Meet Confirmed Speakers from National and Global Agencies
Learn more below about these leaders of today.
Dr Marianne Lunzer, Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care
AGES, Austria
Marianne is a medical doctor by training and joined AGES in 2008 as a pharmacovigilance assessor. She was an alternate PRAC member between 2015 and 2017. In 2017, she joined the clinical trial unit at AGES as a safety assessor and has since been part of the Clinical Trials Facilitation and Coordination Group (CTFG) group. Since 2022 she is chairing the group now called Clinical trials coordination group (CTCG). Marianne contributed to the CTFG best practice guidelines for safety assessors for clinical trials and is a member of the drafting team for the Commission implementing regulation for the cooperation in safety assessment of clinical trials.
Nielsen Lars Bo, Director General
Danish Medicines Agency (DKMA),Denmark
Lenita Lindström
, ICH Assembly Chair and Senior Expert
European Commission
, Belgium
Mrs Lindström-Gommers is the Chair of the ICH Assembly. She is working as a Senior Expert in the Directorate General for Health and Food Safety (DG SANTE) in the European Commission where she is in charge of international relations in the field of pharmaceuticals. Mrs Lindström-Gommers has over 20 years experience in the European Commission, including over 10 years in the field of pharmaceuticals. She holds a Master of Laws degree from the University of Helsinki, Finland.
Hannah-Marie Weller, Directorate-General Communications Networks, Content and Technology
European Commission, Luxembourg
Ms. Katherine Serrano, Director, Latin America, Office of Global Policy and Strategy
FDA, United States
Katherine (Katie) Serrano is the Director of the Latin America Office in FDA’s Office of Global Policy and Strategy (OGPS). Before assuming this role in 2017, Ms. Serrano served nine years in the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health’s Office of In Vitro Diagnostics and Radiological Health (CDRH). While at CDRH, Katie worked as a scientific reviewer, as the Diabetes Diagnostic Branch Chief and the Deputy Director of FDA's Division of Chemistry and Toxicology Devices. She also served as the technical and policy lead for the Agency’s efforts related to Laboratory Developed Tests.
Shannon Thor,
International Policy Analyst, Office of Global Policy & Strategy, Europe Office
FDA, United States
Lieutenant Commander Shannon Thor is a pharmacist and officer in the United States Public Health Service. She serves as an International Policy Analyst in FDA’s Europe Office where she is responsible for providing leadership and technical expertise on international public health initiatives and US-European Union relations. Her previous experience at FDA includes policy advisor roles in the Office of Health and Constituent Affairs and the Office of New Drugs. Prior to FDA, LCDR Thor served as an officer in the US Navy, where she supervised pharmacy operations and directed medication safety programs at military medical centers around the world.
Dr Katherine Tyner,
FDA Liaison to the EMA, Office of Global Policy and Strategy, OC
FDA, United States
Dr. Katherine Tyner is the FDA liaison to the EMA. Dr. Tyner joined FDA in 2007 and has held numerous positions within CDER to advance the quality, safety, and efficacy of complex drug products. In her most recent role as the Associate Director for Science in the Office of Pharmaceutical Quality (OPQ), Dr. Tyner led the OPQ Science Staff in coordinating the intersection between science, review, and policy as well as facilitating interactions among FDA Centers and Offices. Prior to her appointment as liaison, Dr. Tyner was in the Office of Science and Technology Policy within the Executive Office of the President working on efforts to increase technology transfer across the research, development, and deployment continuum.
Loana Ulea, Senior Policy Advisor
FDA, Belgium
Dr Sonja Beken,
Chair 3Rs Working Party, EMA; Coordinator Non Clinical Evaluators
FDA,Belgium
Sonja Beken is the Coordinator of the Unit of non-clinical evaluators at the Belgian Federal Agency for Medicines and Health Products. This Unit is responsible for the evaluation of non-clinical data submitted to support all phases of drug development.
She is Chair of the 3Rs Working Party and member of the Non-clinical Working party at the European Medicines Agency. Over the years, Sonja Beken contributed to the direct identification of opportunities for regulatory implementation of 3R testing paradigms through her active involvement in large-scale international initiatives (e.g. ILSI HESI).
