmaceutical development, and respiratory physiological function & predictive AI. Mark is the inventor of Digihaler®, the first FDA approved digital inhaler with built-in sensors.

Thomas is the Senior Director of Regulatory Affairs for Devices at Novo Nordisk and is responsible for devices and combination products.
He has extensive experience with regulating medical devices in Denmark and Europe, and he comfortably balances between business aims and regulatory demands.
As a former Director of Medical Devices in the Danish Medicines Agency and an MDCG member, he has worked with the public sector, MedTech-Industry and Patient-organisations to secure patient safety.
Thomas has been elected Chair of the Competent Authorities for Medical Devices (CAMD). And has experience in national and international arenas—Europe with the EU commission, EMA, Notified Bodies, Authorities, and patient organisations.
Thomas holds a master’s degree in political science from the University of Copenhagen. He has undertaken several courses and continuing education in project management and leadership and has several years of practical management experience.
 

Tiffany has been in the pharmaceutical industry for almost 9 years developing medical devices end to end, primarily in the combination product space. She started her career at Lilly after finishing her studies in Psychology in 2014. While working at Lilly she obtained her masters in human-computer interaction. 5 years ago she jumped across the pond to work at Boehringer Ingelheim (BI). For the last 3.5 years she has been working as a Principal HF engineer for Roche in Basel.

Yann is an experienced commercial leader, with a long history in the medical device industry. In his current role at Victrex plc, Yann is responsible for collaborating with a range of stakeholders across the medical device industry, from device engineers to innovation leaders involved in bringing the next generation of implantable and pharmaceutical devices to market. His specialist area is high performance PEEK polymers, and he works with several high-profile device manufacturers and design houses on material selection to optimise device components with PEEK polymers.