Speakers
Robert Paarlberg, MS
Principal, Paarlberg & Associates LLC, United States
Robert Paarlberg is Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob worked at Pharmacia (Upjohn) and UCB. Bob is former Chair of DIA’s Clinical Trial Disclosure Community. Bob has more than 40 years of pharmaceutical industry experience with the vast majority of his experience in US and international regulatory affairs. Bob has been active in the clinical trial disclosure and transparency space since 2005.
Merete Joergensen, MBA, MSc
Clinical Disclosure and Transparency Expert, Former EFPIA, CREG Clinical Trials , Merete-J Consulting CVR: 34920818, 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.
Gerard Lynch
Associate Director, Clinical Operations, Biogen, United Kingdom
Matthias Zerm, PhD
Lead Expert, Clinical Trial Disclosure and R&D Processes, Germany
Matthias Zerm is a Lead Expert Clinical Trial Disclosure and R&D Processes at Merz Therapeutics located in Frankfurt/Germany. In this role he coordinates and oversees all clinical trial disclosure activities including registration and results submissions. He is also involved in a wide range of organizational and process-related projects at Merz Therapeutics, such as preparing for the EU-CTR. He is a biologist by training and has >15 years of global experience in the clinical research arena.
Anne De Bock
Sr Regional Director , AstraZeneca, Belgium
Pharmacist with 25 years experience in Regulatory Affairs in Veterinary, Biotech and now in AstraZeneca in Oncology and Infection. Main interest is the European Regulatory environment. Also, over 20 years of experience in trade association work.
Angelika Joos, MPharm
Executive Director, Global Regulatory Policy, MSD, Belgium
Angelika Joos is a trained pharmacist. She is responsible for Regulatory Policy issues within MSD's Global Regulatory Affairs and Clinical Safety department. This role includes identifying regulatory policy priorities that align with MSD’s business priorities, leading cross-functional networks to define policy positions, and informing MSD’s regulatory strategy development. Angelika represents MSD in the IFPMA Regulatory Science Committee and is one of IFPMA's delegates to the ICH Management Committee. She is also involved in international policy activities though efpia as well as BIO and PhRMA international Committees. She served on the DIA Board of Directors from 2013-2020.
Tom Bosch, PhD
Director, Clinical Registry, Netherlands
Tom Bosch is head of the Clinical Registry at Janssen with responsibilities over all registries worldwide. He has over 20 years experience in clinical R&D with various roles in clinical trials operations, in business process management and in quality. He has been working in registry and disclosure since early 2013.
Ronald Boumans
Senior Global Regulatory Consultant, EMERGO, Netherlands
Ronald Boumans is a senior regulatory consultant at Emergo with a special focus on the Medical Devices Regulation implementation. He is an executive board member of the European Association of Authorized Representatives (EAAR) and represents EAAR in the New Eudamed Steering Committee. Ronald is actively involved in four of the seven New Eudamed working groups. Before working for Emergo, Ronald was employed for more than a decade as a senior inspector of medical technology at the Dutch Healthcare Inspectorate, the competent authority for The Netherlands.
Trish Groves
Deputy Editor, British Medical Journal, United Kingdom
Dr Trish Groves trained in medicine and psychiatry before joining The BMJ in 1989, where she is Director of Academic Outreach and Advocacy for BMJ, Editor-in-Chief of the online only journal BMJ Open, and Honorary Deputy Editor of The BMJ. She has published widely, particularly as a coauthor of research reporting guidelines including the CONSORT 2010 statement on clinical trials https://scholar.google.com/citations?user=OMJJMOEAAAAJ&hl=en Trish is currently exploring how BMJ might help to build capabilities for health research in low and middle income countries, and is editorial lead of BMJ’s Research to Publication elearning programme for health researchers.
Marie Manley
Partner, Head of EU and UK Life Sciences (UK), Sidley Austin LLP, United Kingdom
Marie Manley leads is Partner and Head of Sidley’s UK life sciences practice. She is a distinguished thought leader and adviser on EU and UK regulatory law and acts as Chairperson of the DIA Legal Affairs Community. Marie advises clients before both national and European courts and the regulatory agencies in the UK and across Europe. She represents leading pharmaceutical and life sciences companies in litigation before the EU and English Courts, as well as before the national and EU regulatory authorities. Marie features prominently in leading bar publications. She earned a LLM from Columbia University School of Law and from Lausanne University; and a Postgraduate Diploma on EU Competition Law from King’s College.
