DUBLIN, Jan. 15, 2016 /PRNewswire/ --
Research and Markets (http://www.researchandmarkets.com/research/p64pdn/clinical_overview) has announced the addition of the "Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application (London, UK - January 21st, 2016)" conference to their offering.
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.
Issues to be addressed during this meeting include:
- Meeting Regulators' expectation
- 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
For more information visit
Laura Wood, +353-1-481-1716, email@example.com
SOURCE Research and Markets