Her main areas of expertise relate to regulatory science, non-clinical drug development, (in vitro) toxicology and metabolism and 3Rs.
Dr Olga Kholmanskikh Van Criekingen,
Clinical Assessor
FDA,Belgium
Olga Kholmanskikh is a clinical assessor at the Federal Agency for Medicines and Health Products (FAMHP), a Belgian National Competent Authority, since 2012. She is an MD by training and holds PhD in Biomedical and Pharmaceutical Sciences. She leads the Complex Clinical Trials (CCTs) working subgroup at Clinical Trials Coordination Group (CTCG) of the Heads of Medicines Agencies (HMA).
Christophe Lahorte,
Head of National Innovation Office and Scientific-Technical Advice Unit
FDA,Belgium
Dr. Christophe Lahorte, PhD. performed academic research for 6 years at the Gent University. Since 2004 he has been actively involved within the R&D department of Belgian agency for medicines and health products (FAMHP) in the quality assessment of CTA’s and PIP’s. In 2009, Dr. Lahorte was appointed as head of the FAMHP’s Unit for National Scientific-Technical Advice & Knowledge Management. In 2017, he became the Head of the FAMHP’s National Innovation Office which aims to support and guide all types of innovators developing new innovative drug products and medical technologies in Belgium and Europe. In addition, he is actively involved in several European projects coordinated by the EMA and European Commission including the ACT EU.
Karl Broich,
President
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Physician, MD (certifications in Neurology, Psychiatry, Behavioural Psychotherapy). BfArM in Bonn (Germany): 2000 to 2014 several executive functions, since 08/2014 head (President). Work in several EMA committees. Current research: clinical trials methodology CNS, biomarkers in drug development, Alzheimer’s disease and other neurodegenerative disorders.
Harald Enzmann,
Chair, CHMP; Head of European and International Affairs
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Harald Enzmann is chairperson of EMA’s Committee for Medicinal Products for Human Use (CHMP). A physician by training, Harald held positions at the German Cancer Research Center (dkfz), at the Intitute of Pharmacology and Toxicology at the University of Erlangen, at R&D at Bayer and at the American Health Foundation in Valhalla, NY, USA. He received the dkfz award for outstanding research and the Animal Welfare Research Award of the German Ministry of Health. In 2002, Harald joined the Federal Institute for Drugs and Medical Devices (BfArM) and is currently head of European and International Affairs.
Barbara Kovacic Bytyq, Head of Department for Pharmacovigilance and Rational Pharmacotherapy
HALMED, Croatia
Dr Mümün Gencoglu,
Regulatory Affairs Manager
IFPMA, Switzerland
Dr Lorraine Nolan,
Chief Executive
Health Products Regulatory Authority (HPRA), Ireland
Ms Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming the role of Chief Executive she was Director of Human Products Authorisation & Registration. Ms Nolan is a member of the Management Board of the European Medicines Agency (EMA), and is also it’s vice chair. Ms Nolan is also a member of the EU HMA Management Group.
Aimad Torqui, Head of Division Medicines Evaluation Board
Medicines Evaluation Board (MEB), The Netherlands
Aimad Torqui is Director of Global Regulatory Policy at MSD. Previous employment. He has worked with governments, regulators, trade bodies and other external stakeholders to shape robust science-based regulatory policy.
Esther De Vries, Pharmacovigilance Assessor
Medicines Evaluation Board (MEB), The Netherlands
Esther de Vries is a pharmacovigilance assessor at the Dutch national agency (MEB), while finishing her PhD at the University Medical Center Groningen in the Netherlands. Her PhD centres around the Direct Healthcare Professional Communication (DHPC) in the hospital setting in the Netherlands. In addition to these activities, she is involved in digitalising the DHPC in the Netherlands.
