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.
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.
Robert Paarlberg, MS
Principal, 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.
Nate Root, MSc
Associate Director, Disclosure and Transparency, Ionis Pharmaceuticals, United States
Nate is Disclosure and Transparency professional with over 7 years of experience in the environment, working with CROs, Big Pharma, Non-Profit, and Small Biotech, as well as being a member of the DIA Disclosure Community Core Team, PhUSE CTD working group, Co-Author of Disclosure and Transparency white papers, and creator of the West Coast Disclosure and Transparency Community. At Ionis, Nate leads the Transparency Department and also manages Regulatory Policy.
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.
Thomas Schindler, PhD
Director Global Regulatory Affairs - Regulatory Operations, BioNTech SE, 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.
Sameer Sharma, MPharm
Associate Director, Clinical Trial Transparency, Merck KGaA, Germany
Sameer Sharma works as a Clinical Trial Transparency Manager at Merck KGaA, Darmstadt, Germany since 2015. He has 10+ years of experience in the Clinical Trial Transparency and Medical Writing domain. At Merck, he is responsible for setting up the processes and overseeing redactions and anonymizations as per worldwide redaction regulations not limited to EMA policy 0070, Health Canada-PRCI, Japan PMDA, EMA Policy 0043, and ad hoc redaction requests. He holds a Masters in Pharmaceutical science and a registered Pharmacist.
Susan Bhatti, PhD
Director EU Global Regulatory and Scientific Policy, Global Regulatory Affairs, Merck Healthcare, Netherlands
Susan Bhatti has been working in Regulatory Affairs in the pharmaceutical and clinical research industry for more than 25 years. At Merck BV she is Director EU Global Regulatory and Scientific Policy and is responsible for supporting the development of regulatory and scientific policies as well as responding to regulatory & legislative issues that impact product development. She is co-chair of the Clinical Research Expert Group at EFPIA as well as a co-chairing subgroup focussed on patient engagement. She is currently co-leading a multi-stakeholder initiative on cross-border access to clinical trials in Europe (EU-X-CT), which is a joint undertaking by the European Forum for Good Clinical Practice and EFPIA.
Medical Writer - Statistical Programmer, Staburo GmbH, Germany
Hitesh Manchanda, MPharm
Associate Director, Syneos Health, India
Kathleen Ormiston, MS
Global Head of Trial Transparency, Sanofi US Inc, United States
Kathleen has worked in the clinical content area for over 20 years, first in medical writing, more recently clinical trial disclosure and data-sharing, in large and small companies. In her current role she oversees an international team of trial transparency managers, evolving the team and processes as disclosure and digital landscapes continue to change. Kathleen holds an MS in Science communication, as well as project management certification.
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.
Jesper Kjær, MS
Global Director for Public, Private Partnerships, Strat Ops, Global Med Affairs, Novo Nordisk, Denmark
Director of Data Analytics Centre at the Danish Medicines Agency and co-chair of HMA / EMA Big Data Steering Group. 20 years for life science experience in academia and industry. Been leading EU framework programme workpackages, IMI and TransCelerate Biopharma workstreams in the past. Currently active in development of FHIR for clinical research and use of AI/ML in life science.
Global Alliances Manager , Lymphoma Coalition , France
Celine Bourguignon, PharmD
Head Greater China and Intercontinental & Emerging Markets Regulatory Policy, GSK, Belgium
Céline Bourguignon has a track record of more than 25 years in the healthcare sector at European and international level both in the public and the private sector. Céline joined GSK in 2021 to lead the Greater China and Intercontinental & Emerging Market Regulatory Policy team. She joins from Cardinal Health where she served during the last three years as head of Quality, Regulatory and Clinical Affairs for the EMEA region, and as a member of the European Leadership team.Céline held various Chair or Vice-Chair positions within Medtech Europe (Eudamed, UDI & Supply chain, Regulatory Affairs Committee).
Juan Garcia-Burgos, MD, PhD
Head of Public and Stakeholders Engagement Department, European Medicines Agency, Netherlands
Juan García Burgos is a Qualified Medical Doctor from Autonoma University in Madrid, specialised in urology. Juan worked as a urologist surgeon at the Maranon hospital in Madrid. He joined the European Medicines Agency in 2002 and was responsible for coordinating the preparation of EU clinical guidelines for drug development. In 2005 he was appointed Head of Medical and Health Information, being directly involved in the interaction with Patients, Consumers and Healthcare Professionals' Organisations and the preparation of information on benefit-risk of medicines for lay audiences. In 2017, he was appointed Head of Public and Stakeholders Engagement Department and is Co-chair of the EMA patients’ and healthcare professionals’ working party.
