Clinical Trial Regulation Conference
Nick Sykes, MS
- Senior Director, Global Regulatory Affairs
- Pfizer, Inc., United Kingdom
Currently working in Europe and International regulatory policy and strategy group in Pfizer. Been working for Pfizer since 1998. My main focus - lead a small team providing regulatory policy and strategy to Pfizer organisation particularly regulation of clinical trials. Previous employment includes SmithKline Beecham, Scrip and Cambridge Antibody Technology
Elke Stahl, PhD
- CTFG Co-Chair, Clinical Trials expert
- Federal Institute For Drugs and Medical Devices (BfArM), Germany
Dr. Elke Stahl, Clinical Trial Unit BfArM, Germany. CoChair of the Clinical Trial Facilitation Group (CTFG) and involved in EMA’s EU CT information system groups as BfArM’s representative. Clinical Trials expert. 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.
- Senior Manager, Policy & Research
- Bayer Plc., United Kingdom
Rose-Marie joined Bayer in July 2013 and is a Senior Manager in EU Regulatory Policy & Intelligence, with special responsibility for CTR implementation and Transparency within the Company. Rose-Marie came to Bayer with over 20 years EU regulatory experience in both the prescription and non-prescription healthcare sectors gained within a number of large research based Pharmaceutical Companies; as well as having worked as a Senior Regulatory Consultant in a small CRO. Rose-Marie has a BSc (1st class hons) in Chemistry and Biochemistry.
Ruediger Pankow, DrSc
- Principal Consultant, Regulatory Affairs
- Parexel International, Germany
Ruediger Pankow is currently Principal Consultant Regulatory Affairs at Parexel, where he has 14 years CRO experience in global management of clinical trial applications and regulatory consulting with specific expertise on the EU Clinical Trials Regulation. Representing ACRO for the EU Scientific and Regulatory Committee he has been continuously involved since 2016 in various European Medicines Agency (EMA) stakeholder activities for the EU Clinical Trial Information System (CTIS) development, since 2019 as sponsor product owner for the EMA CTIS delivery model and as CTIS expert for EMA CTIS training modules validation.
- Team Coordinator National Clinical Trial Office
- Central Committee on Research Involving Human Subjects (CCMO), Netherlands
Monique Al obtained her degree in Human Nutrition at Wageningen University & Research (1988). Subsequently she received a PhD in Human Biology in September 1994 at the Maastricht University.. After that she worked for several nutritional and pharmaceutical companies in the field of clinical research. In 2001 she started as a scientific staff member at the Central Committee on Research Involving Human Subjects (CCMO) in The Netherlands. Since July 2017 she is team coordinator of the Clinical Trial Office located at the CCMO.
- Senior Manager, Clinical Records Management, Strategic Clinical Operations
- AbbVie, United States
Scott has over a decade of experience with clinical trial disclosure, initially working for smaller sponsors as a one-person clinical trial disclosure department, to later operating in larger organizations, serving as an expert in summary results reporting and clinical document redaction/anonymization for public disclosure. As part of implementation planning for the EU Clinical Trials Regulation, Scott is AbbVie’s representative in the EMA CTIS sponsor master trainer programme.
Thomas Schindler, PhD
- Director Medical Writing
- BioNTech, Germany
Thomas M. Schindler, PhD, has studied biology and linguistics, was a member of the TransCelerate Return of Results and Clinical Research Access work streams, is contributing to the Good Lay Summary Practice initiative and the Plain Language Summary Guidance of PFMD. He has some 25 years of experience in both medical affairs and regulatory medical writing, and leads the plain language and lay summary initiatives as head of Innovation Medical Writing at Boehringer Ingelheim Pharma.
Solange Corriol-Rohou, DrMed, MD, PhD
- Senior Director, Global Regulatory Affairs & Policy, R&D, Europe
- AstraZeneca , France
Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection and Vaccine/Immune therapies franchise. Over the past 20 years, moving from the French Medicines Agency/EMA and academia to the pharmaceutical industry, she has gained strategic experience in drug development. She is quite active within EFPIA, ICH and IMI, and passionate about pediatric drug development.
