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Overview

Transparency of clinical trial information is taking on new dimensions, resulting in trial sponsors and research organisations facing a host of new requirements in the EU. This 2017 Workshop leverages learnings from European and US experts as well as prior conference discussions, providing the opportunity to gain insights on how to meet new challenges. The programme is assembled around key themes:

  • Impact of the EU Clinical Trial Regulation and EMA Policy 0070 on trial disclosure business processes
  • Upcoming legal requirements related to disclosure of clinical research information for medicinal products and medical devices
  • Real-world experiences on implementation of the regulations, including fine-tuning and optimising processes to meet the requirements for disclosure, data sharing and data transparency
  • Approaches to navigating the patient and ethics committee interfaces, as well as interdepartmental discussions

Attendees will learn from case studies and the experiences of experts and their peers.

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Featured topics

Developments in relation to implementation of Policy 0070:

  • The newest on implementation guidance from EMA
  • Experience from industry on preparing documents for disclosure in relation to the Policy
  • Technical challenges in document handling
  • Facing new challenges such as preparing anonymisation reports and providing risk assessments
  • Legal aspects to consider
  • Thinking ahead when preparing documents ready for Policy 0070 disclosure

Who should attend?

  • Professionals and experts from areas affected by public disclosure 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 clinical registries, publication planning and medical writing
  • Patient organisations
  • Regulatory agencies
  • Academic institutions

Learning objectives

  • Learn about the latest developments relating to the implementation of the EU Policy 0070 from regulators as well as the industry
  • Benefit from the various perspectives on regulatory, legal aspects and practical challenges from large, mid-sized, and 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

Program Committee

  • Robert  Paarlberg, MS
    Robert Paarlberg, MS Principal
    Paarlberg & Associates LLC, United States
  • Merete  Joergensen, MBA, MSc
    Merete Joergensen, MBA, MSc Senior Trial Disclosure Director, Global Clinical Registry
    Novo Nordisk A/S, Denmark
  • Matthias  Zerm, PhD
    Matthias Zerm, PhD Lead Expert, Clinical Trial Disclosure and R&D Processes
    Merz Pharmaceuticals GmbH, Germany
  • Julie G. Holtzople
    Julie G. Holtzople Director, Clinical Trial Transparency Operations
    AstraZeneca, United States
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