Chairman, 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.
Head of Board, KKS- Network, Germany
Britta Lang holds a PhD in classics (1997) and completed 2006 her MSc in Science Communication (OPEN, UK). Here main areas of expertise have been evidence based patient information, knowledge transfer and transparency in clinical research. She was member of the Cochrane Consumer Network, acted from 2003 – 2011 as co-chair of the section ‘patient information and participation’ of the German Network for Evidence Based Medicine. She joined the EUPATI Advisory Board (2012 – 2016). 2018 she took over the lead of the Clinical Trial Unit at the University Medical Center at Freiburg, Germany. Since 2020 she is Chair of the Network of Clinical Trial Units in Germany.
Naho Yamazaki, PhD
Head of Policy and Engagement, Health Research Authority, United Kingdom
Naho is Head of Policy and Engagement at the Health Research Authority (HRA), where she is leading on a range of policy and engagement initiatives including the implementation of HRA’s Make It Public Research Transparency Strategy. She joined the HRA in Sep 2019, having worked on developing and influencing a range of health and biomedical research policy at the Wellcome Trust, NSW Ministry of Health in Australia and the UK Academy of Medical Sciences.
Zsofia Bakonyi, MA
Senior Manager Partnerships, EFPIA, Belgium
Vice President International Regulatoy Affairs, Integra Life Science, Belgium
Carine holds a Pharmacist PHD and a MBA in Industry Management. Further to 3 years of pharmaceutical and clinical activities in hospitals located in Paris, Carine started her professional career in medical device industries within Johnson & Johnson for a period of 12 years followed by 2 years within Cardinal Health and Biom’up playing different roles in Quality, Regulatory and Clinical affairs activities. Since October of 2019, Carine has been part of Integra LifeSciences as VP International Regulatory Affairs. Since 2014, Carine has been chairing the Clinical Investigation taskforce in Medtech Europe and is an active member of different groups such as the MDR, Eudamed.
Lora Killian, MBA
Clinical Trial Transparency and Disclosure Lead, Pfizer Inc, United States
Lora has 20+ years of business experience, including more than a decade of pharmaceutical industry experience. She started her career in the military serving four years of active duty in the Medical Service Corp for the U.S. Army. In her first pharmaceutical industry position, Lora served for 4 years as Director of Operations for a small medical writing company. She transitioned to Transparency and Disclosure in 2014. During her 8 years in Transparency and Disclosure, Lora has overseen delivery of 5500+ redacted and anonymized documents to support European Medicines Agency Policy 0070, Health Canada Public Release of Clinical Information, other global disclosure regulations and broader corporate transparency policies for many sponsors.
Maria Mavris, PhD
Patient Relations, European Medicines Agency, Netherlands
Maria Mavris first joined EMA as a seconded expert from a patient organisation in 2014 and then as a staff member from 2017. As part of the Public and Stakeholder Engagement department of EMA, her work focuses on involving patients all along the regulatory lifecycle of medicines with a particular focus on committee membership and scientific advice. Maria is also involved in the development of training to support patients’ representatives in EMA’s work, health technology assessment.
Ranjita Mishra, MA, MSc
Trial Transparency Senior Manager, Sanofi US, United States
Ranjita has 15 years of clinical experiences from different pharmaceutical companies. She has broad exposure to data monitoring, data management and in last 10 years, to Trial Transparency. In the ever changing landscape of Trial Transparency, her passion is to gain clear insight to Regulations & Policies that can be translated to robust processes and system enhancements. Ranjita holds a master degree in Analytical & applied Economics and another in Computer Science with specialization in Biostatistics.
Ruediger Pankow, DrSc
Regulatory Affairs Expert, CTIS SME and PO, Germany
Ruediger holds a university degree in Biology and is a clinical regulatory affairs professional with history of more than 16 years in the CRO industry at Parexel, where he last was Principal Consultant in the clinical trial regulatory services. He was involved in his company's EU Clinical Trials Regulation 536/2014 (EU CTR) readiness implementation, and has contributed for ACRO to EU CTR stakeholder activities with EU Regulators and EMA. Since 2019 he has been a sponsor product owner for ACRO in EMA's Clinical Trials Information System (CTIS) delivery project providing input on design and development of system functionalities and guidance material, and is DIA instructor of EMA's CTIS sponsor user training programme.
