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

• 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

• 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