Workshop on the new FDA draft guidance

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SMi Group are delighted to have industry expert Tom Parke to lead the post-conference workshop during Adaptive Designs in Clinical Trials 2019.

The 11th Annual Adaptive Designs in Clinical Trials conference, taking place in London on the 1st – 2nd April 2019, is a significant change from the 2010 version of the draft guidance. This workshop will look at the changes and what it means for submitting proposals for adaptive trials to the FDA.

It is highly beneficial for interested parties of this year’s event to attend the half day post-conference workshop on the 3rd April. SMi is delighted to host this workshop led by Tom Parke, Director of Software Solutions, Berry Consulting.

The workshop will cover key topics:

How to submit adaptive designs to regulators, what the contents of the documents should be, what simulation details need to be submitted, what problems to expect and how to submit simulation results and software.

More information on this workshop can be found on the event brochure and website on the associated events section, please go to http://www.adaptivedesigns.co.uk/pharmapr3

The workshop will provide the opportunity to learn and discuss the topic in a more intimate environment. Attend this workshop if you would like to understand how the new guidance reflects changes at the FDA, how to justify the use of an adaptive design to the FDA, how to document an adaptive design, how to organise, perform, and report the clinical trial simulations necessary to support an adaptive design and how to report the results of an adaptive design.

There is another option to attend a post-conference workshop taking place on the 3rd April about ‘Design and analysis of clinical trials evaluating novel digital technologiesled by Alex Sverdlov, Director of Biostatistics, Novartis and Yevgen Ryeznik, PhD, Uppsala University.

Register today to guarantee your place. Please go to http://www.adaptivedesigns.co.uk/pharmapr3

Adaptive Designs in Clinical Trials Conference 2019

Date: 1st – 2nd April 2019

Workshops: 3rd February 2019

Location: Holiday Inn, Kensington Forum

97 Cromwell Rd, Kensington, London SW7 4DN

For all media inquiries contact Jinna Sidhu on Tel: +44 (0)20 7827 6088 / Email: hsidhu@smi-online.co.uk

—ENDS—

About SMi Group:

Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk