Research and Markets: The Clinical Overview and Clinical Summary - Creating an Effective Marketing Authorisation Application (Meeting, London)

Fri Jan 24, 2014 4:49am EST

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Research and Markets: The Clinical Overview and Clinical Summary - Creating an Effective Marketing Authorisation Application (Meeting, London)

Research and Markets (http://www.researchandmarkets.com/research/wtkhb4/the_clinical) has announced the addition of the "The Clinical Overview and Clinical Summary - Creating an Effective Marketing Authorisation Application (Meeting, London)" conference to their offering.

The Clinical Overview and Clinical Summary meeting will take place on the 11th March 2014 at the Rembrandt Hotel, London

The Common Technical Document 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

The

Clinical Overview and Clinical Summaries (module 2) and provide an update on the latest information and potential future 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 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, OTC switches 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

WHY YOU SHOULD ATTEND

The Common Technical Document 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 information and potential future developments. Associated documents will also be discussed, such as the Risk Management Plan and Summary of Product Characteristics.

WHO SHOULD ATTEND

Senior Research and Development Managers, members of Medical Science Clinical Trial Departments, Medical Writers, Regulatory Affairs personnel and all those interested in the Common Technical Document Clinical Overview and Summary and its place in the continuum of evolving clinical and safety knowledge about a product, and in the regulatory approval process.

DOCUMENTATION

Participants will receive a course material folder containing comprehensive documentation provided by the speaker, which will be a valuable source of reference for the future.

ATTENDANCE LIMITED - EARLY REGISTRATION RECOMMENDED

This limitation, a unique feature of all the authors seminars, will give participants the opportunity for a thorough discussion of the complex issues to be covered by the programme.

A Certificate of Attendance for Professional Development will be given to each participant who completes the course

DATES:

11 March 2014

Start: 09.30 - Finish: 17.00

REGISTRATION & COFFEE

11 March 2014

09.00

VENUE & ACCOMMODATION

The Rembrandt Hotel, 11 Thurloe Place, London SW7 2RS

DIRECTIONS:

Opposite V&A Museum. Nearest underground station: South Kensington.

For more information visit http://www.researchandmarkets.com/research/wtkhb4/the_clinical

About Research and Markets

Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Research and Markets
Laura Wood, Senior Manager.
press@researchandmarkets.com
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Healthcare and Medical Devices, Pharmaceuticals

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