GOOD CLINICAL PRACTICE (GCP)

MONDAY 7 - WEDNESDAY 9 MARCH 2022

About

This virtual symposium is in partnership with the US Food and Drug Administration (FDA) and Health Canada (HC).

FDA and Health Canada

Regulatory agencies conduct Good Clinical Practice (GCP) inspections to confirm that participants are adequately protected, to ensure the reliability of the results generated, and to ensure that clinical trials are conducted according to the applicable regulations.  With the recent COVID-19 pandemic changing the landscape of clinical trials and decentralisation of clinical trials, regulators have optimised regulatory resources and oversight by increasing collaboration to evaluate the adequacy of clinical trial conduct. 

This virtual workshop follows previous joint events between the United Kingdom’s Medicines and Healthcare product Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA), including workshops in October 2018: Data Integrity in Global Clinical Trials- Are We There Yet? and February 2020: Data Integrity in Global Clinical Trials- Tackling Challenging Topics.  At this event, the MHRA and FDA welcome Health Canada (HC) to the collaboration.

The COVID-19 pandemic has necessitated flexibility in trial conduct and accelerated changes in the clinical trial landscape. Regulators have also provided new guidance on trial conduct, taking a pragmatic and proportionate approach for trials being conducted during the pandemic. Moving forward, it will be important to leverage the use of more innovative tools and approaches to trial design, conduct, and inspections, including remote approaches.

This event will provide regulatory perspectives on how maximising our understanding and use of risk-based approaches can build resilience into clinical trials, allowing flexibility in the protocol and clinical trial conduct while still ensuring participant safety and reliable results. We will discuss continuing developments in decentralised trials, use of real-world data and real-world evidence in regulatory decision making, and the importance of sponsor oversight.

The event will also include sessions dedicated to the conduct of bioequivalence (BE) trials. Regulators will provide their perspectives on common issues and challenges in the conduct of the clinical and bioanalytical components of BE trials and provide important updates on guidance and inspection activities.

At this event, participants will learn:

  • Key aspects of building resilience into clinical trials
  • Risk-based approach to sponsor oversight
  • Use of real-world data/real-world evidence
  • Updates regarding decentralised trials
  • Changes in clinical trial activities and inspections
  • Sponsor oversight of vendors
  • Potential uses of artificial intelligence and machine learning in clinical trials
  • Clinical and bioanalytical challenges in bioequivalence trials
  • Updates in guidance and inspection approaches


Due to the ongoing worldwide COVID-19 pandemic, the symposium will be delivered as a livestreamed, online-only event. Content will be made available to all registered delegates as recordings after the symposium, allowing access at the most convenient time for you. This may be of particular interest where time zones make it difficult to watch the event in real time.

Please note your GCP ticket provides access for the full 3 day programme (Monday 7 – Wednesday 9 March). If you only wish to attend day 3 (Wednesday 9 March) which will be focusing on Bioequivalence you can purchase a single day ticket either commercial/non-commercial depending on your organisation type.   


CPD credits: 11.05 credits available for full attendance 7-9 March 2022, please note individuals should only record the number of hours they attend.

 

MHRA Good Practice Symposia week
The joint MHRA, FDA and Health Canada GCP Symposium is part of the MHRA Good Practice Symposia week which will provide you with insight into key topics, compliance trends and the opportunity to hear first-hand from MHRA Inspectors and speakers from FDA and Health Canada. Good Practice Symposia week will also include the Good Pharmacovigilance Symposium.

Good Pharmacovigilance Symposium
Thursday 10 – Friday 11 March 2022, 12:00-16:45

The 2022 Good Pharmacovigilance (GPvP) Symposium will deliver insightful discussions on  the key topics and compliance trends in pharmacovigilance, observed by MHRA GPvP inspectors since the 2020 Symposium.

This two-day event is relevant to anyone working in pharmacovigilance, medical information and regulatory affairs, including UK QPPVs and service providers.

