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European Regulation Day

This event will bring together at the same roundtable, the representatives of the authorities, industry (pharmaceutical companies and contract research organizations), investigators, academia and patients’ associations to discuss and find together the best ways of moving forward under the new requirements of the Clinical Trial Regulation 536/2014.

Persons who are involved in conducting clinical trials: project management, monitoring, regulatory affairs or pharmacovigilance for clinical trials in a CRO or a Pharma Company, you are a medical investigator or you lead a team of investigators, this event is the right place to learn and raise your questions.

Dr. Martine Dehlinger Kremer President of European CRO Federation (EUCROF); VP President Scientific Affairs, Pediatric SME, PRA Health Sciences
  • Dr. Dehlinger-Kremer’s expertise spans more than 30 years in the research industry, including 29 years of experience in global regulatory affairs, medical affairs, and pediatric leadership.
  • Dr. Martine Dehlinger-Kremer has contributed to global development of numerous products, including orphan drugs and biosimilars. She has participated in 100+ New Drug Applications and Marketing Authorization Applications globally and in clinical studies across all phases.
  • She is an observer Member of the Coordinating Group of Enpr-EMA, the European Network of Pediatric Research at the European Medicines Agency (EMA) and since many years a member of Working Parties of Enpr-EMA. She is Chair of the Pediatric Working Group of EUCROF since 2008, Chair of the European Forum for GCP (EFGCP) Children Medicines Working Party. Martine is also a active in the International Children’s Advisory Network (iCAN).
  • Since 2016, Dr. Martine Dehlinger-Kremer is President of EUCROF, the European CRO Federation.
  • Dr Dehlinger-Kremer was Named One of PharmaVOICE 100’s Most Inspiring People in Life Sciences (Industry leader recognized for impact, experience and advocacy in clinical research) in August 2015.
  • Dr. Dehlinger-Kremer holds a Doctorate in Sciences, a Master of Advanced Study in Neurophysiology, and a Master of Science degree.
Assoc. Prof. Diana Paun Presidential Advisor
  • Assoc. Prof. Dr. Diana Paun (born 1968) graduated the Faculty of Medicine and had a PhD in Medical Science at the "Carol Davila" University of Medicine and Pharmacy in Bucharest. She is a senior specialist in endocrinology and is associate professor at the Endocrinology Department at "Carol Davila" University of Medicine and Pharmacy. She worked at the National Institute of Endocrinology "C. I. Parhon" as a doctor, researcher, professor, and from 2006 to 2015 as a hospital manager. She holds a certificate of complementary studies in Health Services Management and has graduated "Public Health Management and Health Services" Master Program, attended several management improvement programs, quality auditor programs, trainer and an expert in public procurement programs.
  • Dr. Diana Loreta Paun is member in several national professional associations (Romanian Association of Clinical Endocrinology, Romanian Endocrinology Society) and international (German Endocrinology Society, European Society of Endocrinology - ESE), member of the Romanian Association of AACE (American Association of Clinical Endocrinologists) being its chairman between 2011-2012. She published studies and scientific papers in national and international scientific journals. Currently she is working in health management. She was director and team member in several national and international scientific research projects and part of educational and continuing medical education programs. Dr. Diana Loreta Paun was appointed as State Councelor on public health issues at the Presidential Administration of Romania starting with 1st June 2015.
Dr. Roxana Stroe President of National Agency for Medicines and Medical Devices of Romania
  • President of National Agency for Medicines and Medical Devices of Romania
  • He has been working at ANMDMR since the end of 2010. He held the position of coordinator of the Pharmacovigilance and Risk Management Department.
  • Since 2014, he has been a full member of the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency (EMA), and since March 2019, an alternate member of the EMA Management Board.
  • Since March 2019 she is member of the board of the European Medicines Agency.
Monica Emanuela Althamer State secretary, Ministry of Health, Romania
  • State secretary, Ministry of Healty, Romania
  • Vice President of the Association / Patient Navigator MagiCAMP Association, Bucharest
  • Administrative clerk / Patient counselor Theosophy Association, Bucharest
  • Navigator patients diagnosed with severe burns / Voluntary Association „In the name of Alexandru, Sinaia, Prahova
Katarina Kovacova Clinical Trial Expert for Ministry of Health, Institute for Research & Development, BioHub, Slovakia
