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We are pleased to confirm details of the first Seminar in our QRCC 2019 Seminar Series

Registration is now open !

 

Date:                     Thursday 21st March 2019

Time:                     9.00am to 1.00pm (seminar includes a light lunch)

Venue:                  QRCC, Silvaco Technology Centre, St Ives, PE27 5JL

Cost:                     ¬£180 plus VAT (cost includes refreshments)

 

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The seminar will cover aspects of the use of Reference Safety Information (RSI) for regulatory reporting in the clinical trial context.  We will consider the regulatory basis for the RSI and why this is important to the conduct of any clinical trial.  We will discuss how to write and how to maintain the RSI as part of the Investigator Brochure (IB) and we will look at examples of non-compliance and GCP inspection findings to highlight key points. Considerations for IBs, clinical protocols, safety management plans and SOPs will also be discussed.

 

Speakers :-

Sarah Nicholson, Director and Head of Regulatory, QRCC

Alex Gage, Head of Clinical Operations, QRCC

Sarah Fryer, Director and Head of Quality, QRCC

Jenny Velińá, Regulatory Consultant, QRCC

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Who should attend :-

Regulatory Affairs, Clinical Operations, Safety Reporting and GCP QA professionals responsible for the set-up, conduct and/or management of clinical trials.

 

A certificate of attendance will be provided for all delegates.

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Registration fee: £180 + VAT

 

BOOK YOUR PLACE NOW: e-mail: enquiries@qrcc.co.uk or phone: 01480 309349