Dr. Surendra Gokhale has gained over the past 23 years, extensive experience of EU, US and global regulatory procedures and had several interactions with EMA/CHMP/FDA and other Global regulators. Currently, he is engaged as one of the capability Development leaders in the Global Regulatory at Roche, and also he is Roche’s business lead for a cross-functional project to implement the Clinical Trials Regulation in the EU. Since many years he is member of the EFPIA and IFPMA Regulatory groups. He has represented EFPIA on ICH M5 activity as well as the topic leader on the ICH E6 update activity completed last year. He will be the EFPIA topic lead for recently initiated ICH M11- Clinical electronic Structured Harmonized Protocol (CeSHarP).

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

Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She joined MSD in 2017 to lead regulatory policy efforts ex-US for innovation that leads to better treatment for patients globally. Since 2020 this scope has expanded, as Ginny now leads the talented and experienced Global Regulatory Policy and Intelligence team for MSD. Her work has regularly focused on policy shocks that challenge innovation and access to novel therapies for patients, including global and industry-wide policy work on BREXIT, COVID-19 and now the R&D impacts of the Inflation Reduction Act.

Pieter Vankeerberghen studied Industrial Pharmacy, obtained a Ph.D. in Pharmaceutical sciences and holds a master degree in informatics. After working for 4 years in R&D, first in Clinical Data Management and later as project manager in human pharmacology, he joined the Belgian authorities in 2000 leading various projects. From 2016 he led their R&D department for clinical trials and unmet medical need. In this role he was a Member State Product Owner for the CTIS project. Since August 2020, he is head of EMA clinical workstream and CTIS programme manager.

Ditte Zerlang Andersen joined the clinical trial department at the Danish Medicines Agency (DKMA) in 2015. Starting as a clinical trial assessor, she now leads strategic European alignments in our regulatory clinical trial landscape as a Senior EU project lead. Ditte led the recent task force delivering the recommendation paper on decentralized elements in clinical trials from the European medicines regulatory network (EMRN) in Dec 2022. Currently, Ditte lead the ‘COMBINE’ project on the CTR, IVDR, MDR interface and coordinates the ACT EU priority area on methodologies. Prior joining DKMA, Ditte worked 5 years in the pharmaceutical industry and have a PhD in neuroscience.

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

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.

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.

Maria Antonia is Head of Clinical Trials on human medicinal products Sector at the Spanish Agency of Medicines and Medical Devices. She has participated as Spanish expert in the Medicines and Medical Devices Council working group during the discussions on the EU draft CT regulation. She has also participated in the preparation of the current national legislation complementary to the EU clinical trials Regulation Nº 536/2014. She is member of the Spanish Coordination Group on clinical trials, including members of Ethics Committees (CEIm) and AEMPS, and also of EU groups working on the applicability of the CT regulation (CTFG and Commission group of experts on clinical trials) and development of EU CT Portal and database (CTIS).

Chrissie is the VP Speciality & Primary Care Statistics at GSK. Chrissie has worked in the Pharmaceutical Industry for over 30 years and has experience of developing and commercialising new medicines in a variety of therapeutic areas across all phases of clinical development. Chrissie is actively engaged in Statistical societies, Pharmaceutical trade associations and initiatives relating to the Pharmaceutical Industry. She is currently the Chair of the Statisticians in the Pharmaceutical Industry (PSI), the EFPIA lead for the Innovation in Clinical Trials Pillar, a working group in the Clinical Research Expert Group, she is one of the PSI representatives on the EFSPI Council and she is the lead for the EFSPI Statistics Leaders Forum.

Karen Kiilerich is a special legal adviser for The National Committee on Health Research Ethic (NEC) in Denmark. NEC is responsible for coordination of activities in the regional committees, issues guidelines, acting as a board of appeal in connection with findings in the regional committees and assess complex cases of clinical research. Karen has a background as Master of Law from the Faculty of Law, University of Aarhus. Before joining the secretariat of NEC in February 2015, Karen has worked as a legal adviser for the regional committees for the capital region since February 2008. And before that Karen worked in public administration within the area of tax (heavy economic crimes) and duty law.

Sandra Petraglia has been working at the AIFA since 2004. Currently Head of Pre Authorisation Department, with close involvement in the national implementation activities and requirements for the Clinical Trials Regulation since 2015, being also the Italian representative at the CTFG and at the EMA and EU Commission groups on implementation of Regulation 536/2014 EU. Medical Doctor by education, Dermatologist and PhD in Dermatological Immunology, her previous activities at the AIFA have been as Clinical assessor, MRP/DCP Coordinator and Italian CMDh member from 2005 to 2016. Previously, she has being working in the fields of Information and Advertising on Medicines and of Dermatological Oncology and Immunological therapy.

Catherine is the Health Research Authority Sr Dvlpt Manager undertaking large scale projects for national policy development and internal service improvement. Since 2011, she has been the Research Ethics Service lead on behalf of the UK for the implementation of the EU Clinical Trial Regulation. Currently leading a large scale UK programme to combine the CT authorisation, Research Ethics Committee and NHS governance submission, review and approval processes, for the implementation of the EU CTR. She also oversees the Phase 1 Advisory Group and is the Research Ethics Service lead for human tissue research; currently writing her PhD thesis, exploring models to maximise and normalise access to human tissue and patient information in the NHS.

The MRC Clinical Trials Unit at University College London specialises in conducting complex, platform clinical trials. Louise works on cancer trials and has an interest in stratified medicine and biomarker clinical validation studies and runs FOCUS4, a molecularly stratified adaptive trial programme in advanced colorectal cancer. She is trained in mechanical engineering but after completing a Master’s degree in medical statistics at the London School of Hygiene and Tropical Medicine she completed her PhD in statistics at Imperial College London (ICL). Prior to working at the MRC CTU, she worked as a statistician at ICL, primarily in cardiovascular surgery trials and with a particular interest in abdominal aortic aneurysm.

Lene Grejs Petersen is Senior Adviser at the Danish Medicines Agency, Clinical Trial Unit. Lene has been member of the Clinical Trials Facilitation Group (CTFG) member since 2008 and the Danish representative of the EU Commission’s expert group concerning clinical trials since 2001. Lene has been an employee at the Danish Medicines Agency since 2000 and she is involved in the implementation of the EU Clinical Trials Regulation into Danish legislation and works as a regulatory assessor and coordinator of clinical trial applications including VHP. Lene has a background as Master in Pharmacy.

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.