  • 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.
Prof. Dr. Adrian Streinu-Cercel President of Health Commision, Senate of Romanian Parliament
  • President of Health Commision, Senate of Romanian  Parliament
  • He has extensive experience as director of numerous international research grants and principal investigator in a wide range of multi-centric, multi-national clinical trials Phase I-IV.
  • In June 2009, Prof. Dr. Streinu-Cercel founded the “European HIV/AIDS & Infectious Diseases Academy”, as a post-graduate training and education facility providing direct access to various types of services currently offered by its network members.
  • The HIV European Academy was listed in the five post university schools approved in Romania by the Ministry of Education. The European HIV/AIDS & Infectious Diseases Academy aims to provide direct access to knowledge and practice in the area of treatment and care at the highest standards for health, social and education professionals. The Academy has numerous partnerships with important institution from all over the world (www.aidsacademy.org).
  • Prof. Dr. Adrian Streinu-Cercel hold the position of Chancellor at the “Carol Davila” University of Medicine and Pharmacy, Bucharest.
  • Editor in Chief for several Infectious diseases publication in Romania: the Romanian language edition of “Clinical Infectious Diseases Journal” – Oxford University Journals, since December 2010, The Lancet Infectious Diseases – Romanian language edition, the journal Therapeutics Pharmacology and Clinical Toxicology, since 2006, and for the journal GERMS – since 2011, the official journal of the “European HIV/AIDS & Infectious Diseases Academy”.
Prof. Dr. Pharm. Doina Draganescu Dean of the Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, Bucharest
  • Doina Draganescu graduated in 1988 Carol Davila University of Medicine and Pharmacy, Faculty of Pharmacy.
  • At the beginning she worked as a trainee pharmacist and starting with 1990, she started her university activity as assistant and PhD student at the Department of Pharmaceutical Physics and Informatics. Currently, Doina Draganescu is professor at the same department, and since the graduation she held both professional and administrative activities.
  • The following fields can be mentioned as areas of professional interest: medical and pharmaceutical technologies, homeopathic medicines, radiopharmaceuticals, (graduated European Course of Radiopharmacy EANM) being currently involved in professional activities at Horia Hulubei Institute of Physics and Nuclear Engineering (Magurele) at the Radiopharmaceutical Research Center and since 2017 is Qualified Person in the field of drug production of radiopharmaceuticals and member of the research team of the center as auxiliary personnel, being a member of the research team in several projects realized in collaboration with Carol Davila University of Medicine and Pharmacy, Bucharest.
  • Since 2018 she is a member of the Bioethics Commission of the Academy of Medical Sciences, currently Vice-President, where she is involved in the evaluation of clinical trial applications in Romania, subject to compliance with the Declaration of Human Rights, as well as all specific regulations.
  • Dr. Draganescu is member of the Romanian Pharmacists' College and of Pharmaceutical Society of Romania since 1990, member of the National Society of Chemistry, National Society of History of Pharmacy and other professional societies from Romania or abroad.
  • She has been Vice-Dean for 4 years and since 2016 is Dean of the Faculty of Pharmacy, member of the University's Administration Board and member of the University Senate. She was member of the organization committee of several symposiums and pharmaceutical conferences, including in 2016 and 2018 editions of the national pharmacy congress where she was Chairman of the Organizing Committee and coordinator of the Scientific Committee. She has been manager of several projects dedicated to the development of human resources (POSDRU) in the pharmaceutical field and is currently involved in institutional development projects regarding ethics and academic integrity technologies for increasing the level of didactic activity in the university, expert in university management projects of the Romanian Academy and the Ministry of National Education.
  • Starting with 2012 she is the president of the Bucharest branch of the Pharmaceutical Sciences Society in Romania and represents Romania in the Executive Committee of the European Pharmaceutical Sciences Society. She is currently appointed responsible for the internal audit of EUFEPS.
Prof. Dr.Constantin Mircioiu General Secretary of the National Bioethics Commission of Medicines and Medical Devices, Romania
  • President of Pharmaceutical Dept. Academy of Medical Sciences
  • General Secretary of the National Bioethics Commission of Medicines and Medical Devices, 