Jennifer O'Callaghan, MPH, MSc
Clinical Data Sharing Manager, Wellcome Trust, United Kingdom
Jen is the Clinical Data Sharing Manager for the Wellcome Trust and works on a wide range of data sharing projects with stakeholders from academia and industry. Jen is responsible for providing the independent review panel secretariat for clinicalstudydatarequest.com which enables researchers to access trial data from 13 leading pharma companies.
Erik Vollebregt, JD, LLM
Partner, AXON Lawyers, Netherlands
Erik's practice focuses on (medical) technology, pharmaceuticals, healthcare and life sciences in regulatory matters and he is active in litigation, commercial and transactional work in all of these fields.
Rebecca Williams, PharmD, MPH
Senior Clinical Trials Subject Matter Expert, Essex, Part of Emmes Group, United States
Rebecca Williams, PharmD, MPH, is a Clinical Trials Subject Matter Expert with Essex, Part of Emmes Group. In this role she supports strategic policy and data initiatives with the National Cancer Institute’s Coordinating Center for Clinical Trials. Prior to this role she was the Acting Director of ClinicalTrials.gov at the National Library of Medicine (NLM) after having served as the Assistant Director for over a decade. She has also worked in regulatory and policy aspects of prescription drug advertising and promotion at the Food and Drug Administration and as a consultant. She received her Pharm.D. from the University of Wisconsin-Madison and MPH from Johns Hopkins Bloomberg School of Public Health.
Mats Ericson, PhD
Director Regulatory Affairs, Amgen, France
Mats is a molecular biologist by training and works as Regulatory and R&D policy director at Amgen. He has a background in academic immunology research, company-sponsored clinical development, project management and has for the last ten years been in drug regulatory affairs.
Nicole Hinton
Sr Director, Clinical Trial Transparency, Ultragenyx Pharmaceutical, United States
Nicole has over 22 years of experience in the pharmaceutical industry and has been involved with Clinical Trial Disclosure and Transparency since 2013. She is currently the Director of Clinical Trial Transparency at Ultragenyx Pharmaceuticals and oversees clinical trial registration and results disclosure, plain language summary development and redaction of clinical documents.
Noemie Manent, PharmD
TDA-CTT Operations Workstream Lead, European Medicines Agency, Netherlands
Noémie Manent is the Operations Lead in the Clinical Trial Transformation team at the European Medicines Agency, facilitating change management for member states and sponsors with the implementation of the clinical trial Regulation. She has played an essential role in the set up of structured summary results for clinical trials. Also, she has experience in the coordination of inspections for marketing authorisation application. Noemie has more than 15 years experience working in clinical R&D for small and medium enterprises in industry and academia mainly in France and the United Kingdom.
Jennifer Miller, PhD
Associate Professor of Medicine; Co-Director, Program for Biomedical Ethics, Yale School of Medicine, United States
Jennifer E. Miller, PhD, is an Assistant Professor in NYU School of Medicine and President of Bioethics International. She is also the Creator of the Good Pharma Scorecard, an index that ranks new drugs and pharmaceutical companies on their ethics and public health performance to help recognize good practices in companies, improve trustworthiness, and incentivize change where needed. Prior to joining NYU, Dr. Miller was based at Duke University and Harvard University. Dr. Miller serves on NYU’s Pharmacy and Therapeutics Committee, Stem Cell Research Oversight board, and J&J-NYU Compassionate-Use Advisory Committee (monitor).
Martin Dræbye Gantzhorn
, Horten Advokatpartnerselskab, Denmark
Martin is Sector Head of Horten's top tier Life Science & Healthcare Practice Group, which comprises a big team of dedicated lawyers advising international and national businesses on all aspects of relevance to the Life Science & Healthcare Sectors. Combining legal skills and industry knowledge, the Practice Group provides a full service offering the broadest range of commercial, data privacy, IT, IP and regulatory services to some of the leading companies in the Life Sciences & Healthcare Sectors.
Emma Du Four, MBA
Regulatory and R&D Policy Professional, -, United Kingdom
Regulatory and R&D professional with extensive experience across a network of industry, government, academic and healthcare system partners and stakeholders. Broad range of expertise in all aspects of medicines and device research and development including evidence generation, licensing, manufacturing, market access and on-market support. Specific areas of expertise include clinical trials, biologics, real world evidence, paediatric drug development, medical devices, pharmacovigilance, CMC and regulatory policy and strategy development.
