Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application is a seminar that covers topics such as:

• 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

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application brings together 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.

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application will be held on 07-08 Feb 2024.