A Master of Pharmacy and DIA member since student days, I have had the opportunity to work in various fields of pharmaceutical and medical devices safety and regulatory affairs before settling in Clinical Trials regulatory environment. I have a strong interest in EU Clinical Trials Regulation and its impact on European countries on the outskirts of the EU, including Eastern Europe. I like to keep an eye on new technologies and their application in clinical trials. As a rare disease patient, I am genuinely committed to addressing unmet needs of this group of patients. J.R.R. Tolkien wrote “It's the job that's never started as takes longest to finish”, so I am always looking forward to embarking on new regulatory journeys.

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 the lead of the CTCG ethics advisory group. 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.

Dr. Elke Stahl, Clinical Trial Unit BfArM, Germany. Clinical Trials Senior Expert. CoChair of the Clinical Trial Facilitation Group (CTFG) till 2022. Involved in EMA’s EU CTIS groups as BfArM’s representative, National Contact Point for the CTR in Germany, representative in European Commissions CT working groups. Prior BfArM 10 years experiences as a pharmacokineticist at Bayer HealthCare AG, Germany, in early research up to candidate selection. PostDoc at Hoffmann-La Roche Inc and University of North Carolina (UNC). Ph.D. in pharmacology and licenced pharmacist.

Rose-Marie joined Bayer in July 2013 and is a Senior Manager in EU Regulatory Policy & Intelligence, with special responsibility for CTR implementation and Transparency within the Company. Rose-Marie came to Bayer with over 20 years EU regulatory experience in both the prescription and non-prescription healthcare sectors gained within a number of large research based Pharmaceutical Companies; as well as having worked as a Senior Regulatory Consultant in a small CRO. Rose-Marie has a BSc (1st class hons) in Chemistry and Biochemistry.

Currently working in Europe and International regulatory policy and strategy group in Pfizer. Been working for Pfizer since 1998. My main focus - lead a small team providing regulatory policy and strategy to Pfizer organisation particularly regulation of clinical trials. Previous employment includes SmithKline Beecham, Scrip and Cambridge Antibody Technology

Responsible for Pharmacovigilance activities in the EU and Balkans, as well as PV Intelligence and Operational activities within the International PV organization. As part of the Operational activities she holds responsibility for the PSMF. She previously served as Intelligence and Training expert in PV as part of the Quality Standards and Training Group in Bristol Myers Squibb and managed PV projects. Willemijn is a member of the EFPIA Pharmacovigilance Expert Working Group and the International Pharmacovigilance Group where she chairs the CIS and Balkan sub-teams. She started her career in Quintiles, followed by Aventis where she was involved in GCP activities.

Previously served as Senior Vice President and Managing Director for DIA Europe, Middle East, and Africa (EMEA) in addition to corporate international public affairs and as consultant for Amgen, Merck KGaA, and Biogen, working across market access, government affairs, public affairs, health policy, corporate communications, and patient advocacy to bring medicines to patients. Mr. Bols has held board positions for Europabio, the European Confederation of Pharmaceutical Entrepreneurs, and other associations, and chaired various regulatory and access working groups within the European Federation of Pharmaceutical Industries and Associations. Mr. Bols earned his post-graduate degree in European Law from the University of Amsterdam.

Judith Creba has many years experience in drug development, regulatory affairs and strategy at Novartis. She has worked in a range of therapeutic areas, including Oncology, Infectious Diseases, and Cardiovascular, before moving into EU Regulatory Policy where she has represented Novartis on a number of trade association committees. Judith is currently involved in clinical trials policy and is co-chair of the EFPIA Clinical Research Expert Group. She is also leading implementation of the new EU clinical trial regulation within Novartis.

Loes Markenstein LL.M is working as a legal professional in the field of health law and data protection law. During her time working at the Central Committee on Research involving Human Subjects (CCMO) she was involved in redrafting the template Subject Information Sheet to comply with GDPR. Presently she is working at the Dutch Data Protection Authority with a focus on the processing of personal data in the health care sector and in health research.