Scientific Administrator, CTIS expert, European Medicines Agency, Netherlands
Pharmacist with a Master degree in Pharmacovigilance, working experience at EMA in the Compliance and Inspection department, since 2016 working on the development CTIS and leading on CTIS transparency aspects, EMA liaison at the Clinical Trials Coordination Group (CTCG) and from October 2023 Programme Manager for the ACT EU initiative.
Andrea Seidel-Glaetzer, MA, RN
Head of Project Management , Coordination Centre For Clinical Trials Heidelberg (KKS), Germany
Prior to joining the University Hospital Heidelberg (KKS) 10 years ago, she gained some years’ experience in the pharmaceutical industry. KKS acts with more than 80 staff members as a kind of CRO and provides services to support mainly investigator initiated clinical trials in academic institutions, but also for smaller industries. Since March 2020 Andrea joins EMA´s Clinical Trial Information System testing as a representative of the academia on behalf of the German KKS-Network. This is an association of 26 clinical trial centers, all located at medical faculties and university hospitals with the common task to strengthen activities in clinical trials.
Clinical Disclosure Lead, Alcon Research, LLC, United States
Joyce Swart is the Clinical Disclosure Lead at Alcon Research, LLC, a major eye care device company operating in the global marketplace. For over 10 years she has been responsible for understanding disclosure requirements specific to medical device trials, developing disclosure practices and processes for companywide implementation, and overseeing the registration of medical device trials on ClinicalTrials.gov and other public registries. She is also skilled in registering drug studies and posting results on ClinicalTrials.gov and EudraCT. Joyce received her B.S. from Rutgers University, New Brunswick, New Jersey.
MDS Pharma Services
Regulatory Facilitator, University of Colorado Anschutz, United States
Mrs. McDonagh has worked in clinical research since 2012, and specifically in regulatory compliance since 2015. After beginning her career at Case Western Reserve University as a coordinator for ophthalmology studies, she first entered the world of regulatory compliance at University Hospitals of Cleveland. She now serves as the primary ClinicalTrials.gov administrator for non-oncology trials at the University of Colorado Anschutz Medical Campus, where she facilitates CTSA-funded research education and provides guidance and training related to trial registration, disclosure, and transparency. She is an active member of the Clinical Trials Registration and Results Reporting Taskforce, and co-chair of the Taskforce's Education subcommittee.
Christian Ohmann, PhD
Chair of the Network Committee of the European Infrastructure ECRIN-ERIC, Chair of the Independent Data Centre Certification Board of ECRIN ,ECRIN, Germany
Christian Ohmann has a graduation in mathematics (PhD), an interim examination in medicine and a habilitation in the field of “Theoretical Surgery”. He was the head of the Coordination Centre for Clinical Trials (KKS) at the Medical Faculty of the Heinrich Heine University Duesseldorf Germany (1999-2014) and is now retired. He is currently the German representative and Chair of the Network Committee of the new European Infrastructure ECRIN-ERIC .He has major competence and experience in the field of clinical research/clinical trials and clinical research informatics and is participant in many EU-funded projects (currnetly: EOSC-Life, HealthyCloud, BY-COVID, SIMCor)
Priya Pavithran, MSc
Senior Director, Head - Clinical Trial Transparency and Data Sharing, GSK, Belgium
Priya Pavithran is a Medical Microbiologist with nearly 20 years of industry experience. Her background is in Medical Writing and Disclosure, where she has held leadership positions in Vaccines R&D. In her current role as the Head of Clinical Trial Transparency and Data Sharing for GSK R&D globally, she is responsible for delivering on GSK’s commitment to transparency in scientific research. This includes implementing external disclosure requirements and internal policy commitments to transparency and anonymized patient-level data sharing with external researchers. She sits on the leadership team of the Office of the Chief Medical Officer, and is directly involved in driving internal disclosure strategy in GSK R&D.
Elke Stahl, PhD
Senior Expert, Clinical Trials Department, Federal Institute For Drugs and Medical Devices (BfArM), Germany
Dr. Elke Stahl, Clinical Trial Unit BfArM, Germany. Clinical Trials Senior Expert. CoChair of the Clinical Trial Facilitation Group (CTFG) till 2022. Involved in EMA’s EU CTIS groups as BfArM’s representative, National Contact Point for the CTR in Germany, representative in European Commissions CT working groups. 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.
Pierre-Frederic Omnes, MPharm
Executive Director, Life Sciences, 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.
Nick Sykes, MS
Policy Advisor, EFPIA, Belgium
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
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