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Virtual

Dec 05, 2023 1:15 PM - Dec 07, 2023 7:00 PM

(Central Europe Standard Time)

DIA Global Clinical Trial Disclosure and Data Transparency Conference

This virtual live conference is a must-attend for anyone involved in clinical trials!

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, Trial 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.

Robert  Paarlberg, MS

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.

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.

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.

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.

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.

Francine  Lane, MBA

Francine Lane, MBA

Senior Director of Product Management, Citeline, United States

Francine Lane is the VP of Global Transparency at TrialScope and the Chair of the DIA Clinical Trial Disclosure Community. In her day job, Francine is responsible for helping TrialScope customers meet and exceed current disclosure expectations globally, giving them the tools they need to meet all the requirements in this evolving industry. Francine also dedicates her time building relationships with external stakeholders – including sponsors, investigators, regulators, and transparency and patient advocates – to help align the goals and expectations of these groups, as well as help identify more consistent ways sponsors can meet industry standards. Prior to her current role, Francine served as Director of Product Management at TrialScope.

Polyana  Bastos

Polyana Bastos

Senior Legal Counsel, Switzerland

Clive  Collett

Clive Collett

Interim Head of Policy and Engagement at the HRA, Health Research Authority, United Kingdom

Clive Collett is the Head of Policy & Engagement within the Health Research Authority’s Policy & Partnerships Directorate. He has over 25 years of experience of research regulation and research ethics committees within the NHS. He is currently involved in the update to the UK’s Clinical Trials Regulations, including the introduction of new research transparency requirements. He has a biology degree, PgDip in Healthcare Ethics and an MA in Medical Ethics & Law. He is a lay member of the Ministry of Defence Research Ethics Committee (MODREC).

Caroline  Correas, MA

Caroline Correas, MA

Associate Director, Global Regulatory Policy , Switzerland

Caroline is Associate Director in Global Regulatory Policy at Bristol Myers Squibb, based in Switzerland. She holds a Masters Degree in Political Sciences from Sciences Po Paris with a specialization in European Law. She has been working in the pharmaceutical industry for the past ten years. She has been working on preparing her organization and the industry in general for the implementation of the Clinical Trials Regulation since 2017. In particular, she has been leading the industry's efforts relevant to transitioning clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation since 2021, through cross-trade associations (representing big and small companies, commercial & academic sponsors) advocacy activities.

Anna  Fine, PharmD, MS

Anna Fine, PharmD, MS

Interim Director for ClinicalTrials.gov, National Institutes of Health (NIH), United States

Dr. Anna M. Fine joined the National Library of Medicine, NIH in 2018 and is Acting Director of CinicalTrials.gov. She leads the scientific, policy, regulatory and outreach activities related to the operation of ClinicalTrials.gov, including the modernization initiative. Her previous experience includes over a decade of service in stakeholder engagement, adverse drug event reporting, and supervisory roles at the U.S. Food and Drug Administration. Prior to that, she was Chief of Pharmacy Services at Hanscom Air Force Base in Massachusetts. Dr. Fine has a PharmD from Northeastern Univ. and an MS in psychopharmacology from William James College. She completed a postgraduate year two drug information residency at Stanford Hospital.

Boris  Grimm

Boris Grimm

Chapter Head and Capability Owner of Clinical Trial Transparency and Data Sharin, Boehringer Ingelheim, Germany

Boris Grimm joined Boehringer Ingelheim’s department for Biostatistics and Data Science in 2013. From 2014 to 2016, he took an active role in developing first-wave de-identification processes for BI’s Data Transparency Initiative and putting them into production. As a Senior Statistical Programmer he has provided many contributions to critical trial- and project activities across various Therapeutic Areas and submissions. In 2020 Boris took over the role as Head of Global Clinical Trial Disclosure & Data Transparency. Beginning of 2022 he stepped into the role of a Chapter Head and Capability Owner of Clinical Trial Transparency and Data Sharing. Since 2016 he acts as a co-chair for the PHUSE SDE in Germany / EMEA region.

