31 August – 1 September 2018 | Mumbai
Regulations and industry bodies are joining hands to simplify the process of drug development. But trials are becoming increasingly complex and the costs of drug development are increasing every day. With the demands to ensure data privacy conflict with the directive to support data transparency. In this increasingly complex world, medical writers are striving to navigate their way through complex safety and regulatory documents and are leveraging technology and RWE to drive expedited submissions.
• Risk Management: Adhering to the new EU template – Workshop
• The art of writing complex safety submission documents
• Complexities in managing regulatory documents to support expedited registration pathways
• GDPR vs EMA Policy 0070 – dealing with data transparency
• Challenges in writing submission documents for small molecules
Co-Chair: Bindu Narang Head, Regulatory Affairs and Aggregate Safety and Risk Management Practice, Sciformix
Please schedule some time to meet Bindu at he conference – we look forward to seeing you there!