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

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.

Merete Joergensen holds an MSc in Statistics and an MBA in Management of Technology. She has more than 30 years of experience in Clinical Research. From 2004 she has been building up the area of Clinical Trials Disclosure in Novo Nordisk. She is now working as a senior specialist for the area of clinical disclosure. Prior she headed up Biostatistics in Novo Nordisk A/S for 15 years and worked 7 years as a Clinical Statistician at the medical faculty at Copenhagen University. Further she is Clinical Trials Transparency pillar lead, under the Clinical Research Expert Group in EFPIA.

Robert Paarlberg is Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob worked at Pharmacia (Upjohn) and UCB. Bob is former Chair of DIA’s Clinical Trial Disclosure Community. Bob has more than 40 years of pharmaceutical industry experience with the vast majority of his experience in US and international regulatory affairs. Bob has been active in the clinical trial disclosure and transparency space since 2005.

Matthias Zerm is a Lead Expert Clinical Trial Disclosure and R&D Processes at Merz Therapeutics located in Frankfurt/Germany. In this role he coordinates and oversees all clinical trial disclosure activities including registration and results submissions. He is also involved in a wide range of organizational and process-related projects at Merz Therapeutics, such as preparing for the EU-CTR. He is a biologist by training and has >15 years of global experience in the clinical research arena.

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.

Marie Manley leads is Partner and Head of Sidley’s UK life sciences practice. She is a distinguished thought leader and adviser on EU and UK regulatory law and acts as Chairperson of the DIA Legal Affairs Community. Marie advises clients before both national and European courts and the regulatory agencies in the UK and across Europe. She represents leading pharmaceutical and life sciences companies in litigation before the EU and English Courts, as well as before the national and EU regulatory authorities. Marie features prominently in leading bar publications. She earned a LLM from Columbia University School of Law and from Lausanne University; and a Postgraduate Diploma on EU Competition Law from King’s College.

Elisna has over 15 year experience in regulatory strategy at a number of pharmaceutical companies and is currently an Associate Director at Vectura Limited where her responsibilities include the implementation of the Clinical Trials Regulation within the organisation. In addition her role also includes the development of global regulatory strategies for in-house Phase 1 to 3 development projects, which include start-up, continued support of clinical trials and MAA planning. In order to assess the impact of changes in the regulatory environment on the organisation she also represents Vectura at industry meetings and conferences.

Dr. Elena Prokofyeva is head of drug safety unit at the Department of Research & Development, DG PRE, the FAMHP, Brussels, Belgium. She represents Belgium within the CTFG safety subgroup. She initiated and led an update of the Q&A-RSI document within the CTFG. Dr. Prokofyeva holds a research doctorate from the University of Tuebingen, Germany, a Ph.D. and an M.D. from the Northern State Medical University, Arkhangelsk, Russia, and a Master of Public Health from the University of Umeå, Sweden. Harmonization of safety assessment across members of states in Europe, preparation for the implementation of a safety related part of clinical trial regulation, and safeguarding the safety of trial participants are main objectives of her work.

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.

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

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.

Mrs Greet Musch obtained a PhD in Pharmaceutical & Biomedical Sciences @ Free University Brussels. She joined the Pharma Industry for 8 years as responsible for all the chemical and pharmaceutical analytical activities related to the development of new innovative drugs . She moved to the Federal Public Health services as senior quality assessor. Since Aug 2004 she was in charge of the R&D department. On Feb 2009 she has been designed as Director-general for the DG Pre-authorisation in the FAMHP.

Aleksandar Rusanov is a Legal Adviser in the Legal Department of the European Medicines Agency. He is dealing with various legal issues including access to documents, transparency, proactive publication of clinical data, referrals, advanced therapy medicinal products, pharmacovigilance, clinical trials, medical devices, etc. He also appears in Court on behalf of EMA in access to documents cases. Before joining the EMA, Aleksandar was an Associate in a leading international law firm and advised clients on a wide range of matters relating to medicinal products and medical devices. Aleksandar was also seconded to a number of pharmaceutical companies to assist in activities relating to compliance and promotion of medicinal products.

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.

Dr Anne-Sophie Henry-Eude has a degree in pharmacy from the University of Lille in France and postgraduate degrees in Regulatory Affairs and in Pharmacovigilance & Pharmacoepidemiology. She worked in the pharmaceutical industry before joining EMA as product team leader for anti-infectives and later as paediatric coordinator in the HIV and vaccines field. In 2013 she put in place a Service to centralised activities linked to access to documents (Policy 0043) and later Clinical Data Publication (Policy 0070). Since 2021, she is Head of Documents Access & Publication, a Department, which manages transparency activities at EMA.

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

Dr Karen Quigley has a degree in pharmacy from Trinity College Dublin and a postgraduate Masters in Science degree from the same university specialising in the field of controlled drug delivery and rheology. She subsequently obtained her PhD from the Faculty of Medicine, University of London. Karen joined the EMA 15 years ago working in the areas of mutual recognition, scientific advice, veterinary medicines authorisation and availability of medicines. In 2016 she joined the Clinical Data Publication team working on Policy 0070. Prior to joining the Agency, she worked at the Council of Europe in Strasbourg and with the Health Products Regulatory Agency in Dublin.

Michael has worked in clinical research for over 20 years at the UK, European and global level, both in pharmaceutical company and CRO environments. For much of that time, whether in operations or QA, his focus has been on compliance. He is currently a Quality Strategy Lead at Merck Serono Ltd. (Merck KGaA) where his responsibilities include Clinical Trials Regulation implementation. He has also been a member of the Research Quality Association GCP Committee since 2009.

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.

Joined the Agency’s in 2007. Coordination of GCP and Pharmacovigilance inspections, scientific secretariat support to the Pharmacovigilance Inspectors Working Group and related subgroups and involvement in the implementation of the new pharmacovigilance legislation. A veterinary surgeon with specialisation in public health, has previously worked in the pharmaceutical industry in the areas of clinical research and development and Regulatory Affairs.

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.

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.