Sarra has worked more than 10 years in Genetics and in Gastroenterology with different positions at the University of Rome “Tor Vergata”. Also working for the Italian Medicine Agency (AIFA) since 2013 and obtained a permanent position in the Agency in 2018. Currently working as Preclinical and Clinical Assessor in the Pre-marketing department of the AIFA with various responsibilities as VHP coordinator, CTFG delegate and secretary. Bachelor’s degree in Molecular Biology, PhD in mucosal immunology, Master degree in Regulatory Affairs.

Fergus Sweeney is Head, Clinical Studies and Manufacturing Taskforce at the European Medicines Agency since March 2020, covering Clinical Studies (Clinical Trial Information System), Biological Health Threats and Vaccine Strategy and supports strategy development in manufacturing and personal data protection in health research on medicines. He joined the EMA Inspections Service in 1999, and became Head of Compliance and Inspections (2009) and Head of Division Inspections and Human Medicines Pharmacovigilance in 2013 (including Scientific Committee Services from 2016). He has a BA (Physiology 1979) a Dr de 3eme Cycle (cancer biology 1982), and PhD (Pharmacology 1986). Fergus worked in clinical research mainly in QA from 1982 to 1999.

Katelijne Anciaux obtained her PhD in Biochemistry at the University of Antwerp (1997). She worked for 12 years as pharmacokineticist in pharmaceutical industry (late development). She joined the Clinical Trial College at the Federal Public Service of Health as a quality expert in 2017. She coordinated a working group that prepared a new Belgian ICF template for adult patient clinical trials. In the CT-College she is responsible for the harmonization and quality assurance of the ethics committees.

physician- patologist, paediatrician+oncologist, since 2003 till now clinical assessor of CTs at the NCA

Jaspreet is an Associate at Baker McKenzie in London, and focuses on healthcare and technology. She advises on commercial and regulatory issues in the healthcare space, including commercial uses of patient data, licensing of medical datasets, medical research, health apps, applied AI, contracting for goods and services, and supply chain issues. Jaspreet has a particular interest in the intersection between tech and healthcare.

Outi Konttinen has served as an executive secretary of the national committee since 2001. She is Master of Social Sciences, political science and public health as her main subjects. Outi has been appointed to represent Finland and/or Finnish RECs in the following EU institutions and other EU-level bodies: European Commissions Clinical Trials Expert Group; European Network on Research Ethics Committees (EUREC); EMA CTIS expert group and Union database meeting with Member States, EMA.

Stéphanie Kromar joined the European Organisation For Research And Treatment Of Cancer (EORTC) in 2013. Since September 2022, she is the Head of the Regulatory Affairs department. She has experience in the preparation, submission, and follow-up of Clinical Trials Applications from the development until the end of the trial, on complex trial designs and she provides regulatory advice. She has an in-depth knowledge of the CT Regulation, was involved in the CTIS project almost since the beginning and she also took part to the review of the CTIS training material.

Pierre-Frédéric Omnes recently joined Transperfect Life Sciences & has over 20 years of experience in global CROs and Pharma Companies as Regulatory Affairs consultant, overseeing numerous multinational clinical trial applications globally. He is a subject matter expert on SSU and Regulatory Operations in global clinical trials as well as on the EU CTR 536/2014 for corporate readiness, implementation, EU Portal, transparency. Pierre is part of the EMA-led initiative developing the CTIS as Lead Product Owner representing the Industry & Academia, continuing his engagement of several years in User Acceptance Testings, Workshops and Analysis& Design sessions related to the system development.

Sini is working as Regulatory, Drug Development and Manufacturing Director at EFPIA since 2014 and leads the team since 2018. She is responsible for various regulatory policy and advocacy activities in relation to regulatory science and regulatory strategy. She has previously worked over 5 years at AZ R&D Global Regulatory Affairs in Sweden and 3 years as Executive Director of Finnish Pharmacists' Society. She is currently doing a part-time PhD for professionals programme at the University of Utrecht and WHO collaboration centre for pharmaceutical policy and regulation. She is a Board member of Industrial Pharmacy Section in International Federation for Pharmacists and Pharmaceutical Sciences since 2010.