Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

  • 31 March 2020
  • The Rembrandt Hotel, London, United Kingdom

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 in London, United Kingdom on 31 March 2020.

Venue

The Rembrandt Hotel
11 Thurloe Place,
London,
United Kingdom
  View all Hotels near Venue

More Details

699 Pound Sterling
Included
Management Forum
Rentalcars Savings

Future Events

  • Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application - 31 Mar 2020, The Rembrandt Hotel, London, United Kingdom (56276)
  • Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application - Mar 2021, London, United Kingdom (82999)

Past Events

  • Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application 2019 - 19 Mar 2019, Cavendish Hotel, London, United Kingdom (17458)
  • Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application 2018 - 13 Mar 2018, The Rembrandt Hotel, London, United Kingdom (32023)

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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