Andre  Molgat, PhD

Andre Molgat, PhD

Head of Operations, Public Release of Clinical Information, Health Canada, Canada

André Molgat is the Head of Operations for Health Canada's Public Release of Clinical Information initiative. He was previously a core member of the team responsible for the initiative's regulatory and policy development. André has a PhD in biochemistry and post-doctoral training in biochemistry and stem cell biology.

Laura  Pioppo, MSc

Laura Pioppo, MSc

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.

Kristof  Van Quathem

Kristof Van Quathem

Data Protection Advisor, Covington and Burling, Belgium

Monique  Al, PhD

Monique Al, PhD

Special advisor CCMO, Central Committee on Research Involving Human Subjects (CCMO), Netherlands

Monique Al is currently special advisor at the Central Committee on Research Involving Human Subjects (CCMO) in The Netherlands. Since May 2023 she is the vice-chair of the Clinical Trial Coordination Group. She is the lead of the CTCG ethics advisory group. Her background is Clinical Nutrition with a PhD in Human Biology. She has worked for several nutritional and pharmaceutical companies in the field of clinical research before she started in 2001 as a scientific staff member at the CCMO.

Thomas  Brookland, MSc

Thomas Brookland, MSc

EU Data and AI Policy Lead, F. Hoffmann-La Roche Ltd, Switzerland

Thomas (Tom) Brookland has worked in the Pharma industry for the last 15 years, combining interests in regulatory science, health technology and policy research. He joined Hoffmann La Roche in 2008 and in this time has held multiple roles within regulatory product development across molecules and therapeutic areas, in addition to globally and regionally focused policy lead roles in the emerging areas of RWD/RWE, big data, digital health and AI/ML. His current work and passion is focused on strategy and external engagement in the European policy landscape for data, digital and AI, supporting the development of new policy options as the convergence of medical knowledge, technology and data science is revolutionising patient care.

Anne-Sophie  Henry-Eude, PharmD

Anne-Sophie Henry-Eude, PharmD

Head of Documents Access and Publication Department, European Medicines Agency, Netherlands

Dr Anne-Sophie Henry-Eude has a degree in pharmacy from the University of Lille in France and postgraduate degrees in Regulatory Affairs and in Pharmacovigilance & Pharmacoepidemiology. She worked in the pharmaceutical industry before joining EMA as product team leader for anti-infectives and later as paediatric coordinator in the HIV and vaccines field. In 2013 she put in place a Service to centralised activities linked to access to documents (Policy 0043) and later Clinical Data Publication (Policy 0070). Since 2021, she is Head of Documents Access & Publication, a Department, which manages transparency activities at EMA.

Julia Anna  Hild

Julia Anna Hild

Global Clinical Development & Operations, Boehringer Ingelheim Pharma GmbH & Co.KG, Germany

Julia A Hild (formerly Gindele) holds a PhD in Human Biology from Ulm University and has a background in pharmaceutical biology and biological sciences. In 2020, she joined Boehringer Ingelheim as a Medical Writer, where she has focused on lay language writing. Julia further honed her skills by completing a plain language writing degree. She specializes in developing lay language documents and patient-facing material across all therapeutic areas. She supports the development of lay summaries, develops scripts and storyboards for lay summary videos, and videos to support trial recruitment. Moreover, she is involved in the development of further lay language documents such as lay protocol synopses, comics, and Informed Consent Forms.

Marianne  Lunzer, DrMed

Marianne Lunzer, DrMed

Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care, AGES, Austria

Marianne is a medical doctor by training and joined AGES in 2008 as a pharmacovigilance assessor. She was an alternate PRAC member between 2015 and 2017. In 2017, she joined the clinical trial unit at AGES as a safety assessor and has since been part of the Clinical Trials Facilitation and Coordination Group (CTFG) group. Since 2022 she is chairing the group now called Clinical trials coordination group (CTCG). Marianne contributed to the CTFG best practice guidelines for safety assessors for clinical trials and is a member of the drafting team for the Commission implementing regulation for the cooperation in safety assessment of clinical trials.

