INTERNATIONAL SCOPE

About Dr. Zeinab Darwich

Passionate about science, especially biology and the medical field, Zeinab worked for about 5 years after her PhD for public laboratories and then for Sanofi.
She obtained a PhD in biophysics and cell biology at the University of Strasbourg in 2012. For two years after, she worked as a post-doc at INRA in Dijon, followed by three years at Sanofi R&D as a research scientist, then as a biomarker manager for clinical trials until 2019.
In November 2020, she started to follow the DU FIEC (training of investigators in clinical trials) at the University of Paris to deepen her knowledge on clinical trials and advance in the medical field.
Throughout her professional experiences, she has developed a wide range of skills from writing of articles, protocols, reports, book chapters to technical skills in biophysics, cell biology, and immunohistochemistry. These experiences enabled her to develop soft skills such as team spirit, multitasking autonomy and project management.

About Dr. Dimithu Perrera

With an MSc in Molecular Medicine from the University of Essex and a BSc in Bioscience from Canterbury Christ Church University in the UK, Don is an experienced medical writer with a proven track record in a variety of therapeutic areas, including respiratory, gastroenterology, cancer, immunoassays and all classes of medical devices. 
He has 5 years of experience in medical writing, including CERs and PERs, as well as 4 years in regulatory affairs.
Clinical studies are also an important part of his background. Don has conducted clinical studies around the world, working closely with KOLs, and has created and led a clinical board.

About Valérie Longin

Valérie holds a Master’s degree in Biotechnology R&D from the Pierre and Marie Curie University and started her career at Roche in pharmacovigilance.
She then headed to the field of clinical research as a CRA/TEC at URC Necker Cochin, then joined IQVIA as CRA for interventional studies and later as Lead CRA for real life studies in different therapeutic areas.

With nearly 10 years of experience in healthcare, Valérie brings to Eclevar her expertise in clinical research and her excellent relationship with the various stakeholders.

About Pr. Luc Téot

Pr. Luc Téot is the head of the Burns Unit and Wound Healing Unit of the Montpellier University Hospital in France. He is author of over 100 publications and wrote several books and book chapters.

He is an editorial board member of 8 journals and former president of the World Union of Wound Healing Societies and the European Tissue Repair Society.

He teaches as professor at the universities of Montpellier, Nantes, Limoges, Antilles and La Réunion. His passion for wound healing and scarring has encouraged him to become organiser of international conferences like Scar Club, Conférence de Plaies et Cicatrisation and the International Workshops on Wound Technology. Prof. Téot is qualified in General, Orthopaedic and Plastic surgery.

About Dr. Max Woitok

Dr. Max Woitok holds a degree in biology from the RWTH Aachen University and has a 10-year experience.
After his bachelor’s degree, he decided to focus on the biomedical research disciplines and proceeded with the master’s program in Biomedical Engineering at the RWTH Aachen University. The program was an interdisciplinary course of studies involving the interaction between the Natural Sciences, Medicine, and Engineering, providing him with theoretical and practical knowledge and methodic details in these subjects.
During the period of his master thesis, he was grateful to be accepted to work in the biomedical field at the Center for Biomedical Research, The Queen’s Medical Center in Honolulu, Hawai’i, U.S.A. After graduation, he took the opportunity to deepen his knowledge of biomedical engineering in the field of urology at the Uniklinik RWTH Aachen.
Next, he pursued a doctoral degree in the field of hepatocellular carcinoma at the clinic for Gastroenterology, Metabolic Diseases, and Internal Intensive Care Medicine, Uniklinik RWTH Aachen.
During his time as a Postdoc, he decided not to proceed with a scientific research career but to take the opportunity to work for a company located in Aachen, specialized in regulatory affairs for the medical device industry. This experience enabled him to gain deep insights in medical writing of clinical evaluations and Post-Market Clinical Follow-up (PMCF) studies under the new European Medical Device Regulation (MDR).

About Pr. Yann Gouëffic

Yann GOUËFFIC is the Head of Vascular Surgery Department at the Nantes CHU, the president of clinical trials department at Hospital of Saint Joseph.
He also is board member of the Meet congress as well as the head of Treasure of the French society of vascular and endovascular surgery.

He recently joined ECLEVAR as a scientific board member to help establish quality reimbursement routs (clinical and medico-economics data) is crucial to obtain the reimbursement and provide expertise in setting up clinical trials in France.

About Pr. Yann Gouëffic

Yann GOUËFFIC is the Head of Vascular Surgery Department at the Nantes CHU, the president of clinical trials department at Hospital of Saint Joseph.
He also is board member of the Meet congress as well as the head of Treasure of the French society of vascular and endovascular surgery.

He recently joined ECLEVAR as a scientific board member to help establish quality reimbursement routs (clinical and medico-economics data) is crucial to obtain the reimbursement and provide expertise in setting up clinical trials in France.

About Pr. Luc Téot

Pr. Luc Téot is the head of the Burns Unit and Wound Healing Unit of the Montpellier University Hospital in France. He is author of over 100 publications and wrote several books and book chapters.

He is an editorial board member of 8 journals and former president of the World Union of Wound Healing Societies and the European Tissue Repair Society.

He teaches as professor at the universities of Montpellier, Nantes, Limoges, Antilles and La Réunion. His passion for wound healing and scarring has encouraged him to become organiser of international conferences like Scar Club, Conférence de Plaies et Cicatrisation and the International Workshops on Wound Technology. Prof. Téot is qualified in General, Orthopaedic and Plastic surgery.

About Dr. Mikaela Dimitriu

Camilla Fleetcroft

Camilla has a wealth of experience in both clinical and regulatory spaces. Since qualifying as a doctor, she has been working at the MHRA for over 8 years, with a period of time spent at SGS during this time as well. In her current role, she has been responsible for leading the consultation and development of the UK regulations for medical devices following Brexit, and is involved with policy makers, regularly interacting with ministers and decision makers.

Val Theisz

Val Theisz is a regulatory affairs professional with over 15 years of experience in medical devices of all risk classes, including life-sustaining, high-risk active implantables, and software as medical devices (SaMD) using Artificial Intelligence (AI) algorithms. Val holds Regulatory Affairs Certification credentials for EU and US regulations (RAC EU, RAC US) from the US-based Regulatory Affairs Professionals Society (RAPS and is one of the two RAPS Fellows based in Australia. She authored the book ‘Medical Device Regulatory Practices: An International Perspective’ available through CRC Press. Val’s experience within the field covers the entire product lifecycle: regulatory strategy; verification and validation (V&V); testing and compliance to international standards; clinical trials for high-risk innovative medical devices; submissions and pre-market approvals in established markets (CE Marking, FDA 510(k) and PMA, TGA registration, Health Canada licences); and post-market ongoing compliance. Her experience spans the major markets of the EU, USA, Australia and Canada. Val has also been the Director of Regulatory & Clinical Affairs, Code of Practice with the Medical Technology Association of Australia, leading industry advocacy initiatives with the Therapeutic Goods Administration and the Australian Department of Health.

Edmund White

A Medical Technology and Life Sciences products leader with over 20 years of progressive global, sales, marketing and operations experience and proven ability to consistently outperform expectations. Analyze markets, identify opportunities and create and implement strategies to achieve marketplace dominance. Develop relationships with key opinion leaders to influence potential customer perceptions. Entrepreneurial mindset with collaborative approach. Manage cross-functional teams and relationships with partners and affiliates worldwide