Monitoring Safety in Clinical Trials and Drug Development2018-11-20T11:12:34+00:00

Project Description

Monitoring Safety in Clinical Trials and Drug Development

Course overview

Venue:  Novotel London West Hotel, Hammersmith, London

Date: 30 Jan – 31 Jan 2019*

The implementation of the Clinical Trials Directive was a critical event for clinical research and pharmacovigilance, which impacted on all those working in this area. Its standards have influenced regulatory expectations, together with new ICH standards such as the Development Safety Update Report and pharmacovigilance planning, bringing new challenges to safety personnel. The Directive is being further enhanced and evaluated, challenging the traditions of approaches to clinical trials with respect to safety data management and protocol designs. In addition, post authorisation GVP provides specific guidance on the management of Post Authorisation Safety Studies. Our Monitoring Safety in Clinical Trials and Drug Development course is aimed at providing delegates with an overview of some of the challenges companies faced in implementation of safety standards and best practice in managing their implementation in order to comply with applicable legislation and guidance both pre- and post-authorisation

*Please note that the course dates and programme may be subject to change.

 Our courses are recognised by PharmaTrain.

Who should attend?

This course is aimed at:

  •  Pharmaceutical industry personnel from areas including pharmacovigilance, clinical research, medical affairs, medical writing, regulatory affairs and medical information
  • Staff from regulatory authorities

Aims of course

  • To provide delegates with a theoretical and practical understanding of the issues involved in pharmacovigilance planning and monitoring throughout drug development programmes
  • To analyse the principles of risk management and illustrate their application to pharmacovigilance, including the role and application of Data Safety Monitoring Boards
  • To review critically pharmacovigilance regulatory requirements plus corresponding roles and responsibilities of the pharmaceutical industry in safety data management for optimal protection of patients in clinical trials

Learning Outcomes

On successful completion of this course delegates should be able to:

  • Demonstrate an informed critical awareness of regulatory safety requirements as they pertain to clinical studies
  • Understand the role and situations where a study may deploy the use of Data Safety Monitoring Boards
  • Identify and locate the key sources of information and documentation relevant to developmental risk management activities
  • Critically explain the strengths and weaknesses of pharmacovigilance planning systems

Key Topics

Programmed features:

  • Pharmacovigilance planning and monitoring in drug development, including communication to trial subjects
  • Development of labelling – the developmental safety information through the core data sheet and SPC
  • Risk management in drug development – planning and risk minimisation
  • Monitoring safety in clinical trials
  • Data Safety Monitoring Boards
  • Clinical Trials Directive – current requirements, challenges and future changes
  • Planning for the Developmental Safety Update Report
  • Reporting to Eudravigilance Clinical Trial Module – practicalities and challenges
  • Future drug safety regulatory challenges on the horizon for the clinical trials and drug development

Fees

Cost Per Delegate:

£775 + VAT Academic

(Academic Units, Public Sector Organisations, Registered Charities)

Or

£1190 + VAT Standard

(Standard Registration)

Download Course Programme

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Booking options

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TESTIMONIALS

“Very good course. Lots of new information and a brilliant overview of Clinical Trials.

Monitoring Safety Delegate 2018

“Speakers very knowledgeable and willing to share experiences.

Monitoring Safety Delegate 2018

“Important and relevant topics covered by very experienced speakers.”

Monitoring Safety Delegate 2018

“The interactive sessions were really beneficial. All presenters were really knowledgeable and imparted great experience and wisdom.”

Monitoring Safety Delegate 2017

Great meeting, I learnt loads and found it all very beneficial. Would strongly recommend to others.”

Monitoring Safety Delegate 2017

“Excellent standard of presentations and very well run!”

Monitoring Safety Delegate 2016

Course Leader

Jo Webbe – Director, Drug Safety & Public Health

Jo is currently a Director within the Standards & Collaborations team of the Drug Safety & Public Health department at Gilead Sciences International Ltd.  Jo has a BSc (Hons) in Biology (Physiology with Molecular Biology).  Jo joined Gilead in January 2006 as Manager of Clinical Trials in the Adverse Event Management team before transferring to primarily focus on Safety Data Exchange Agreements and Affiliate support in June 2007.  Jo has worked for nine years in Pharmacovigilance within the Pharmaceutical Industry.

Contact Info

Drug Safety Research Unit Bursledon Hall, Blundell Lane, Southampton, SO31 1AA, U.K.

Phone: +44 (0)23 80 40 86 00

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