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Session 7: Continuation of Session 6: Results Reporting according to EU Clinical Trials Regulation
Session Chair(s)
Merete Joergensen, MBA, MSc
Clinical Disclosure and Transparency Expert
Merete-J Consulting, Denmark
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)
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
Redacted Document Challenges. / Panelist.
Laura Dodd, MSc
Instem, United States
Director, Clinical Trial Transparency
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
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
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
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