Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

  • 19-20 Jun 2024
  • 02-03 Oct 2024
  • Webinar

Description

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 19-20 Jun 2024.

More Details

Prices:
549-649 Pound Sterling (Estimated)
Organizer:
Management Forum
Website:

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Important

Please, check "Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Medical device, Medical laboratories, Pharma
Science: Life Sciences & Biology
Technology: Biotechnology

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