GCP Update Webinar Recording - 20th January 2025

Agenda:

09.30 - Welcome and Introductions

09:45 - Regulatory Updates:

• UK updates including:

1. MHRA updates
2. Lord O’Shaughnessy Report
3. NCVR

• EU Clinical Trial Regulation 536/2014

1. CTIS updates – publishing trials and transitioning, FAQs

• Declaration of Helsinki 2024
• WHO Guidance for best practices for clinical trials 2024

11.00 - Break

11.15 - ICH E6 (R3) Updates:

• Data Governance

• Essentiality of documents

• Regulatory expectations
• Sponsor and investigator oversight

12.30 - Optional Networking Lunch

13:15:

• Sponsor Oversight workshop

1. Inspector expectations
2. Electronic systems

14.15 - Break

14.30:

• Decentralised Trials
• Real World Evidence / Real World Data

15.30 - Finish

This Good Clinical Practice Update webinar brings your attention to important GCP and Regulatory Updates in the last 6 months-1 year. We will focus on MHRA, EU and FDA updates, the update to the Declaration of Helsinki and progress of the ICH GCP Renovation (ICH E6 and E8 revisions). This will be followed by an optional virtual networking lunch. The afternoon sessions will be interactive workshops focusing on the themes of Sponsor Oversight and Decentralised Trials.

Trish Parry is founder and CEO of INDICRO Ltd., a digital hub connecting Life Science R&D Experts, Outsourcers and Service Providers since May 2023.. Her background is a training and clinical research consultant with more than 30 years’ global experience. Her clinical research expertise includes development of clients Clinical Quality Management Systems, clinical trial design and planning, clinical trial set up and oversight, clinical project management for all stages of clinical trials, Research Ethics Committee an regulatory submissions, vendor management and oversight, medical writing, monitoring and co-monitoring. She has experience of all phases of clinical trials and in international roles ranging from CRA to Director of Clinical Operations. Trish was a Clinical Subject Matter Expert in the Vaccines Taskforce (now the COVID Vaccines Unit) in UKHSA during the COVID pandemic.

Trish has developed and delivered many Transcelerate accredited courses and workshops on Good Clinical Practice to sponsors, investigators and universities. Trish also develops bespoke workshops and mentoring programmes in monitoring, advanced monitoring, clinical project management, vendor management, trial master file management and inspection readiness for clients. Many of the courses have been delivered internationally, in Europe, Turkey, Singapore and Dubai.

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, is Co-Chair of the Institute of Clinical Research Ethics and GCP Forum and a Sub-Leader for the UK Clinical Trials Talent Taskforce (CTTT). She is a Chartered Scientist and a member of Research Quality Assurance (RQA), Bioindustry Association (BIA), Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI) and the UK based Independent Clinical Research Freelance Network (ICRFN). Trish is the Managing Director for Otus Clinical Services Limited since 2004, where she provides consulting services to the clinical research community.

For more information, please visit: www.indicro.com

Shirley Hallam is a GCP auditor and clinical quality assurance consultant who has worked within in the pharmaceutical industry for over 30 years, for pharmaceutical companies, Contract Research Organisations and non-commercial sponsors. She has conducted around 300 GCP audits of phase I-IV clinical trials in most European countries and the USA, with experience of investigational site, trial master file, database and clinical study report audits. She has assisted with preparing organisations for successful inspection with the MHRA, EMA and FDA.

Shirley advises on clinical quality management systems, including writing Standard Operating Procedures, and developing CAPA reports and vendor oversight processes. She is an experienced trainer, delivering Transcelerate Biopharma registered GCP training courses to NHS Trusts and industry bodies, and was formerly the course principal for the RQA Advanced Audit Skills courses. In 2016 she completed training with the British Standards Institute 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.

Shirley is founder and Managing Director of Hallam Pharma Consulting Ltd. For further information see website: www.gcp-quality.com.