The Clinical Overview and Clinical Summary - Creating an Effective Marketing Authorisation Application
23rd September 2013

The Clinical Overview and Clinical Summary - Creating an Effective Marketing Authorisation Application

This meeting will look at the latest guidance on how to prepare the Clinical Overview and Summary in accordance with regulatory expectations and to comply with the requirements of the Common Technical Document.

Issues to be addressed during the meeting will include:

• A review of the Common Technical Document guideline
• Meeting regulators' expectations
• Writing clinical documents for global submissions
• Preparing separate integrated summaries of efficacy and safety for FDA
• Submissions in International Markets
• Content of generic applications and line extensions
• Document Writing including Practical Considerations
• Writing for success in a team environment
• Working with contract writing resource at home and abroad
• Ensuring Quality and Avoiding Errors
• Writing a Risk Management Plan that is consistent with the CTD
• Impact of 2012 EU Pharmacovigilance Requirements
• The place of the Clinical Overview and Summary in lifecycle knowledge from initial IB to PSUR and how they support the changing SmPC

If you have any queries please click here to contact Zena Singer

Expected Number of Attendees

0-50

View Conference Website: The Clinical Overview and Clinical Summary - Creating an Effective Marketing Authorisation Application

Price of Attendance

£575 + VAT

Brochure

View Event Brochure

Location

The Rembrandt Hotel
11 Thurloe Place
London
United Kingdom
SW7 2RS