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.

MD specialist in Cardiology and Internal Medicine. More than 14 years of clinical experience Former Associate Professor at the University of Pavia, faculty of Medicine Specialization school in Geriatrics. Corporate Clinical Development, (Headquarter Position) April 2013 - present

Amanda has extensive experience in health research, research ethics and patient engagement. She currently works as a freelance consultant and medical writer specialising in lay summaries. Formerly Amanda was Head of Policy and Public Affairs at the Health Research Authority (HRA) in the UK from 2012 to 2019. During th8is time she led an EU wide taskforce to work on the development of EU guidelines for lay summaries of clinical trials. Early in her career she worked for Boots Pharmaceuticals as Head of Business Information for before moving to the Department of General Practice at the University of Sheffield as a Research Fellow. She later took up the post of Director of Research & Development at the Northern General Hospital in Sheffield.

Esteban has worked in both academia and industry in a range of roles including academic research, drug discovery, pharmacovigilance and regulatory policy. Before joining AbbVie, Esteban was Director of Regulatory Intelligence and Policy at Daiichi Sankyo Development Ltd, lead for Pharmacovigilance & Regulatory Affairs at the Association of the British Pharmaceutical Industry (ABPI) as well as working in pharmacovigilance for P&G Pharmaceuticals and drug discovery for Novartis. He holds a Biochemistry BSc from Warwick University, PhD in virology from University College London, and has worked as a postdoctoral researcher at Imperial College London

Development Excellence Leader (Roche), based in the UK. Specialist in Organisational Change and Development. Trained coach, certified learning and development specialist (CIPD) and practitioner in Change Management (PROSCI).

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.

Juliette has worked in the pharmaceutical industry for over 15 years, predominately in the Regulatory Affairs function including regulatory lead roles for global projects. She is currently the in-house subject matter expert and process owner for clinical trial applications, and in this role is accountable for procedural documentation, oversight and continuous improvement of the process. Juliette leads the implementation of the EU Clinical Trials Regulation at Pfizer.

Anastassia Negrouk is holding master's degree in Biology, she specialized during 5 years in cellular biology and biochemistry working in a research laboratory focusing on cancer research. She joined EORTC in 2000; Involved in the regulatory since 2003, she took on her current position in 2011.The follow-up and analysis of EU legislation relevant for clinical research is integral part of her work. SInce 2017 she is also a DPO for EORTC.

John has worked in Regulatory Affairs since 1979 until retiring from Covance, where he had global responsibility for regulatory policy and compliance, in March 2015. John is a former chair of the ACRO European Scientific and Regulatory Committee and now acts as a consultant to ACRO.

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.

Kristof is an industrial pharmacist. Being a Belgian national, he started working for the Belgian Federal Agency of Medicines and Health Products in 2005, and in 2009 he took up the responsibility for the Research and Development division, in charge of clinical trial applications. He was the Belgian member and secretary of the Clinical Trial Facilitation Group, and the Belgian representative in the European Commissions Clinical Trial Expert Group. He was also part of the negotiations of the Clinical Trial Regulation in 2013 and 2014. After a brief period working for the association of the Belgian pharmaceutical industry from 2016 onwards, he joined the EU Commission in 2019.

Dr Martin O'Kane, MRPharmS, studied pharmacy at University of Aston and after completing a PhD and a post-doctorate research project at the University of Glasgow, he moved to Japan to work within the pharmaceutical industry. He joined the MHRA in 2005 as a Pharmacopoeial Scientist with the British Pharmacopoeia and was a member of the European Pharmacopoeia Commission’s Working Party on Cell Therapy Products. He moved to the Clinical Trials Unit as a Pharmaceutical Assessor in 2007 and was involved in the assessment of chemical and biological CTA applications for all phases of study. In 2023, becoming the Regional Head RA EU Policy & Liaison at Novartis.

Ms Lidia Retkowska-Mika is a lawyer and has been mostly working in the health sector. She has been representing Poland in the Council as an expert on EU pharmaceutical legislation proposals, in particular concerning pediatric medicines, pharmacovigilance, falsified medicinal products and clinical trials. She also participates in the activities of the Heads of Medicines Agencies and is a member of EMACOLEX.

Mark spearheaded the design and development of the RxTROSPECT Oncology US and EU modules, Co-founding RxTROSPECT and building a team of US-based clinical and regulatory experts to deliver an innovative, cloud-based technology for oncology strategy professionals. RxTROSPECT was guided from concept to revenue positive within 12 months and currently has a range of US and international clients who rely on RxTROSPECT to identify regulatory precedent, to accelerate innovation and derisk strategy.

More than 16 years’ experience in Clinical Research arena, working for the last 11 years in the industry, bringing experience from different perspective from field monitoring to country and cluster management roles. Currently she is managing the MSD Clinical Research Operations in Romania and Bulgaria. Florina leads the implementation of the EU Clinical Trails Regulation at MSD and act as key member of the Romanian Regulatory Agency and Industry Associations working group focused on implementation of EU Clinical Trial Regulation in Romania.

Sue is a PhD pharmacist. After university she joined SmithKline Beecham Pharmaceuticals followed by Eli Lilly and now is VP for International regulatory affairs. She is currently Chair of the EFPIA “Adaptive Models Priority Working Group”.

Director of Systems & Development, Health Research Authority, UK. Current position: Programme Director HRA Approval, Chair EU Regulation Steering Group for UK Research Ethics Service (HRA). Previous position/Career highlight: Over 20 years’ experience of clinical research in NHS research management and pharmaceutical industry

Noémie Manent is the Operations Lead in the Clinical Trial Transformation team at the European Medicines Agency, facilitating change management for member states and sponsors with the implementation of the clinical trial Regulation. She has played an essential role in the set up of structured summary results for clinical trials. Also, she has experience in the coordination of inspections for marketing authorisation application. Noemie has more than 15 years experience working in clinical R&D for small and medium enterprises in industry and academia mainly in France and the United Kingdom.