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Westin Arlington

Sep 23, 2024 7:00 AM - Sep 24, 2024 7:00 PM

801 North Glebe Road, , Arlington, VA 22203 , USA

Global Clinical Trial Disclosure and Data Transparency Conference

Learn about the latest requirements in clinical trial disclosure and data transparency, share best practices, and engage in in-depth discussions on hot topics.

Early Bird Rates Expire

DAYS

HOURS

MINUTES

SECONDS

Speakers

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.

Kelly  Coulbourne, MS

Kelly Coulbourne, MS

Director, Clinical Trial Disclosure and Data Transparency, Pfizer Inc, United States

Kelly is the Director of Clinical Trial Disclosure & Data Transparency at Arena Pharmaceuticals where she is responsible for ensuring Arena remains in compliance with global clinical trial registration and results disclosure requirements, redaction of clinical documents, and plain language summary development.

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.

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.

Pritibha  Singh, MBA, MSc

Pritibha Singh, MBA, MSc

Senior Manager, Corporate Affairs Analytics & Insights, Novartis AG, Switzerland

Pritibha Singh, a leader at Novartis data42, brings 17 years of global experience spanning Switzerland, Germany, the United Kingdom, Australia, and New Zealand with extensive cross-sector experience (Tech space, Pharmaceutical, Biosimilar, Academia, FMCG, and Banking). Her expertise covers diverse therapeutic areas, including Cardiovascular, Diabetes, Neuroscience, Respiratory, Oncology, Immunology, and Hematology, with a comprehensive background in discovery, development, and late-phase. A blend of expertise in Drug Development (Psychology, Statistics, and Business). Currently pursuing a Doctorate (Dr. sc. ETH Zurich), specializing in sustainable strategies for decentralized clinical trials.

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.

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