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Clinical Trial Regulation Information Day for CEE Countries

Are Central and Eastern European Union member states ready to implement the new EU Clinical Trial Regulation (536/2014)? This information day provides a platform for discussion about the status of the implementation and further compliance with the new Regulation, as well as the associated legislation in the region.


Speakers

  • Steffen  Thirstrup, MD, PhD

    Steffen Thirstrup, MD, PhD

    • Director, NDA Regulatory Advisory Board
    • NDA Advisory Services Ltd, United Kingdom

    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 in pharmacotherapy at the Faculty of Health Sciences, University of Copenhagen. From 2004-9 ST worked at the Danish Medicines Agency (DKMA) acting as the Danish 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 Division. In March 2013 Prof Thirstrup joined NDA Group where currently is the director of Regulatory Advisory Board at NDA Regulatory Services Ltd.

  • Massimiliano  Sarra

    Massimiliano Sarra

    • CTFG Secretary
    • Italian Medicine Agency (AIFA), Italy

    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.Bachelor’s degree in Molecular Biology, PhD in mucosal immunology, Master degree in Regulatory Affairs.

  • Mihaela  David

    Mihaela David

    • Director Regulatory Affairs
    • PSI CRO AG, Romania, Romania

    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.

  • Stefan  Strasser, MD

    Stefan Strasser, MD

    • Head of Clinical Trials, Institute Surveillance
    • AGES, Austria

    Stefan Strasser is a medical doctor and has been working for the Austrian Medicines and Medical Devices Agency as a medical assessor since 2009. Currently he is the head of the department for clinical trials with medicines, medical devices & in-vitro diagnostics and GCP inspections. He an Austrian representative to the Clinical Trials Expert Group, the Clinical Trials Facilitation Group (CTFG) and the Clinical Trials Information System Experts Group. He is also participating in national working groups with stakeholders to implement Regulation (EU) 536/2014 in Austria. His special field of expertise are the regulatory interfaces between clinical trials with medicinal products and medical devices/in-vitro diagnostics.

  • Vladimir  Vujovic, MPharm

    Vladimir Vujovic, MPharm

    • Regulatory and Safety Manager
    • Optimapharm, Serbia

    A Master of Pharmacy and DIA member since student days, I have had the opportunity to work in various fields of pharmaceutical and medical devices safety and regulatory affairs before settling in Clinical Trials regulatory environment. I have a strong interest in EU Clinical Trials Regulation and its impact on European countries on the outskirts of the EU, including Eastern Europe. I like to keep an eye on new technologies and their application in clinical trials. As a rare disease patient, I am genuinely committed to addressing unmet needs of this group of patients. J.R.R. Tolkien wrote “It's the job that's never started as takes longest to finish”, so I am always looking forward to embarking on new regulatory journeys.

  • Vojtech  Kvita

    Vojtech Kvita

    • Pharmacovigilance Specialist
    • PrimeVigilance s.r.o., Czech Republic

    Vojtech joined the Pharmaceutical industry shortly after finishing his Pharmacy Degree at Charles University in Prague and currently is acting as a Senior Pharmacovigilance Specialist at PharmInvent. He quickly gained the experience throughout the wide spectre of processes and roles. Among his other responsibilities, Vojtech is managing the XEVMPD portfolio and electronic transmissions for various clients.

  • Catalina  Sarbu

    Catalina Sarbu

    • Director Clinical Operations, PAREXEL International Romania s.r.l.
    • President of the Romanian CRO Association (ASSCRC) , Romania

    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

  • Camelia  Mihaescu

    Camelia Mihaescu

    • GCP, GLP and PhV Inspections
    • European Medicines Agency, Netherlands

    Camelia has 15 years of experience working in academia, the pharmaceutical industry and in a regulatory agency, in the fields of regulatory affairs, pharmacovigilance and clinical trials. She is a pharmacist by education and has been working at the European Medicines Agency for almost 5 years. In her role Camelia is responsible for the coordination of GCP and pharmacovigilance inspections, taking part in drafting EU guidelines related to GCP and collaborating with international regulatory agencies on inspectional matters. Camelia has a PhD in Pharmaceutical Sciences.

  • Wojciech  Pilecki

    Wojciech Pilecki

    • Head Regulatory Affairs
    • PSI Pharma Support Poland Sp. z o.o., Poland

    Wojciech has more than 12 years of experience in clinical trials and regulatory affairs. He is a member of the Polish Association for Good Clinical Practice and holds a Master’s degree in Biotechnology.

  • Ekaterina Zareva Borcheva-Dancheva, DrMed

    Ekaterina Zareva Borcheva-Dancheva, DrMed

    • Assoc. Director Regulatory Affairs
    • PPD Bulgaria, Bulgaria

    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.

  • Doina  Draganescu

    Doina Draganescu

    • Romanian Central Ethics Committee Vice-President/Co-chair
    • Romania

    Doina Draganescu is a pharmacist by education. 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.

  • Iuliana Daniela  Stanciu

    Iuliana Daniela Stanciu

    • Regulatory Affairs Manager and LSO
    • Amgen Romania SRL, Romania

  • Costin Radu  Ganescu

    Costin Radu Ganescu

    • Vice President
    • European Patients Forum (EPF), Romania

  • Bovan  Dognev

    Bovan Dognev

    • Vice-President
    • Bulgarian Central EC, Bulgaria

  • Katarina  Kovacova

    Katarina Kovacova

    • Former Head of Clinical Trial Department
    • State Institute for Drug Control, 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.