Previous positions:

  • Head of the Dept. of Applied Mathematics and Biostatistics, University of Medicine and
  • Pharmacy “Carol Davila”, 1992 – 2012.
  • Dean of the Faculty of Pharmacy, Bucharest, 2004-2008, Chancellor 2008-2012
  • Head of Dept. of Biopharmacy, Army Center for Medical Research,
  • Member in European Center for Validation of Alternative Methods Scientific Advisory Committee, Joint Research Center, Ispra, 2006-2009
  • President of Romanian Society of Pharmaceutical Sciences

Fields of Specialisation

  • Main field: bio-pharmacy and pharmacokinetics;
  • Other fields: pharmaceutical technology, biostatistics.

Current research activities

  • Fundamental research concerning the physicochemical component of the action mechanism of drug molecules at the membranes interfaces; mathematical methods applied in bio-pharmacy, pharmacokinetics, toxicokinetics and clinical pharmacy; applied research in pharmaceutical technology in antidote design, dissolution, bioanalytics and bioequivalence of drugs.
  • Director for Bioequivalence studies at Biopharmacy & Pharmacol Res S. A.
  • Part of research published (85 in ISI scientific journals and volumes), books (“Pharmacological mechanisms at membranar interfaces”, Romanian Academy Publ. House, 1994; Mathematics Applied in Pharmacy, 2000, Biostatistics 2005, 2010, Pharmacokinetics 2008, associated editor for NBC Risks. Current Capabilities and Future Perspectives for Protection, NATO Science Series, Kluwer Academic Publishers, Dordrecht/Boston/London, 1999), Biostatistics, Fundamental Pharmacokinetics etc

Affiliations:

  • Member of the Academy of Medical Sciences
  • American Association of Pharmaceutical Scientists

Awards: Prize “Daniel Daniepolu” of Romanian Academy, 1994.

Assoc. Prof. Dr. Michael Schenker President of The Oncology Commision Ministry of Health and The founder and head of “Saint Nectarie” Oncology Center, Romania
  • President of The Oncology Commision Ministry of Health and The founder and head of “Saint Nectarie” Oncology Center, Romania
  • Assoc. Prof. Dr Michael Schenker, a chief oncologist in Craiova, is one of the few Romanian specialists who have managed to conduct clinical trials of the FDA (Food and Drug Administration, USA) for biological substances against cancer.
  • Dr Schenker is associated professor at the University of Medicine and Pharmacy from Craiova, and the founder and head of “Saint Nectarie” Oncology Center (Craiova), since 2014.
Dr. Catalina SARBU Head of the CRO Association in Romania (ACCSCR)
Director Clinical Operations Parexel International Romania
  • General Manager Business Administration & Director Clinical Operations at Parexel
  • 2004-GMBA and Director Clinical Operations–PAREXEL International Romania S.R.L.
  • 2000–Director of the Romanian Representative office of PAREXEL Nederland BV
  • General Practitioner –Center of Hematology, Ploiesti, Romania
  • Saint Antoine University, Paris, France - Hematology and Blood Transfusion, 1-year courses
  • University of Medicine and Pharmacy, Bucharest, Romania -Medical Doctor Degree
Ingrid Klingmann, MD, PhD, FFPM, FBCPM PHARMAPLEX bv, EFGCP, PharmaTrain Federation

Ingrid Klingmann, MD, PhD, European Forum for Good Clinical Practice (EFGCP), Pharmaplex bv, Brussels, has 30 years of practical experience with planning and performance of clinical trials from a sponsor and investigator perspective in the pharmaceutical industry, CRO and academic institution. Through her activities in multi-stakeholder not-for-profit organisations like EFGCP, she gained broad experience in ethical, quality and regulatory challenges in clinical research and possible approaches to solutions.

