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Westin Arlington

Sep 23, 2024 7:30 AM - Sep 24, 2024 3:30 PM

801 North Glebe Road, Arlington, VA 22203

Global Clinical Trial Disclosure and Data Transparency Conference

Untangle the complexities of global disclosure practices, learn about recent regulatory modernization, and discuss cross-regional strategic considerations.

Session 7: Continuation of Session 6: Results Reporting according to EU Clinical Trials Regulation

Session Chair(s)

Merete  Joergensen, MBA, MSc

Merete Joergensen, MBA, MSc

Clinical Disclosure and Transparency Expert

Merete-J Consulting, Denmark

Robert  Paarlberg, MS

Robert Paarlberg, MS

Principal

Paarlberg & Associates LLC, United States

In continuation of the Session 6 on Results Reporting via CTIS (EU), Policy 0070 (EU) and PRCI (Canada) this Session aims to provide further information such as visions for future collaboration, and mutual collaboration for ensuring harmonized documents being made available. For the panel discussion central representatives from Regulators in EU and Canada, from sponsor organizations and CROs aims to give ample opportunities for asking questions. Note: Marianne Luzner, Elizabeth Lieu, and Radu Popescu and will be participating virtually

Learning Objective :
  • Recognize the value and opportunities in visions for increased collaboration and mutual recognition of same documents for disclosure via different platforms
  • Express your views on opportunities and challenges in relation to the current experience with Policy 0070 and the PRCI
  • Ask your questions and obtain clarification from Regulators and Sponsor organizations

Speaker(s)

Honz  Slipka, MSc

Approach to Clinical Trial Transparency & Disclosure is Changing – EMA’s Policy 0070 is a Large Contributor. / Panelist.

Honz Slipka, MSc

Certara, Canada

Senior Transparency Specialist

Laura  Dodd, MSc

Redacted Document Challenges. / Panelist.

Laura Dodd, MSc

Instem, United States

Director, Clinical Trial Transparency

Francesca  Scotti

Panel Discussion: Addressing questions in relation to Requirements, Challenges & Complexities of Submitting Results Summaries, CSR’s via CTIS, Policy 0070 EU, and the PRCI (Canada)

Francesca Scotti

European Medicines Agency, Netherlands

CTIS Transparency Lead

Radu  Popescu, MD

Panel Discussion: Addressing questions in relation to Requirements, Challenges & Complexities of Submitting Results Summaries, CSR’s via CTIS, Policy 0070 EU, and the PRCI (Canada)

Radu Popescu, MD

European Medicines Agency, Netherlands

Scientific Administrator

Elizabeth  Lieu

Panel Discussion: Addressing questions in relation to Requirements, Challenges & Complexities of Submitting Results Summaries, CSR’s via CTIS, Policy 0070 EU, and the PRCI (Canada)

Elizabeth Lieu

Health Canada, Canada

Senior Regulatory Affairs Officer

Marianne  Lunzer, DrMed

Panel Discussion: Addressing questions in relation to Requirements, Challenges & Complexities of Submitting Results Summaries, CSR’s via CTIS, Policy 0070 EU, and the PRCI (Canada)

Marianne Lunzer, DrMed

AGES, Austria

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

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