Click through for further information on this year’s event including ticket options


Questions For The Panel

Once you have registered, you will have the opportunity to submit pre-event questions to our panel of speakers via the Delegate Area. You will be issued with login details on your registration confirmation email. The team will endeavour to answer as many of these questions as they can at the event.

To submit your questions, please log into the Delegate Area and go to Panel Questions in the menu.

Twitter - #MHRAGCP22

Agenda

Please note programme and timings are subject to change.

GCP Day 3 - 9 March 2022 - 12:30-17:00 GMT

Day 3 Welcome

Stephen Vinter — Head of GLP/ Laboratories, MHRA

Opening remarks and keynote address

Dr. Carole Légaré — Director, Office of Clinical Trials, Therapeutic Products Directorate (TPD), Health Products and Food Branch, Health Canada

Session 1 - Issues and challenges identified within the clinic

(Moderators – Scott Appleton, Ph.D. & Leslie Vrooman, MSc., DBE/TPD/HC)

 

Emma Whale — Senior GCP/GLP Inspector, MHRA

Session 2 - Issues and challenges within the Bioanalytical Laboratory

(Moderator – Stephen Vinter, MHRA)

  • Data Integrity Violations in BA/BE Studies - Case studies presenting key data integrity issues from data submitted to the FDA
  • Effective use of guidance - A presentation discussing common inspection findings where laboratories have failed to follow recognised bioanalytical guidance.
  • Internal Standard response monitoring - Case Studies from data submitted to Health Canada highlighting the importance of monitoring performance and evaluating trends.

 

Arindam Dasgupta, Ph.D., — Deputy Division Director, OSIS/FDA

Michael McGuinness — Senior GLP & GCP Inspector, MHRA

Susan Stojdl, MSc., — Senior Clinical Assessment Officer, DBE/TPD/HC

Break

Session 3 - Regulatory updates

(Moderator – Julia Cho, Ph.D., FDA)

  • An overview of and update on the draft ICH M10 Bioanalytical Method Validation Guideline
  • An update on FDA’s inspections and use of remote activities for bioavailability and bioequivalence studies submitted in U.S. drug and therapeutic biologic applications
  • An update on the current and future inspection approaches for studies submitted to the MHRA

 

Dr. Anna Edmison, Ph.D. — Senior Clinical Assessment Officer, DBE/TPD/HC

Stephen Vinter — Head of GLP/ Laboratories, MHRA

Sean Kassim, Ph.D., — Office Director, OSIS/FDA

Panel discussion

(Moderator- Lina Alshobly, MSc, CTCP/HC)

 

Wrap-up and Closing Remarks

Laurie Muldowney, M.D., — Deputy Director, OSI/FDA

GCP Day 2 - 8 March 2022 - 12:30-16:30 GMT

Day 2 Welcome

Paula Walker — Head of Compliance (1), GCP, GPvP & GLP, MHRA

Opening Remarks and Keynote Address

Dr Laura Squire OBE, Ph.D., — Chief Officer, Healthcare Quality & Access, MHRA

Session 1 - Have regulatory expectations changed as a result of the pandemic

(Moderator – Asma Syed, MSc., Health Canada)

  • The challenges and changes experienced for GCP inspections during the pandemic
  • Expectations of the three regulatory agencies regarding research conducted during the pandemic
  • Changes to research and regulatory oversight moving forward

 

Rachel Mead, B.Sc., — GCP Inspector, MHRA

Barbara Wright — Supervisory Investigator, Foreign Inspection Cadre, FDA

Shila Rastegar, MSc., — Compliance Specialist, ROEB/HC

Break

Session 2 - Potential uses of Artificial Intelligence and machine learning in clinical trials

(Moderator – Dr. Rachelle M. Swann, FDA)

  • Brief overview of AI and ML
  • Potential uses and challenges of applying artificial intelligence and machine learning in clinical trials
  • Considerations for ensuring GCP compliance

 

Mathew Thomas, M.D., — Senior Policy Advisor, OSI/ FDA

Session 3 - Updates from each Agency

(Moderator – Paula Walker, MHRA)

  • Updates regarding legislation, guidance and forward look from each of MHRA. FDA and Health Canada respectively.