Adian  Maloney, MS, RAC

Adian Maloney, MS, RAC

Data Disclosure & Transparency Associate, BeiGene, United States

Adian Talib holds a Master's of Science in Biochemistry with a minor emphasis on Pharmaceutical Law. She has more six years of experience in Clinical Research spreading from site level monitoring to industry. She currently holds a position with BeiGene as a data disclosure associate. Adian is skilled in registering drug studies and posting results on ClinicalTrials.gov, EudraCT, CTIS, jRCT, and ChinaDrugTrials. Integrating companies into adapting international regulations for registrations and ensuring transparency among clinical trials is a continuous goal of Adian's.

Jeppe G.  Manuel, MLIS

Jeppe G. Manuel, MLIS

Principal R&D Data Privacy Specialist, Novo Nordisk, Denmark

Jeppe joined Novo Nordisk in 2015 and prior to his current role worked as a specialist in Clinical Reporting and Disclosure. He has 15+ years of experience from the pharmaceutical industry, primarily from Regulatory and Clinical working with Enterprise Content Management, Digitalisation, Information Management and Data Privacy. He was responsible for implementing EMA Policy 070 in Novo Nordisk. Since 2018 he has been the Principal R&D Data privacy Specialist, responsible for driving and aligning Novo Nordisk’s privacy by design/default efforts across the global R&D organisation. He was the track lead for TransCelerate’s “Privacy framework for clinical data reuse”. Jeppe holds a master’s degree in Library and Information Science.

Catherine  Brown

Catherine Brown

Clinical Trial Transparency and Disclosure Manager, Pfizer Inc., United States

Catherine has 9 years of experience in the transparency and disclosure space. As an anonymization specialist for contract research organizations, she supported the anonymization of protected data for several mid-sized to top tier pharmaceutical clients. In 2021, Catherine joined Pfizer as a Clinical Trial Transparency and Disclosure Manager and oversees the delivery of anonymized clinical documents prepared for Health Canada Public Release of Clinical Information, European Medicines Agency Policy 0070 and other global regulations.

Gabriella  Di Matteo

Gabriella Di Matteo

Director CTRO Team Manager, Pfizer, Belgium

Working in Early Clinical Research for more than 25 years, and leading the implementation of the CT Directive and Belgian law on Clinical Trials for the Pfizer Clinical Research Unit (Brussels) as Regulatory Manager. Member of Pfizer internal workstreams on EU CTR and active tester of the portal since UAT 1 in early 2016. Currently Global Clinical Trial Application Submission Manager in Pfizer Global Regulatory Operations, managing submissions in various European countries as well as outside Europe. Strong advocate of the EU CTR and its portal.

Julie G. Holtzople

Julie G. Holtzople

Senior Director Clinical Transparency and Data Sharing , AstraZeneca, United States

Julie Holtzople is the Sr. Director of Clinical Transparency & Data Sharing for AstraZeneca and co-lead of the CREG CTT group. Julie received her Bachelors of Science in Business Administration at Virginia Polytechnic Institute. Julie has been with AstraZeneca for 14 years. Prior to her time in AstraZeneca Julie was a management consultant in health care. Today, Julie if focused on the implementation and delivery of new transparency policies, regulations, tools and the general best practices as they emerge across the industry. As part of her role Julie is actively involved in several industry organizations focused on establishing best practices in Clinical Trial Transparency.

Mary Lynn  Mercado, PhD

Mary Lynn Mercado, PhD

Senior Group Head Regulatory Writing, Novartis Pharmaceuticals Corporation, United States

Mary Lynn Mercado is a US Group Head of Regulatory Medical Writing, Pharma at Novartis Pharmaceuticals Corporation. She has over 10 years of experience in the biopharmaceutical industry in Medical Writing, during which she has supported submissions across multiple therapeutic areas. On the Clinical electronic Structured Harmonised Protocol (CeSHarP) M11 EWG, Mary Lynn is the Deputy Topic Lead for PhRMA. She participates in the TransCelerate Clinical Content & Reuse (CC&R) workstream, where she is the lead for Strategic Engagement. Additionally, Mary Lynn has a PhD in Pharmacology and over 10 years of experience in Neuroscience research and drug discovery.

