Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application 2020

March 2020 (Not Final)
London

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application 2020 might be held in London, United Kingdom in March 2020 (Not Final).

Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application 2020is 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 2020brings 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.

Venue

London,
United Kingdom
  View all Hotels near Venue
Booking.com
699 Pound Sterling
Included
Rentalcars Savings

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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