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. 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, EU Regulatory Policy & Intelligence
- 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 Project Manager, Disclosure
- 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 M. Schindler, PhD
- CT Transparency Team in EFPIA; Head Innovation Medical Writing
- Boehringer Ingelheim Pharma GmbH & Co.KG, Germany
Thomas M. Schindler, PhD (Molecular Physiology). After his post-doc, he went into publishing as a popular science editor and has meanwhile gained some 20 years of experience in both medical affairs and regulatory medical writing. He has a vetted interest in lay language communication and has several publications on this topic. He is currently heading the European Regulatory Medical Writing group of Boehringer Ingelheim Pharma GmbH&Co.KG.
Solange Corriol-Rohou, DrMed, MD, PhD
- Senior Director, Global Regulatory Affairs & Policy, Europe
- Astrazeneca Research & Development, France
Pulmonologist and immuno-allergologist by training, Solange joined AstraZeneca R&D in 2004. Moving from the French Medicines Agency and hospital to Industry, she has gained strategic experience in drug development. As the chair of the EFPIA Clinical Development Expert Group, she has organized workshops with the EMA. She is quite experience working in PPP, was the deputy topic lead of IMI ADAPT SMART, has developed and qualified with the IMI PROactive consortium PRO instruments to assess Physical Activity of COPD patients, and is currently involved in IMI Mobilise-D and Trials@Home projects. She has also joined ICH to complete the revision of the E11 Paediatric guideline, and is keeping the momentum with the E11A Paediatric Extrapolation.
- 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.
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, Site Start-Up & Regulatory
- Syneos Health, France
Pierre-Frédéric Omnes has 19 years of experience in global Clinical Research Organizations and Pharma as Regulatory Affairs consultant and is currently working in Syneos Health, a global CRO, supporting clinical trial activities globally. Pierre is a member and direct contributor (“Product Owner” ) to EMA’s “Clinical Trial Information System” Development initiative since its kick off Mid 2019, and was also involved since 2015 in industry engagement activities for the Portal (EMA CTIS stakeholder meetings, CTIS UATs, CTIS workshops, etc.)
- 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
Alison Bond, PhD
- Director, Global Regulatory and R&D Policy, Global Regulatory Affairs and
- Strategy, AMGEN, United Kingdom
Alison is currently Director in the Global Regulatory Policy & Intelligence group at Janssen (pharmaceutical companies of Johnson & Johnson). In this role, Alison leads regulatory policy efforts aimed at enabling effective delivery of innovative healthcare products to patients worldwide. Alison is the lead for digital health regulatory policy, with a focus on decentralized clinical trials and novel digital endpoints. She represents Janssen on several multi-stakeholder groups and collaborations, such as EFPIA, IMI and TransCelerate initiatives. Alison is a post-doctoral scientist with broad ranging experience gained within the CRO and pharma industry environments, spanning discovery research, clinical, pharmacovigilance and regulatory.
Jan Geissler, MBA
- 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.
Ilona Reischl, PhD, MPharm
- Biologics Quality Assessor
- Federal Office for Safety in Health Care(BASG), 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.
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.
Pierre Omnes, MPharm
- Regulatory Affairs Officer
- Quintiles, 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.