Developments in relation to implementation of EMAs Clinical Data Publication Policy 0070, NIH Final Rule for FDAAA, ICMJE Data Sharing Requirement, EU GDPR, EU Medical Device Regulation, Health Canada’s draft guidance on Public Release of Clinical Information, and FDAs new initiatives on sharing clinical documents publicly:

• Latest updates from EMA and NIH (on ClinicalTrials.gov)
• Best practices for operationalizing EMA’s Clinical Data Publication Policy 0070 submissions including risk assessments
• Compare and contrast qualitative and quantitative data anonymisation techniques for sharing of individual participant data
• Utility of redacted/anonymized clinical data
• Planning for submissions to ClinicalTrials.gov
• Planning and thinking ahead for submission of documents for EMAs Clinical Data Publications Policy 0070 and documents for inclusion of results submission for ClinicalTrials.gov
• Understand the legal impact of the EU General Data Protection Regulation (GDPR) on data sharing
• Clinical trial disclosure and transparency requirements in the upcoming EU Medical Device Regulation
• Compare and contrast EMA, FDA and Health Canada’s clinical data publication policies
• Operationalizing ICMJE’s new data sharing statement requirement – How Sponsors are Approaching this new requirement/Experience to date from the ICMJE
• Experiences with FDA’s Pilot Clinical Data Publication Project
• Strategies for preparing for implementation of the EU Clinical Trials Regulation
• Company strategies regarding returning trial results to participants and meeting the EU
• Clinical Trial Regulation requirements for trial results summaries for laypersons

• 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 EMA Clinical Data Publication Policy 0070, FDAAA Final Rule, ICMJE Data Sharing Statement Requirement, EU GDPR, Health Canada’s new clinical publication regulation and EU MDR from regulators, legal experts as well as industry experts
• 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
• Use of the option for networking and asking questions to your own specific situation and area of responsibility