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.

Raquel  Vaquer Pérez

Raquel Vaquer Pérez

EU CTR implementation lead, Bristol-Myers Squibb, Belgium

Wendy M Wimmer, MS

Wendy M Wimmer, MS

Director, Clinical Data Disclosure and Transparency, Merck & Co., Inc., United States

Wendy Wimmer is a Director in the Clinical Data Disclosure & Transparency department at Merck Sharp & Dohme. She has over 25 years of clinical research experience and over the last 6 years has created and currently manages a centralized document transparency functional area for her company. Most recently, she has been responsible for the implementation of the transparency processes accompanying the initiation of the EU Clinical Trial Regulation.

Chris  Bamford

Chris Bamford

Director, Regulatory Affairs, IQVIA Ltd, United Kingdom

Chris has a PhD in molecular biology and has over 20 years of experience of working in clinical trials, the last 15 years with Quintiles and IQVIA. He has represented the IQVIA Regulatory Affairs team in EMA stakeholder groups regarding the development of the EU CTIS since 2014, contributing from the perspective of both sponsors and CROs on behalf of the Association of CROs. Chris has also led IQVIA’s implementation of the new Regulation throughout this time, overseeing the more than 100 new clinical trial applications IQVIA has submitted in CTIS.

Stéphanie   Kromar

Stéphanie Kromar

Senior Regulatory Affairs Manager, European Organisation for Research and Treatment of Cancer (EORTC) , Belgium

Stéphanie Kromar joined the European Organisation For Research And Treatment Of Cancer (EORTC) in 2013. Since September 2022, she is the Head of the Regulatory Affairs department. She has experience in the preparation, submission, and follow-up of Clinical Trials Applications from the development until the end of the trial, on complex trial designs and she provides regulatory advice. She has an in-depth knowledge of the CT Regulation, was involved in the CTIS project almost since the beginning and she also took part to the review of the CTIS training material.

Fatima  Pimentel

Fatima Pimentel

Director, Regulatory Consulting, Syneos Health, Spain

Fatima Pimentel joined Syneos Health in 2021 as an Associate Director, Site Start-Up & Regulatory and is also responsible for the training and development of the new CTIS Portal Team. She worked as a Regulator in the Portuguese Agency INFARMED, I.P, between 2005-2021 in the Clinical Trial Unit, as a senior CT coordinator. Fatima was part of several EMA CT groups as well as CTFG. Fátima studied Industrial Pharmacy and obtained a POS-degree in Clinical trials Monitoring. Joining the EMA-CTIS project almost from start as a MS Product Owner and master trainer. Currently she is a trainer in the EMA/DIA CTIS sponsor trainings.

Seán  Kilbride, PhD

Seán Kilbride, PhD

Director, Regulatory Affairs, Regeneron Ireland DAC, Ireland

Seán Kilbride has worked at the EU headquarters for Regeneron, based in Dublin, Ireland for over 5 years and led the preparation of Regeneron’s new procedures for EU CTR in addition to providing regulatory leadership on development programs for new medicinal products. Seán previously worked as a Clinical Assessor at the HPRA where he contributed to the development of EU CTR guidance at the European Commission Expert Group on Clinical Trials as well as the Heads of Medicines Agency’s Clinical Trials Facilitation Group (CTFG), where he shared the CTFG Secretariat role. Seán holds a PhD in Neuroscience from Trinity College Dublin.

Jan Willem  Kleinovink

Jan Willem Kleinovink

Scientific staff / Validation team lead / CTIS Support, Central Committee on Research Involving Human Subjects (CCMO), Netherlands

Jan Willem Kleinovink joined CCMO, the competent authority on clinical trials in the Netherlands, in 2020 as a clinical assessor. Currently, he is team lead for validation of CTR applications, and provides support and training on CTIS applications to authority and sponsor users. Earlier, he obtained his PhD in immuno-oncology and worked as post-doctoral researcher.

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.

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