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 Principal
Paarlberg & Associates LLC, United States
Merete Joergensen, MBA, MSc Clinical Disclosure and Transparency Expert
Merete-J Consulting, Denmark
Matthias Zerm, PhD Lead Expert, Clinical Trial Disclosure and R&D Processes
Merz Therapeutics GmbH, Germany
Julie Holtzople President
Holtzople Consulting, United States

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The Evolution of Policy 0070: EMA Clinical Data Publication