- European Forum for Good Clinical Practice (EFGCP), Belgium
Physician, specialised in General Medicine, Clinical Pahrmacology and Pharmaceutical Medicine. Over 25 years of experience in drug development planning, CRO and Site Management, clinical trials legislation and ethics. Teaching clinical research at DIA, Universities of Bonn and Basel.
Mireille Muller, DrSc, PhD, MSc
- Regulatory Policy & Intelligence Director
- Novartis Pharma AG, Switzerland
Mireille Muller Ph.D. has over 20 years of experience in regulatory affairs at the global level, including policy, benefit-risk research, drug development focused in clinical research. Special interest in early development, scientific advice, and technology-enabled clinical trials and digital systems. Involved in several public private partnership IMI programs such as PREFER.
Virginia Acha, PhD, MSc
- AVP, Global Regulatory Policy
- MSD, United Kingdom
Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She recently joined MSD to lead regulatory policy efforts for innovation that will lead to better treatment for patients in Europe, the Middle East, Africa and Asia. In particular, she is supporting work on science policy, regulatory innovation and integrated evidence generation. Before joining MSD, Ginny was the senior spokesman for the industry in the UK for research, medical and innovation policy. She was responsible for ABPI’s work on BREXIT for the life sciences sector. Previously, Ginny worked for Amgen and Pfizer.
Magda Chlebus, MA
- Executive Director, Science Policy & Regulatory Affairs
- EFPIA, Belgium
Magda Chlebus is Executive Director Scientific & Regulatory Affairs at the European Federation of Pharmaceutical Industries and Associations (EFPIA), representing the R&D-based pharmaceutical industry in Europe. Magda and her team are in charge of following policy and legislative developments that influence the research and regulatory environments for the healthcare industry in Europe. She joined EFPIA in 1995. Her experience covers public and government affairs mainly at EU level, on a range of legislative and non-legislative files in the area of research, development and access to medicines and enabling technologies. Magda, a Polish national, holds a Master Degree in Applied Linguistics from the University of Warsaw.
Pierre-Frédéric Omnes, MPharm
- Executive Director
- Transperfect, France
Pierre-Frédéric Omnes recently joined Transperfect Life Sciences & has over 20 years of experience in global CROs and Pharma Companies as Regulatory Affairs consultant, overseeing numerous multinational clinical trial applications globally. He is a subject matter expert on SSU and Regulatory Operations in global clinical trials as well as on the EU CTR 536/2014 for corporate readiness, implementation, EU Portal, transparency. Pierre is part of the EMA-led initiative developing the CTIS as Lead Product Owner representing the Industry & Academia, continuing his engagement of several years in User Acceptance Testings, Workshops and Analysis& Design sessions related to the system development.
- Scientific Administrator, CTIS expert
- European Medicines Agency, Netherlands
Laura qualified as pharmacist before joining the EMA in 2009 in the Compliance and Inspection Department where she was responsible for the coordination and follow up of GCP and Pharmacovigilance inspections requested by CHMP. Since 2017 she has been working on the development of the Clinical Trial Information system (CTIS), defining and testing the system functionalities in collaboration with the MS and sponsors product owners and the European Commission.
Ghislaine Van Thiel, PhD, MSc
- Ass. Professor Medical ethics
- University Medical Center Utrecht, Netherlands
Ghislaine van Thiel studied Health Sciences and specialized in Medical Ethics and Philosophy of Science. Currently she is Associate Professor Medical Ethics at the Julius Center of the University Medical Center Utrecht (UMCU). Her main research topics are ethics of drug regulation and development, and clinical ethics. Ghislaine is a member of the Dutch Health Council and chair of the Medical Research Ethics Committee METC Utrecht.
Brian Barnes, MA
- Senior Director, Product Development - RBQM
- Medidata, A Dassault Systèmes company, United States
Brian Barnes is a Senior Director, Product Development – RBQM for Medidata Solutions. Brian has 16 years in clinical development and has specifically supported RBQM for ten years specializing in operational solutions for small to large pharma, biopharma, and biotech companies. Brian is a co-liaison within the Association of Clinical Research Organizations (ACRO) RBQM Working Group and presented and published on the topic of RBQM at industry meetings, conferences, and journals. Brian received his Bachelor of Science in Kinesiology from San Diego State University and Master of Art in Human Physiology from the University of Texas at Austin.
