Archives: Agenda

• Establish quality benchmarks and standards to ensure vendors meet the specific needs of clinical trial protocols
• Conduct regular audits, reviews, and KPI assessments to track vendor performance
• Validate vendor adherence to regulations to minimize risks and preserve the integrity of data

• Familiarize with the major revisions and updates in ICH E6R3 guidelines compared to previous versions
• Adopt standardized documentation practices to ensure consistency and compliance with ICH E6R3
• Training and Capacity Building

• Requirements for Sponsors to Prepare for a Clinical Trial Application (CTA) Submission to the EMA
• Clinical Considerations in Biosimilar Development
• Shelf-life Estimation for Investigational Products in Development

• Clearly define requirements to outline specific needs and expectations
• Evaluate Cost vs. Value: Look beyond price

• Opportunities and challenges of conducting clinical trials in Asia: Benefits and factors to consider when selecting Asian nations as trial locations
• How different notified bodies and their regulations present challenges to our clinical execution strategies
• Grasping the distinct regulatory frameworks and prerequisites for clinical trials

• As a small biotech, is it beneficial to work with a smaller CRO or a large global CRO?
• Addressing clinical development planning and strategic decision making with limited resources
• Overcoming hurdles and sharing best practice to successfully outsource trial