7th Clinical Regulatory Medical Writing Forum 2020

Topics

• How your peers manage data sharing, redactions and the anonymization of patient data
• The new EU clinical trials regulation, the challenges of preparing lay summaries and how to stay ahead of the curve
• The challenges of preparing pediatric documentation
• How to prepare a risk management plan and safety documents for the different regional regulatory authorities
• Which tools and technologies can help expedite the medical writing process

Who should Attend

Senior attendees from pharmaceutical and biotechnology companies with responsibilities in:

• Regulatory Submissions/Documentation
• Medical/Regulatory/Scientific/Clinical/Technical Writing
• Clinical Data Transparency
• Clinical Trial Disclosure
• Clinical Operations/Development
• Clinical Documentation/Publication
• Medical/Scientific Communications
• Clinical Research
• Medical Affairs
• Medical Publication
• Global Medical Publishing
• Regulatory Affairs/Operations

As well as:

• Clinical Research Organizations
• Medical Writing Service Providers and Consultants
• Information Management Consultants
• Document Application Suppliers
• Component Authoring Software Suppliers
• Research Informatics
• ECTD Suppliers
• Bibliographic Software Suppliers
• Structured Content Software Suppliers
• Regulatory Submissions Providers