Alison Bond, PhD
- Director, Global Regulatory and R&D Policy
- AMGEN, United Kingdom
Alison is currently part of the Global Regulatory and R&D Policy group at Amgen, with responsibility to advance regulatory policy strategic goals on key topics in Europe, Latin America, Middle East & Africa and Canada (ELMAC). In this role, and her previous role at Johnson & Johnson, Alison leads in external advocacy and engaging in multi-stakeholder groups and initiatives, such as through EFPIA, IMI and TransCelerate. For TransCelerate, Alison currently holds the position of Liaison to the European Medicines Agency, leading engagement across the TransCelerate portfolio. Alison is a post-doctoral scientist with broad ranging R&D experience, gained within the CRO and biopharmaceutical industry environments.
Greet Musch, PhD
- General Director
- FAMHP, Belgium
Mrs Greet Musch obtained a PhD in Pharmaceutical & Biomedical Sciences @ Free University Brussels. She joined the Pharma Industry for 8 years as responsible for all the chemical and pharmaceutical analytical activities related to the development of new innovative drugs . She moved to the Federal Public Health services as senior quality assessor. Since Aug 2004 she was in charge of the R&D department. On Feb 2009 she has been designed as Director-general for the DG Pre-authorisation in the FAMHP.
Ilona Reischl, PhD, MPharm
- Biologics Quality Assessor
- Austrian Medicines and Medical Devices Agency (AGES MEA), Austria
Ilona Reischl joined the Austrian Agency in March 2006 and is currently an assessor within the clinical trials unit that is responsible for the evaluation of clinical trials with medicinal products and medical devices as well as GCP inspections. Her background is that of a quality assessor of biologics including Advanced Therapy Medicinal products and she is the Austrian member of the European Medicines Agency Biologics Working Party and the Committee for Advanced Therapies. Her regulatory expertise in Clinical Trials, Non-interventional studies, scientific advice and compassionate use procedures reflect a strong interest in the development of biological medicinal products.
Jan Geissler, MBA
- Managing Director
- Patvocates, Germany
Founder and Managing Director of Patvocates. Former Director of the European Patients' Academy (EUPATI). Cancer survivor and co-founder of the CML Advocates Network, the Leukemia Patient Advocates Foundation, LeukaNET, Leukämie-Online and the European Cancer Patient Coalition.
Merete Joergensen, MBA, MSc
- Clinical Disclosure and Transparency Expert, Former EFPIA, CREG Clinical Trials
- Independent, Denmark
Merete Joergensen holds an MSc in Statistics and an MBA in Management of Technology. She has more than 30 years of experience in Clinical Research. From 2004 she has been building up the area of Clinical Trials Disclosure in Novo Nordisk. She is now working as a senior specialist for the area of clinical disclosure. Prior she headed up Biostatistics in Novo Nordisk A/S for 15 years and worked 7 years as a Clinical Statistician at the medical faculty at Copenhagen University. Further she is Clinical Trials Transparency pillar lead, under the Clinical Research Expert Group in EFPIA.
- Global Alliances Manager
- Lymphoma Coalition , France
Ulrich Jaeger, DrMed
- Medizinische Universität Wien, Austria
Ulrich Jaeger is a Professor of Hematology and the Head of the Division of Hematology and Hemostaseology at the Medical University of Vienna/Vienna General Hospital. His focus is on the translation of medical research into clinical applications in the fields of leukemia and lymphoma. Recently, precision medicine approaches, including randomized trials have been conducted in his Division. On a strategic level, he has been president of the European Hematology Association and is currently co-chair of the EMA Health Care Professional Working Party.
Kristof Bonnarens, MPharm
- Policy Officer Pharmaceuticals
- European Commission, Belgium
Kristof is an industrial pharmacist. Being a Belgian national, he started working for the Belgian Federal Agency of Medicines and Health Products in 2005, and in 2009 he took up the responsibility for the Research and Development division, in charge of clinical trial applications. He was the Belgian member and secretary of the Clinical Trial Facilitation Group, and the Belgian representative in the European Commissions Clinical Trial Expert Group. He was also part of the negotiations of the Clinical Trial Regulation in 2013 and 2014. After a brief period working for the association of the Belgian pharmaceutical industry from 2016 onwards, he joined the EU Commission in 2019.