Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

The Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application provides essential training on developing clinical overviews and summaries in accordance with the Common Technical Document guidelines, equipping attendees with practical skills for global regulatory submissions.

Topics

• Meeting regulators’ expectations
• Common Technical Document guideline
• Preparation of summaries of efficacy and safety for FDA
• Writing clinical documents for global submissions
• Generic applications and line extensions
• Submissions in Korea, Taiwan, Russia and China and other International Markets
• Working with contract writing resource at home and abroad
• Document Writing
• Risk Management Plan writing and keeping it consistent with the CTD
• Avoiding Errors and Ensuring Quality
• The Clinical Overview and Summary place in lifecycle knowledge from initial IB to PSUR, and how they support the changing SmPC

Who should Attend

Medical Science Clinical Trial Departments, Senior R&D Managers, Regulatory Affairs personnel and Medical Writers and others interested in the Common Technical Document Clinical Overview and Summary and in the regulatory approval process.