GCP Update Webinar

Otus Clinical Services Ltd. and Hallam Pharma Consulting Ltd

<h3>AGENDA:	</h3>09.30 Welcome and Introductions 09:45 Regulatory Updates including:<ul><li>General trends</li></ul><ul><li>UK updates including </li></ul><ol><li>UK Legislation Consultation</li><li>Lord O&#x27;Shaughnessy Report</li><li>MHRA updates</li><li>NCVR</li></ol><ul><li>EU Clinical Trials Regulation 536/2014 including </li></ul><ol><li>EMA Computerised systems guidance</li></ol>11.00 BREAK11:15 Hot Topics<ul><li>ICH GCP (ICH E6) (R3) draft</li></ul><ol><li>Decentralised trials</li><li>Patient centric trials</li><li>Real World Evidence</li></ol><ul><li>CDISC TMF Iterchange</li></ul>12.30	 Optional Networking Lunch13:15	 Data Privacy and Data Integrity Interactive Workshop<ul><li>MHRA Data Integrity Guidelines</li><li>GDPR and ICO Registration</li><li>Writing a data privacy impact assessment</li></ul>14:15 BREAK14.30	 Inspection findings Interactive Workshop<ul><li>MHRA guidance on CAPAs</li><li>How to draft the perfect response</li><li>How to implement CAPAs</li></ul>15.30	 Finish time

This one-day GCP update webinar is being jointly provided by Shirley Hallam of Hallam Pharma Consulting Ltd and Trish Parry of Otus Clinical Services Ltd. We will be sharing the latest updates affecting clinical research in the UK, the EU Clinical Trials Regulation and ICH GCP Renovation updates (E6(R3) and E8(R1). There will be sessions on the latest hot topics including decentralised trials, Real World Data and patient involvement in clinical trials. There will also be interactive workshops on Data Privacy/Integrity and inspection findings. An optional networking lunch is available. See agenda for the full schedule.Three types of ticket re available:1. Attend the live webinar, with certificate issues on completion of quiz2. Purchase recording of webinar (not including the interactive sessions) with certificate issues on completion of quiz3. Purchase recording of webinar only (not including the interactive sessions)

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. 
More recently, Trish was a Clinical Subject Matter Expert in the Vaccines Taskforce, in UKHSATrish 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 and is a member of the Clinical Trial Regulation Trainers Forum. She is a Chartered Scientist and member of Research Quality Association (RQA).

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

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GCP Update Webinar

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GCP Update Webinar

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