13 - 14 February 2020, Novotel London West

Good Clinical Practice Symposium (Commercial) 2020

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About

This Symposium is in partnership with the US Food and Drug Administration (FDA).

Regulatory agencies conduct Good Clinical Practice (GCP) inspections to assure the integrity of data generated in clinical trials and to confirm the protection of human research subjects, in addition to ensuring that clinical trials are conducted according to the applicable regulations.  With the globalisation of clinical trials, regulators have increased collaboration amongst themselves to evaluate the adequacy of clinical trial conduct to optimise regulatory resources and oversight.

This event continues the discussion from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration’s (FDA), Center for Drug Evaluation and Research (CDER) October 2018 GCP Symposium: Data Integrity in Global Clinical Trials - Are We There Yet? This event will provide regulatory perspectives on the importance of sponsor oversight of clinical sites and laboratories, eSource including electronic health records, protocol deviations including the impact on clinical trials, and the challenges in ensuring data quality in novel clinical trial designs. On day two workshop participants will have opportunities to work on relevant case studies on these topics.

At this symposium, participants will learn:

  • Key aspects regarding sponsor oversight of clinical investigator sites and laboratories
  • Impact of eSource on clinical data
  • Investigator control of their data
  • Impact of data quality on decision making
  • How handling of protocol deviations impact data reliability and subject safety
  • The challenges faced in ensuring data quality in novel clinical trial design

 

New for 2020, this year's symposium will reach a global audience with the introduction of livestreaming. This new interactive element will provide those unable to attend in person a unique opportunity to gain access to key presentations from the MHRA and FDA.

Please note livestreaming is only available on day one (Thursday 13 February 2020).


MHRA Good Practice Symposia Week

The joint MHRA and FDA GCP Symposium is part of a week-long series of events led by the MHRA Inspectorate. Interested in attending more than one symposium? Details of discounted combined tickets are listed in the registration section via the Register link above.

 

Good Pharmacovigilance Practice (GPvP)

The 2020 GPvP Symposium will provide an insight into the key topics and compliance trends in pharmacovigilance observed by the MHRA GPvP inspectors since the 2018 Symposium. The event is relevant to anyone working in pharmacovigilance, medical information and regulatory affairs, including EU QPPVs and service providers.

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MHRA Laboratories Symposium (Labs)

The 2020 MHRA Laboratories Symposium will highlight the importance of 'fit for intended use' in the context of regulated work across GLP, GCP and GMPQC Laboratories. The content of the event is intended to illustrate that this topic is not just limited to facilities and equipment but can be applied across an organisation, from people and training to quality management systems and report production.

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GCP Symposium

Agenda

Please note programme and timings are subject to change.

GCP Symposium

Day 1 — full schedule

13 February 2020, 08:30 - 17:30

Registration and refreshments

Welcome and Introduction

Paula Walker — Unit Manager Inspectorate Operations, MHRA

Keynote Address

Sam Atkinson — Director Inspections, Enforcement & Standards, MHRA

Update on International Collaboration

Gail Francis — Expert Inspector, GCP, MHRA

Dr Ni Khin — Division Director, FDA

  • FDA/MHRA GCP/BE Activities
  • Welcoming Health Canada

Sponsor Oversight: International Perspective

Moderator: Sean Kassim, FDA

  • Learning from Bioequivalence (BE) inspections
  • Key aspects regarding oversight of clinical investigator sites and laboratories

Key Considerations for Sponsorship of the Clinic and Laboratory
  • Stephen Vinter — Operations Manager Laboratories Group, MHRA
FDA Perspective on International Clinical Trials
  • Kassa Ayalew — Branch Chief, FDA

Refreshments, networking and Inspector Surgeries

E-Source including Electronic Health Records

Moderator: Sean Kassim, FDA

  • Investigator control of their data
  • Source data capture methodologies
  • Maintaining the full patient journey

Current Challenges with eSource (based on the EU experience)
  • Andy Fisher — Lead Senior GCP Inspector, MHRA
eSource: Practical Examples
  • Dr Phillip Kronstein — Lead Medical Officer, FDA

Panel Discussion

Lunch, networking and Inspector Surgeries

Protocol Deviations: Identification, Impact, and Reporting

Moderator: Gail Francis

  • Understand how protocol deviations impact data reliability and subject safety when not properly identified, tracked, analysed and reported
  • Discuss challenges and opportunities in protocol deviation management
  • Examine how current practices may impact data quality and ultimately the acceptability of study results for regulatory review

