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

  • March 2020 (Not Final)
  • London, United Kingdom

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.

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

Venue

London,
United Kingdom
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Booking.com
699 Pound Sterling
Included
Management Forum
Rentalcars Savings

Past and Future Events

  • Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application 2021 - Mar 2021, London, United Kingdom (82999)
  • Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application 2020 - Mar 2020, London, United Kingdom (56276)
  • Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application 2019 - 19 Mar 2019, London, United Kingdom (17458)
  • Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application 2018 - 13 Mar 2018, 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.