VCLS Webinar Series
Preparing Clinical and Product Development Documentation for Public Release:
The Implementation of EMA’s Transparency Policies
EMA’s transparency policies into practice (policies 0043: ‘access to documents’ and 0070: ‘publication of clinical data for medicinal products for human use’)
Presenters: Frédéric Pailloux, Senior Director & Elisabeth Garrison, Senior Regulatory Scientist
The European Medicines Agency’s initiatives to increase the transparency of clinical trials, and provide an access to summary study results and raw data from trials sponsored by the pharmaceutical industry, as well as any document submitted to the EMA throughout development, remain the subject of an intense public debate.
With a several years of experience of policy 0043, and just a few months with policy 0070, this webinar will focus on the practical implementation for drug developers, and highlight Confidential Commercial Information (CCI) and Protection of Personal Data (PPD) mechanisms, which are governing the nature of the information for disclosure.
Key learning objectives:
Understand the objectives and content of EMA policies 0043 & 0070, as well as the scope of the obligations of disclosure for pharmaceutical companies;
Understand the concepts of Confidential Commercial Information (CCI) and Protection of Personal Data (PPD), and how these have been at the heart of recent cases;
Learn how these policies are implemented, and anticipate how your organization may be impacted.
Frédéric Pailloux and Elisabeth Garrison will share VCLS experience on interacting with the EMA about the public disclosure of development documentation.
About the presenters:
Frédéric Pailloux, is Senior Director at VCLS, in charge of design and implementation of global regulatory strategies for the development, evaluation and marketing of small molecules and biologics.
Elisabeth Garrison, is Senior Regulatory Scientist at VCLS, specialized in the management of clinical data.
VCLS supports life science companies and engages in communication with regulators and payers to develop, register and launch innovative health products in global markets.