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Virtual

Nov 29, 2021 2:00 PM - Dec 01, 2021 7:00 PM

(Central Europe Standard Time)

Clinical Trial Disclosure & Data Transparency Conference

Evolving Requirements and New Challenges

Speakers

Merete  Joergensen, MBA, MSc

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.

Scott  Feiner

Scott Feiner

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

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

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

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

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

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

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.

Ulrike  Fischer

Ulrike Fischer

Medical Writer - Statistical Programmer, Staburo GmbH, Germany

Hitesh  Manchanda, MPharm

Hitesh Manchanda, MPharm

Associate Director, Syneos Health, India

Kathleen  Ormiston, MS

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.

Rose-Marie  Swallow

Rose-Marie Swallow

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

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.

Natacha  Bolanos

Natacha Bolanos

Global Alliances Manager , Lymphoma Coalition , France

Celine  Bourguignon, PharmD

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

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.

Ingrid  Klingmann

Ingrid Klingmann

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.

Britta  Lang

Britta Lang

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

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

Zsofia Bakonyi, MA

Senior Manager Partnerships, EFPIA, Belgium

Carine  Cochereau

Carine Cochereau

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

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

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

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

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.

Laura  Pioppo

Laura Pioppo

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

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.

Joyce  Swart

Joyce Swart

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.

Representative Invited

Representative Invited

MDS Pharma Services

Erin  McDonagh

Erin McDonagh

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

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

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

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

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

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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