Speakers EUCROF25

Monique Al is currently special advisor at the Central Committee on Research Involving Human Subjects (CCMO) in The Netherlands. Since May 2023 she is the vice-chair of the Clinical Trial Coordination Group. She is also co-chair of MedtEthicsEU, a group of national representatives of Medical Research Ethics Committees in EU/EEA launched in February 2024. Her background is Clinical Nutrition with a PhD in Human Biology. She has worked for several nutritional and pharmaceutical companies in the field of clinical research before she started in 2001 as a scientific staff member at the CCMO.

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Family and Community Medicine Resident, Region 1 Medical Center;
Graduate of Doctor of Medicine from Saint Louis University
 I am a dedicated physician specializing in Family and Community Medicine. With extensive experience in providing comprehensive healthcare, Dr. Tumaliuan is committed to improving patient outcomes through evidence-based practices.   

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Experience in
– M&A transactions in healthcare & life sciences;
– litigation in the fields of copyright, design rights, unfair competion, misleading advertising, comparative advertising and trademarks;
– advice on European law aspects of marketing law and CE marking of products
– advice on regulatory aspects of medicinal products and medical technology;
– drafting and negotiation of technology licences and R&D cooperation agreements;
– experience in application of competition law to IP licensing and competition law aspects of technology pools;
– experience as expert witness in international litigation on matters of EU New Approach (CE) legislation (Medical Devices, EMC and Low Voltage Directives)

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Based on working experience in government, industry and healthcare, I’ve acquired a broad overview of the complex playing field of market access of medical devices, combination products, IVDs and pharmaceuticals. In combination with detailed knowledge of and experience with the interpretation and implementation of the regulatory systems for these medical products, I am able to provide effective solutions and strategic input to a broad range of regulatory topics.

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Nicolas Thevenet is Director of Strategic and International Development at Euraxi Pharma with over 25years experience in clinical trials (rare disease, metabolic disorders, neurology, cardiology…).
Experienced in the pharmaceutical industry (1997 to 2002) and in global CRO as Sr Project Manager leading world-wide programs (until MAA), Nicolas is engaged in Decentralized Clinical Trials with the implementation of Euraxi affiliates in EU (France, Belgium, Netherlands, Germany, Italy and Spain) to deliver full-service home nursing activities with Nurses Country Managers…

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Dr. Manan Trivedi is an accomplished clinical and regulatory project management professional with over 14 years of experience in the pharmaceutical industry. He excels in delivering high-quality data in compliance with ICH-GCP, Client SOPs, and protocol requirements across Phase I to III clinical trials. Currently serving as the EU CTR Project Lead at UCB Biopharma, he oversees the end-to-end EU Clinical Trial Regulation processes. Previously, he focused on the design and implementation of EU CTR processes as Senior Manager at UCB Biopharma and held significant roles at GSK Vaccines, Freyr Regulatory Solutions, ICON Clinical Research, Syneos Health, and CARE Worldwide. Dr. Manan holds an Executive MBA, a PhD in Clinical Research, an MSc in Clinical Research, and a B.Pharmacy. He also boasts certifications such as Lean Six Sigma Black Belt and Accredited Project Manager (™). Renowned for his analytical skills, leadership, and dedication to quality, Dr. Manan is committed to continuous improvement in clinical operations and regulatory affairs.

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14 years of extensive experience in clinical research as Investigator and Site Director, working in international settings. Expert in patient recruitment.

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Kevin has 5 years of experience in industry, research, and medical environments. In these fields, he has been developing innovative projects in medical software technology and AI. He is a Biomedical Engineer by training and holds an MSc in Artificial Intelligence from the University of Essex in the UK. He is committed to contributing to the development of gold-standard techniques for real-world data collection from sensors, digital biomarker discovery, preventive medicine, and AI applications in healthcare.

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Experienced and dependable clinical research professional with a proven track record of over 5 years supporting drug and medical device trials in diverse therapeutic areas, including cardiac rhythm management, oncology, and ophthalmology.

Recently, I joined Nestle in March 2022 as a Clinical Project Manager, overseeing and managing clinical trials focused on nutrition. In this role, I am responsible for designing and executing clinical trials to evaluate the safety and efficacy of nutritional products.

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20 years of experience in medical & pharmaceutical information. Expert in databases and healthcare internet platforms. Successfully built leading drug information and media channels.

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