概要

Join us to deliberate the latest challenges and opportunities resulting from EMA, Health Canada and National Institutes of Health data disclosure & transparency policies, and gain insights on different approaches to navigate and comply with global disclosure and transparency requirements for medicinal products and medical devices.

We will also discuss the impact of the EU General Data Protection Regulation (GDPR) on data sharing; various strategies for preparing for the implementation of the EU Clinical Trials Regulation; the impact of Brexit on MHRA and disclosure requirements; how new ICMJE data sharing requirements are being implemented; what approaches sponsors are taking for redaction and anonymization; and updates on sponsor compliance.

This 2019 Conference builds on prior conference discussions and leverages learnings from Regulators and international experts in the field.

特集トピック

Legal Requirements for disclosure of Clinical Research Information
EU Clinical Trial Regulation requirements for trial results summaries for laypersons
Clinical Trial Disclosure and Transparency Requirements in the Upcoming EU Medical Device Regulation
Legal impact of the EU General Data Protection Regulation (GDPR) on data sharing
Operationalizing ICMJE’s data sharing requirement - How sponsors are approaching data sharing/Experience to date from the ICMJE
Latest update from ClinicalTrials.gov
Planning for submission of clinical documents to Health Canada and EMA
Understanding approaches sponsors are taking on redaction and anonymization
Impact of Brexit on MHRA and clinical trial disclosure requirements

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Exhibits

Exhibits

参加対象

Professionals and experts from areas affected by public clinical trial disclosure requirements across drug and medical device development (regulatory affairs, scientific affairs, medical writing, clinical operations, medical communication, biostatisticians/biometrics, project management, medical affairs, legal, patent departments, etc.)
Consultants, CROs and companies that offer services for submitting to clinical trial registries, publication planning and medical writing
Patient organisations
Regulatory agencies
Academic institutions

学習目的

Learn about the latest developments relating to EMA’s Clinical Data Publication Policy 0070, Health Canada’s Clinical Data Publication Policy, ICMJE Data Sharing Statement Requirement, EU MDR, EU GDPR, Brexit and MHRA, and ClinicalTrials.gov from regulators, legal experts as well as industry experts.
Benefit from the various perspectives on regulatory, legal aspects and practical challenges from large to smaller sponsor organisations
Leverage best practices on the practical implementation through case studies by the exchanging of views between regulators, industry, patients, academia and other stakeholders
Use a unique opportunity for networking and asking questions to your own specific situation and area of responsibility

Short Course or Primer

To keep you at the forefront.

2019年12月03日 (火)

The Evolving Disclosure/Transparency Landscape (Workshop):

2019年12月03日 (火)

The Evolving Disclosure/Transparency Landscape (Workshop):

プログラム委員会

Julie Holtzople President
Holtzople Consulting, United States
Merete Joergensen, MBA, MSc Clinical Disclosure and Transparency Expert
Merete-J Consulting, Denmark
Scott Feiner Senior Manager, Trial Disclosure
AbbVie, United States
Robert Paarlberg, MS Principal
Paarlberg & Associates LLC, United States
Matthias Zerm, PhD Lead Expert, Clinical Trial Disclosure and R&D Processes
Merz Pharmaceuticals GmbH, Germany