Peter Mol, Professor, UMCG; Member SAWP, Principal Assessor,
Medicines Evaluation Board (MEB), The Netherlands
Peter Mol is a principal assessor at the Dutch Medicines Evaluation Board and a member (vice chair) of EMA’s Scientific Advice Working Party. He is chair of the EMA Cross-Committee Task force on Registries. He is also a professor of drug regulatory science at the University Medical Center Groningen. His research interest is in the area of regulatory science; from new tools to optimize regulatory decision-making (especially impact of personalised medicine and real world evidence), to improve knowledge transfer and with a specific interest in safety communication.
Peter Van Ven, Methodology assessor and Associate Professor in Clinical Trial Methodology
Medicines Evaluation Board (MEB), The Netherlands
Peter van de Ven is a Biostatistician affiliated to both the Dutch Medicines Evaluation Board (CBG-MEB) and the University Medical Center Utrecht (UMCU). At the CBG-MEB, he works as a Methodology Assessor. At UMCU, he is an Associate Professor and Head of the Clinical Trial Methodology group within the Department of Data Science and Biostatistics. From 2009 to 2021, he was an Assistant Professor in Biostatistics at the Amsterdam University Medical Centers, location VUmc. He has been involved in design and analysis of trials across a wide range of medical disciplines, including oncology, cardiology and psychiatry. His methodological research focuses on innovations in clinical trial methodology, including adaptive and Bayesian methods.
Marcel Hoefnagel, Senior Assessor Biopharmaceuticals
Medicines Evaluation Board (MEB), The Netherlands
Marcel Hoefnagel is an expert in Biopharmaceuticals working as Senior assessor for the Medicines Evaluation Board (CBG-MEB) the Netherlands. Since 2002 he is a regulator CMC of biopharmaceuticals (registration, GMP and legal aspects) as specialist in vaccines, allergens, biosimilars, immunogenicity, gene therapy and cell-based medicinal products. One of his interests is early patientacces. He was involved in organising a EMA/FDA workshop (2018) on Regulatory challenges in early access approaches for pharmaceuticals.
Dr Bianca Mulder, Pharmacovigilance Assessor
Medicines Evaluation Board (MEB), The Netherlands
Bianca Mulder is a pharmacist with a PhD in pharmacoepidemiology. Her research focused on the use of medication during pregnancy and the development of atopic diseases in children. She worked briefly in a pharmacovigilance position at a pharmaceutical company before she started working as a pharmacovigilance assessor at the Dutch national agency (MEB) in 2016.
Dr Sabine Straus, PRAC Chair, Staff Member
Medicines Evaluation Board (MEB), The Netherlands
Dr. Sabine Straus has been with the Medicines Evaluation Board (MEB) in the Netherlands since 1997, where she started as an Assessor Pharmacovigilance. Prior to working at the MEB she held different positions in the pharmaceutical industry, her last job as Medical Director at Searle Monsanto in the Netherlands. As of July 2012 she is the Dutch member in the Pharmacovigilance Risk Assessment Committee (PRAC). In addition to her work at the MEB she holds a position as associate professor at the Erasmus Medical Center, department of Medical Informatics in Rotterdam. Her main research focus is on additional risk minimisation, pregnancy prevention programs, biologicals, signal detection and signal management.
Kenichi Tamiya,
Associate Executive Director
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Mr. Kenichi Tamiya is the Associate Executive Director for New Drug Evaluation at PMDA and is in charge of supervising the review of new drugs except for vaccines and regenerative medical products. Before assuming his current position in 2020, Mr. Tamiya was the Pharmaceutical Management Director, Medical Economics Division at MHLW and was responsible for Reform of Drug Pricing System. Mr. Tamiya has over 25 years' experience in MHLW, including new drug review at the Pharmaceuticals and Medical Devices Evaluation Center, National Institute of Health Sciences, post-marketing safety measures and promotion of R&D for innovative medical products. Mr. Tamiya holds a Master's degree in Pharmaceutical Sciences form the University of Tokyo.
Dr. Shinobu Uzu,
Senior Executive Director
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Shinobu Uzu is the Senior Executive Director, PMDA and in charge of the Safety offices, Office of International Programs, and Regulatory Science Center since April 2020. He took Ph.D. in Pharmacy from the graduate school of the University of Tokyo and has over thirty years of experience in MHLW, PMDA.