Violations and Deviations: Is Anyone Really Happy with Current Handling?
  • Dr Jean Mulinde — Senior Advisor, FDA
Management of Protocol Deviations: Identification, Classification, Use in Analysis
  • Jennifer Martin — Lead Senior GCP Inspector and Operations Manager, MHRA
Impact of Protocol Deviations on Bioequivalence Evaluations
  • Dr Julia Cho — Division Director, FDA

Refreshments, networking and Inspector Surgeries

Challenges in Ensuring Data Quality in Novel Clinical Trial Design

Moderator: Kassa Ayalew

  • Trial Management of dose escalation
  • Importance of analytical data quality in decision making
  • Decentralized trials

Considerations for the Design and Conduct of Decentralised Trials: Regulatory Perspectives
  • Dr Cheryl Grandinetti — Pharmacologist, FDA
Adaptive trials and dose escalation
  • Mandy Budwal-Jagait — Senior GCP Inspector, MHRA
  • Michael McGuinness — GLP & GCP Inspector, MHRA

Panel Discussion

Debbi Fox — Compliance Specialist, Health Canada

Mandy Budwal-Jagait — Senior GCP Inspector, MHRA

Wrap-Up & Overview of Day 2 Case Studies

Paula Walker — Unit Manager Inspectorate Operations, MHRA

Closing Address

Dr Laurie Muldowney — MD, Deputy Director, FDA

Day 2 — full schedule

14 February 2020, 08:00 - 14:00

Registration and refreshments

Welcome and Introduction

Jennifer Martin — Lead Senior GCP Inspector and Operations Manager, MHRA

Case Study Session 1

Moderator: Jennifer Martin

Please note, these sessions are run in parallel. At the time of booking you will be asked to select one workshop from session 1 and one workshop from session 2. 

* GCP ePRO source data is now fully booked.

Bioanalytical approaches to mitigate issues identified during BE clinical site inspection
  • Arindam Dasgupta — FDA
  • Emma Whale — Senior GCP and GLP Inspector, MHRA
  • Jason Wakelin-Smith — Lead Senior GCP and GLP Inspector, MHRA
  • Andrace De Yampert — Bioresearch Monitoring Specialist, FDA
GCP ePRO source data
  • Gail Francis — Expert Inspector, GCP, MHRA
  • Paula Walker — Unit Manager Inspectorate Operations, MHRA
  • Dr Phillip Kronstein — Lead Medical Officer, FDA
  • Rachel Skeete — Lead Medical Officer, FDA
  • Andy Fisher — Lead Senior GCP Inspector, MHRA

Refreshments and networking

Case Study Session 2

Moderator: Jean Mulinde

Please note, these workshops are run in parallel. At the time of booking you will be asked to select one workshop from session 1 and one workshop from session 2. 

* Handling protocol deviations is now fully booked

Laboratory audit trails
  • Arindam Dasgupta — FDA
  • Emma Whale — Senior GCP and GLP Inspector, MHRA
  • Jason Wakelin-Smith — Lead Senior GCP and GLP Inspector, MHRA
  • Dr Julia Cho — Division Director, FDA
  • Michael McGuinness — GLP & GCP Inspector, MHRA
Handling protocol deviations
  • Bei Yu — FDA
  • Barbara Wright — Supervisory Investigator, FDA
  • Dr Ni Khin — Division Director, FDA
  • Hayley Dixey — GCP Inspector, MHRA
  • Debbi Fox — Compliance Specialist, Health Canada
  • Mandy Budwal-Jagait — Senior GCP Inspector, MHRA

Wrap-up and Q&A

Paula Walker — Unit Manager Inspectorate Operations, MHRA

Closing Address

Dr Andrew J Gray — Head of Inspectorate and Deputy Director IE&S, MHRA

Lunch and networking

Register

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GCP 1.5 day ticket

£ 875 +VAT

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GCP 1 day livestreaming

£ 150 +VAT

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GCP Non-Commercial 1 Day Livestreaming

£ 100 +VAT

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GCP Non-Commercial 1.5 Day Ticket

£ 590 +VAT

Speakers

Venue

London

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