Legislative status and clarifications regarding the submission dossier as well as the duration of the approval of clinical trials in Romania in 2022, considering the transition from the European Directive to the new Clinical Trials regulation EU No. 536/2014

• Razvan Mihai Prisada is a pharmacist and a Doctor of Pharmacy and has occupied the position of Vice President of the Romanian College of Pharmacists since 2016.
• In 2019, having extensive experience in the pharmaceutical field and in national and European medicinal product policies, Razvan Mihai Prisada coordinated, as chair, the activity of the Working Group on Pharmaceuticals and Medical Devices within the Council of the European Union.
• Razvan Mihai Prisada  has graduated the Faculty of Pharmacy of the University of Medicine and Pharmacy "Carol Davila" Bucharest.  

• 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.

• 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.

• 2004-2022 GMBA and Director Clinical Operations - PAREXEL International Romania S.R.L.
• 2000-2022 Director of the Romanian Representative office of PAREXEL Nederland BV
• Former President of the CRO Association in Romania (ASSCRC)
• 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

• 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 in 2006 , accomplished Postgraduated School of Clinical Trials Management, Gdansk in 2012 and the Postgraduated Leadership Development Programme 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 2005-2018. She has been organizing Synevo Clinical Trials Symposium for 10 years.
• Since 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 invited speaker for different scientific events and acts as active advocate for rising awareness over the importance of developing clinical trials for the patient’s benefit.