He worked for new drug review as Director of the Office of New Drug I and Associate Executive Director for new drug review, PMDA and safety management for drugs and medical devices as Chief Safety Officer, PMDA and Director of Safety Management, MHLW.
He also worked for international affairs as ICH steering committee member on behalf of MHLW and 1st Secretary of the Embassy of Japan in Indonesia.
Momir Radulovic,
Executive Director
Slovenian Medicines and Medical Devices Agency (JAZMP), Slovenia
Momir Radulovic leads the Slovenian Medicines and Medical Devices Agency since December 2018. He is a member of EMA Management Board, a member of EC Pharmaceutical Committee, HMA Management Group, Chair of EURIPID Board of Participants and member of EU Network Training Centre Steering Group. His previous work experience includes Hospital and Community Pharmacy and Pharma industry, focused on oncology medicines, HIV and vaccines. By living and working in countries with diverse Health systems and cultural environments he has learned to adapt swiftly to changes and to seize the opportunities that those can offer. He has track record of strong results, enjoy prioritizing, simplifying complex ideas and acting on them with high levels of energy.
Helerin Eiche,
Quality Assessor
State Agency of Medicines, Estonia
Helerin Eiche obtained her PhD degree in Cell Biology in 2016 and since then she has been working as a quality assessor for biotechnological medicinal products at the State Agency of Medicines (Estonia). She is mainly involved in the assessment of the quality part of clinical trial and centralised marketing authorisation applications. In addition, she is a member of the EMA Biologics Working Party (BWP). Helerin is interested in the development and life-cycle management of biopharmaceutical medicinal products with focus on monoclonal antibodies. Her other possession is the emerging field of phage therapy. She also aims to enhance awareness of environmental/sustainability issues in CMC within the EU regulatory network.
Dr Alireza Khadem Broojerdia,
Team Lead, Regulatory System Strengthening
World Health Organization (WHO), Switzerland
Dr Alireza KHADEM is currently a scientist of the WHO working in the Regulatory Systems Strengthening team. His work is aimed to support WHO Member States to build their national capacity for regulating medical products. During his career in WHO, he has been involved in developing WHO guidelines, as well as benchmarking tools for regulatory systems and organizing and conducting numerous NRA assessments. He has planned and performed many in country trainings during mentioned period.
Jean Pierre Nyemazi,
Senior Advisor
World Health Organization (WHO), Switzerland
Dr Jean Pierre Nyemazi works at the World Health Organization (WHO), where he coordinates a Quadripartite Joint Secretariat team focusing on multisectoral activities against AMR, including the development of integrated surveillance systems for AMR/AMU, estimating the burden and economic impact of AMR and supporting the Global Governance Structures. Before joining WHO, he was the Permanent Secretary of the Ministry of Health of Rwanda.
Samvel Azatyan, Team Lead, Regulatory Convergence and Networks (RCN/REG)
World Health Organization (WHO), Switzerland
Mr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 20 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration, convergence and harmonization, as well as regulatory capacity building and facilitation of products introduction in the countries. Dr Azatyan has also led various projects aiming at development of national regulatory systems, as well as the development and implementation of the concept of reliance in regulation of medical products. Dr Azatyan is currently leading the Regulatory Convergence and Networks Team at the WHO's Headquarters in Geneva, Switzerland.
Vasee Moorthy, Science Division
World Health Organization (WHO), Switzerland
Dr Vasee Moorthy is a Physician with a PhD in malaria immunology, and a background as a Clinical Trials PI and funder. His current main activity at WHO is coordination of development of guidance on best practices for CTs for improving the quality of evidence. In his 14 years at WHO, he has led policy development for the 1st malaria vaccine, set up the horizon scanning process for vaccine R&D, coordinated large CTs consortia for Ebola vaccines and COVID-19 therapeutics (the global solidarity trial), and led the creation of R&D processes at WHO including Target Product Profiles and Coordinated Scientific Advice. He has a medical degree and PhD from the Univ of Oxford and a first class degree in Natural Sciences from the Univ of Cambridge.
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