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£90 – £150

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Half Day Good Clinical Practice Update Webinar

About this Event

This half-day GCP update webinar is being jointly provided by Shirley Hallam of Hallam Pharma Consulting Ltd and Trish Parry of Otus Clinical Services Ltd. Clinical Research has changed dramatically over the last few years with the changing landscape of the UK, Europe and Clincal Research globally. In this webinar, we will guidelines provided by EMA, FDA and HRA, how Brexit has changed the regulatory framework in the UK and EU over the last year, status of the EU Clinical Trials Regulation and ICH GCP Renovation updates (E6(R3) and E8(R1)). There will also be interactive workshops on monitoring and protocol deviations. An optional networking lunch is available. See agenda for the full schedule.

AGENDA:

10.00 Welcome and Introductions

10:15 Regulatory Updates including:

  • Post Brexit Updates
  • EU Clinical Trials Regulation 536/2014
  • ICH GCP Renovation (ICH E6(R3) and ICH E8(R1))

11.15 Quality Updates including:

  • Regulatory agency metrics reports
  • Inspection and audit findings

12.00 Optional Networking Lunch

13:00 Monitoring Interactive Workshop

14.00 Protocol Deviations Interactive Workshop

15.00 Finish time


		GCP Update Webinar image

Trish Parry is a training and clinical research consultant who has more than 30 years’ experience in clinical research. Trish has extensive experience in global monitoring, International clinical project management and as Director of Clinical Operations as a result of working in multi-national pharmaceutical companies and clinical research organisations. She has set up and maintained the European Clinical Quality and Training Department in a large US company and has 20-years’ experience as a trainer in clinical research and GCP.

Trish is author of Statistics in Clinical Research (The Institute of Clinical Research, 2004) and was on the Editorial Board of the Institute of Clinical Research’s Journal, CRFocus from 2005-2014. Trish is one of the founders of the Institute of Clinical Research Trainers Forum. She is a Chartered Scientist and member of Research Quality Association (RQA).


		GCP Update Webinar image

Shirley Hallam is a GCP auditor and clinical research consultant who has worked in the industry for over 20 years. She has conducted GCP audits of phase I-IV clinical trials in most European countries and the USA. She has completed BSI training as a lead auditor for ISO 9001:2015, holds the Institute of Clinical Research post-graduate diploma in Clinical Research, and the Research Quality Association (RQA) Certificate of Quality Management.

She currently divides her time between managing a Quality System for an emerging biotech company, conducting audits and delivering training. She is a course tutor on the RQA Advance Auditing Skills courses and regularly provides GCP training to Cambridge University NHS Trust. She is also a member of the RQA Global Engagement Team, involved in outreach to Trust-based and academic researchers.

For further information see website: www.gcp-quality.com.

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