Thomas Goedecke, PharmD, PhD
Senior Pharmacovigilance Specialist, European Medicines Agency, Netherlands
Since joining EMA in 2006, Thomas Goedecke has worked in all major areas of pharmacovigilance. His roles encompassed data collection and management in EudraVigilance, risk management for authorized medicines, with a focus on medication errors. Since 2015, he spearheads the implementation of the PRAC Impact Strategy,coordinating impact assessments and regulatory research for the European medicines regulatory network. He has contributed to the ENCePP Methods Guide and GVP guidelines on RMM effectiveness evaluation. Additionally, he oversees medication error reporting guidelines.
Síle Lane
Director of Campaigns and Policy, Sense about Science, United Kingdom
Síle oversees Sense about Science’s campaigns work. This includes the libel reform campaign which led to the Defamation Act 2013, the Ask for Evidence campaign which encourages everyone to ask for evidence for every claim they see and the AllTrials campaign for clinical trial transparency. In September, Síle gave a TEDxMadrid talk on the need for global trial transparency. Síle organised the Big Libel Gig at the Palace Theatre in 2010, appears regularly in the media, chairs debates with leading scientists and commentators, gives evidence to parliament and spends a lot of time helping researchers, regulators, policy makers, companies and NGOs to talk about science and evidence openly, humanly and without stigma and intimidation.
John Poland, PhD
Regulatory Affairs Consultant, Association of Clinical Research Organizations (ACRO), United Kingdom
John has worked in Regulatory Affairs since 1979 until retiring from Covance, where he had global responsibility for regulatory policy and compliance, in March 2015. John is a former chair of the ACRO European Scientific and Regulatory Committee and now acts as a consultant to ACRO.
Richard Stephens, MA
Past Chair, Consumer Forum, National Cancer Research Institute (NCRI), United Kingdom
Richard Stephens has survived two cancers, a heart emergency, and continued co-morbidities and late effects. He has participated in four interventional studies and nine others. He chaired the NCRI Consumer Forum 2012-2019 and now chairs BBMRI-ERIC’s Stakeholder Forum (Europe’s biobanking infrastructure). He sits on strategic groups for NIHR, NHS England, PHE, Genomics England, Cancer Research UK and the ABPI, and works with industry and with patient groups in Canada and Europe. Richard co-authored the UK Cancer Strategy, helped found the AllTrials campaign and useMYdata movement, and is the patient lead for the UK’s Living With And Beyond Cancer research priorities. He is also co-edits the Journal of Research Involvement and Engagement.
Virginia Acha, PhD, MSc
AVP, Global Regulatory Policy, Merck Sharp & Dohme LLC, 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 joined MSD in 2017 to lead regulatory policy efforts ex-US for innovation that leads to better treatment for patients globally. Since 2020 this scope has expanded, as Ginny now leads the talented and experienced Global Regulatory Policy and Intelligence team for MSD. Her work has regularly focused on policy shocks that challenge innovation and access to novel therapies for patients, including global and industry-wide policy work on BREXIT, COVID-19 and now the R&D impacts of the Inflation Reduction Act.
Janice Branson, MSc
VP Head of Statistics, Immunology & Dermatology Unit, Novartis Pharma AG, Switzerland
Janice Branson is the Statistics Development Head for Immunology and Dermatology in Clinical Development & Analytics at Novartis. She holds a MSc. in Biometry from University of Reading and a BSc. in Mathematics, Statistics and Computer Science. After post graduate studies at University of Reading U.K., Janice joined Pfizer in UK. In 2001. Janice moved to Novartis, Basel taking on a role in the statistics group supporting early development. Over the last years Janice has had increasing roles of responsibility and along with leading the global statistics group for the Immunology and Dermatology Franchise, since early 2013 Janice is the Statistics lead across Novartis on clinical trial data transparency and implementation of Policy 0070.
Christian Fulda
Lawyer, Jones Day, Germany
Dr. Christian Fulda focuses his practice on the life sciences industry. He has broad experience covering the legal issues that these heavily regulated industries face, including product development and issues related to securing IP rights; entering into development agreements and setting up clinical trials; advising on regulatory questions regarding marketing authorizations, including disclosure of data, and reimbursement; negotiating manufacturing and distribution and related agreements; and advising on day-to-day operations, including advertising regulation, health care compliance, and product liability issues. In addition, Christian has an extensive track record in global dispute matters.
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