Mihaela David, Director RA department at PSI CRO AG, based in Bucharest. Senior Pharmacist by education, with 15+ years of experience in the pharmaceutical and clinical trials industry, responsible for coordinating regulatory submissions and related processes in multiple European countries. My main focus of activities is related to the implementation of the Clinical Trial Regulation in PSI and to the compliance with the pharmaceutical and quality related European guidelines. I am a member of DIA since 2014, the organization that offered me the opportunity to be part of the exclusive group of experts in clinical trials in Europe.

Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen. From 2004-9 ST worked at the Danish Medicines Agency acting as member of CHMP and additionally CAT at the European Medicines Agency. Following a short period involved in developing best practice guidelines for primary care ST rejoined the DKMA as Head of the Licensing. From 2013-22, Prof Thirstrup worked asdirector and strategic consultant for NDA Group AB. From June 2022 Prof Thistrup is the Chief Medical Officer of the European Medicines Agency.

Radoslaw Sierpinski, MD is a cardiologist and manager specializing in management in the medical sector, clinical trials, HTA and the science manager. He is a graduate of the First Faculty of Medicine at the Medical University of Warsaw and obtained the title of Master of Business in Medicine at Lazarski University in 2019. He was appointed to the Political Cabinet of the Minister of Health as an advisor in 2018. He cooperated with the Foundation & the Association for Patients with Heart Arrhythmias - Heart for Arrhythmia. His interests include innovative technologies, management and commercialization of research. He is a member of several councils & committees including the European Commission expert group in the field of clinical trials.

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.

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.

Stefan Strasser trained as a medical doctor at the University of Innsbruck in Austria. He joined the Austrian Medicines and Medical Devices Agency in 2009 as a clinical assessor. His special interest are the regulatory and process aspects of clinical trials with medicinal products, medical devices and IVDs as well as their interfaces (combination products and combination trials). He is a member of several working groups of the EC and the EMA, including the CT Experts Group on Clinical Trials, the Clinical Trials Facilitation Group and the EUDAMED CI/PS WG. Since 2019 he is the head of the department of clinical trials and responsible for the implementation of the various regulations (CTR, MDR and IVDR) regarding clinical trials.

Vojtech is a qualified expert in drug safety and pharmacovigilance with extensive experience gained through working on different positions across all PV areas. The wide exposure to global clients (both sponsors and MAHs) has helped him to gain a comprehensive overview of critical PV processes and systems. Vojtech’s main expertise is advance pharmacovigilance consulting, EU QPPV activities, signal management, ICSR management, EudraVigilance support, XEVMPD/ISO IDMP, PV auditing and medical writing.

Programme Assurance Manager in the Clinical Trials Information System (CTIS) programme managed by the European Medicines Agency to enable implementation of the Clinical Trials Regulation (CTR). Educational background and degrees in veterinary medicine, toxicology and social sciences. More than 20 years of experience alternating between private and public sector in the area of medicines, including in research and development, assessment and regulation of medicines as well as management at EU & national level. At EMA since 2005.

Medical doctor by background; holds PhD in clinical genetics. Since 1999 working full-time for clinical trial sponsors, previously at various positions, e.g. Clinical Research Associate, Quality Assurance Manager, and Associate Director Clinical Operations. Since 2012 member of a global clinical development team at Wockhardt Bio, dedicated mostly to novel antibiotics and biosimilars. Board member and head of the standing working group dedicated to ethics review of clinical trials at Polish Association for Good Clinical Practice (GCPpl).

Clinical research professional with 12 years of broad CRO and pharmaceutical experience concerning all phases & types of clinical trials. Since 2016 board member and chairman of the Training Section at Polish Association for Good Clinical Practice, the largest professional non-profit industry organization in Poland. Lecturer at international conferences and Polish universities. The originator and leader of local industry competition “Clinical Trials Leaders”. The originator and leader of many industry educational initiatives. Specializes in data protection within clinical trials and e-health solutions used in the industry. Expert of the Medical Research Agency in the field of CTR implementation.

Ekaterina has 3 yrs. of experience as physician in the Immunohematology dept. at the Nat. center of Hematology & Transfusion Medicine & 18 yrs. in the pharmaceutical industry both clinical trials and post-marketing services. She led clinical, regulatory & PV teams & communicated with authorities regarding regulatory submissions (EMA, BDA, EOF, Turkish MoH). Her large expertise includes clinical, regulatory and safety in Clinical Trials (mainly in Oncology, Hematology, Cardiology and Respiratory diseases), development of start-up CT procedures for EU and MENA region as well as PV procedures for EU and PV trainings for EU and USA, dQPPV responsibilities, Medical writing, Life Cycle Management, Clinical systems implementation & Support in BD.

Ewa Oldak is a graduate of the Faculty of Biology at the University of Warsaw in Poland. Above 10 years she worked as scientist; she specializes in medical microbiology. She joined he Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in 2008. Since 2016 Ewa is the head of the Department of Clinical Trials od Medicinal Products. Since 2009 she is a member of the HMA Clinical Trial Facilitation Group.

Katarina Kovacova graduated from the Comenius University in Slovakia, Faculty of Natural Sciences. Since 2000 Katarina worked for Contract Research Organizations responsible for Czech and Slovak republics. Since 2009 Katarina has also been acting as an expert adviser for regulatory affairs in Slovak and Czech Republics, and as an opinion leader for drug law development. Since 2018 obtained a permanent position in Slovak regulatory agency as a Head of Clinical trial department. She provides GCP training to investigators, CRAs, study team members.

Manager of Contracting Department at Medical Research Agency, MA in law, attorney trainee at The Warsaw Bar Association, graduate of postgraduate studies in clinical trials - methodology, organization and management organized by the Collegium Medicum of Jagiellonian Univ. Member of the Team for the development of Polish draft act on clinical trials on medicinal products. Worked in the Ministry of Health as a senior specialist where she coordinated work on the draft act on clinical trials of medicinal products in connection with the entry into force of the Regulation of the European Parliament and of the Council (EU) No. 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.

I am a Medical Doctor, Specialised in Internal Medical and Clinical Pharmacology. I have been working in the National Agency in Romania since 2002. In work in the field of clinical trials from 2008 as a clinical assessor. I was appointed as head of the Clinical Trials Unit in 2009.