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Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application


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Who should attend?

Senior R&D Managers Members of Medical Science Clinical Trial Departments Medical Writers Regulatory Affairs personnel All those interested in teh CTD Document Clinical Overview and Summary and its place in the evolving clinical, safety and regulatory processes

Details

COURSE OVERVIEW

The Common Technical Document (CTD) Guideline is the obligatory format in the EU and most territories worldwide for registration applications.

This meeting will present the regulatory guidelines and requirements, discuss practical approaches to developing the content and preparation of the Clinical Overview and Clinical Summaries (module 2) and provide an update on the latest developments. Associated documents will also be discussed, such as the Risk Management Plan and Summary of Product Characteristics.

WHY YOU SHOULD ATTEND

  • Issues to be addressed during this meeting include:-
  • Meeting Regulators’ expections
  • Writing clinical documents for global submissions
  • Preparing separate integrated summaries of efficacy and safety for FDA
  • Content of generic applications, OTC switches and line extensions
  • Working with contract writing resource at home and abroad
  • Writing a Risk Management Plan that is consistent with the CTD
  • The place of the Clinical Overview and Summary in lifecycle knowledge from initial IB to PSUR, and how they support the changing SmPC

WHO SHOULD ATTEND

  • Senior R&D Managers
  • Members of Medical Science Clinical Trial Departments
  • Medical Writers
  • Regulatory Affairs personnel
  • All those interested in teh CTD Document
  • Clinical Overview and Summary and its place in the evolving clinical, safety and regulatory processes

Prices

GBP EUR USD Standard 699 979 1090 Excluding VAT @ 20.00%

Contact

Leigh White
info@management-forum.co.uk

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