  • Physician, specialized in General Medicine, Clinical Pharmacology and Pharmaceutical Medicine with over 30 years of experience in different senior medical, operational and managerial functions in the pharmaceutical industry, CROs and clinical trial sites with focus on clinical trial design and management, ethical and regulatory aspects.
  • Since January 2003 she has her pharmaceutical development and site management support consulting company.
  • Dr Klingmann is Chairman of the Board of the European Forum for Good Clinical Practice (EFGCP). On behalf of EFGCP she was and is involved in different FP7- and IMI-funded projects (ICREL, PatientPartner, PharmaTrain, EUPATI, Combacte-NET, PARADIGM and ConCEPTION) and with her company in the FP7-funded paediatric LENA project. Her broad professional background as a physician with experience in patient care, clinical development, site management and patient engagement enables Dr Klingmann to bridge the gaps between the interests and skills of all different stakeholders in medicines development to develop new patient-relevant treatments more efficiently.
  • Dr Klingmann is also President of PharmaTrain Federation, the not-for-profit organisation focussing on global standardisation and improvement of post-graduate training in medicines development sciences. She also teaches on different clinical research and regulatory affairs topics in diploma and master courses at the University of Bonn, Germany, University of Basel, Switzerland, and the Université Libre de Bruxelles, Belgium.
Mihaela David Director of Regulatory Affairs - PSI Pharma Support Romania
  • Mihaela David is a 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.
  • Her 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.
  • She is a member of DIA since 2014 and part of the exclusive group of experts in clinical trials in Europe.
Vicki Iassonidou Associate Director Global Regulatory Clinical Services, PRA Health Sciences, Germany
  • Vicki Iassonidou has about 18 years of experience in clinical research particularly within the CRO industry. Since 2004 she has been in various positions including global in clinical trial regulatory submissions and study start-up. She has led large teams in a wide range of regulatory and study start-up activities and a variety of therapeutic areas with products including small molecules, monoclonal antibodies, somatic cells, GMOs and controlled substances.
  • Since July 2020 she has been approved by EMA and became EUCROF’s second Product Owner (PO). She joined the Sponsor PO team which is led by Pierre Omnes and participates in the development of the EMA`s Clinical Trial Information System (CTIS) implementation supporting until go-live and thereafter.
  • Vicki Iassonidou holds a Master of Science degree in Biology from the University of Munich (LMU), Germany.
Cristina Florescu Moraid, MD, MSc, EuSpLM, MRQA CEO AVANTYO Institute of Clinical Research, Romania President of Clinical Trials Symposium
  • Dr Florescu Moraid got her Medical Doctor Diploma in 1998 from „Carol Davila” University of Medicine and Pharmacy in Bucharest, Romania and was accredited as Laboratory Medicine Specialist in 2005 and as Senior Laboratory Medicine Specialist in 2011, by the Romanian College of Physicians.
  • She got her Master of Science Diploma for Hospital and Medical Management in 2006, accomplished the Postgraduate School of Clinical Trials Management - Gdansk in 2012 and the Postgraduate Leadership Development Program at University of Sussex - UK, in 2014.
  • Dr Florescu Moraid was responsible for clinical trials operations at Synevo Central Lab, the clinical research wing of Swedish Medicover Group as Regional Director for Romania, Moldova, Bulgaria and Serbia between 2005 and 2018. She has been organizing Synevo Clinical Trials Symposium for 11 years.
  • Since the beginning of 2019, she is Co-founder of Avantyo - Institute of Clinical Research and CEO of Camina Medical Experts, developing tailored CT services for pharma sponsors, CROs and mid-size biotech companies. She is also a member of the Events and Training Working Group of EUCROF (European CRO Federation).
  • She is invited as a speaker for different scientific events and acts as an active advocate for increasing awareness over the importance of developing clinical trials for the patient’s benefit.

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