 

Laurie Muldowney, M.D., — Deputy Director, OSI/FDA

Dr. Martin O'Kane — Head of Clinical Trials, MHRA

Alex Basiji — Director, Health Canada

Panel discussion

(Moderator- Miah Jung, PharmD, FDA)

 

Wrap up and closing remarks

Asma Syed, MSc., — A/National Manager, ROEB/HC

GCP Day 1 - 7 March 2022 - 12:30-17:00 GMT

Day 1 Welcome

Paula Walker — Head of Compliance (1), GCP, GPvP & GLP, MHRA

Opening remarks and keynote address

Donald Ashley, J.D., — Director, Office of Compliance, FDA

Session 1 - Building resilence into clinical trials

(Moderator- Paula Walker, MA, MHRA)

  • Novel & resilient approaches to clinical trials: COVID-19 and non-pandemic clinical trials; lessons learnt, including legislative changes in respective regions
  • Quality by Design: building resilience into trials in the changing landscape
  • Implications for the future across all clinical trial types

 

Kirsty Wydenbach, MB BS., — Deputy Unit Manager / Expert Medical Assessor, MHRA

Jean Mulinde, M.D. — Senior Policy Advisor, OSI/ FDA

Asma Syed, MSc., — A/National Manager, ROEB/HC

Session 2 - Risk based approach to sponsor oversight

(Moderator- Debbi Fox, BSc., HC, Health Canada)

  • Quality by Design in Clinical Trials
  • Adaptive Approaches – Building flexibility into sponsor oversight
  • Current Considerations for Risk Based Monitoring

 

Hayley Dixey — Senior GCP Inspector, MHRA

Miah Jung, PharmD — Branch Chief, OSI/FDA

Adil Nashed, B.V.Sc, D.H.M.S., — Compliance Specialist, ROEB/HC

Session 3 - Real world data/real world evidence

(Moderator - Kassa Ayalew, M.D., FDA)

  • Real World Data/Real World Evidence: Setting the Stage and Introducing the MHRA guidance related to RWD
  • Inspectional Case Examples and Data Reliability Evaluations in Studies using RWD/RWE for Regulatory Decision-Making
  • Summary of Quality Expectations for Use of RWD/RWE for Regulatory Decision-Making

 

David Brown — Acting Manager Statistics and Pharmacokinetics Unit, MHRA

Cheryl Grandinetti, PharmD, — Clinical Pharmacologist, OSI/FDA

Jason Wakelin-Smith BSc., PTQA — Lead Senior GCP Inspector, MHRA

Break

Session 4 - Decentralised trials in the changing landscape

(Moderator – Andy Fisher, MSc, MHRA)

  • What is a DCT?
  • Examples of DCTs
  • Experiences of implementing DCTs during COVID 19 pandemic
  • Existing and New Features of DCTs
  • Challenges and opportunities of DCTs
  • Awareness of guidance available for DCTs

 

Phillip Kronstein, M.D., — Lead Medical Officer, OSI/FDA

Kirsty Wydenbach, MB BS., — Deputy Unit Manager / Expert Medical Assessor, MHRA

Khadija Rantell — Senior Statistical Assessor, MHRA

Alicja Kasina — Senior Regulatory Advisor, Health Canada

Panel discussion

(Moderator- Paula Walker, MA, MHRA)

 

Wrap up and closing remarks

Paula Walker — Head of Compliance (1), GCP, GPvP & GLP, MHRA

Speakers

Register

Registration

GCP Commercial ticket

£ 450 +VAT

Registration

GCP Non-Commercial ticket

£ 350 +VAT

Registration

Bioequivalence Commercial ticket

£ 250 +VAT

Registration

Bioequivalence
Non-Commercial ticket

£ 150 +VAT

Registration

GPS Week
7-11 March 2022

£ 695 +VAT