GOOD CLINICAL PRACTICE (GCP)

MONDAY 7 - WEDNESDAY 9 MARCH 2022

About

This virtual symposium is in partnership with the US Food and Drug Adminstration (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.   

 

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 1 - 7 March 2022 - 12:30-16:50 GMT

Day 1 Welcome

Opening remarks and keynote address

Session 1 - Building resilence into clinical trials

Session 2 - Risk based approach to sponsor oversight

Session 3 - Real world data/real world evidence

Break

Session 4 - Decentralised trials in the changing landscape

Panel discussion

Wrap up and closing remarks

GCP Day 2 - 8 March 2022 - 12:30-16:20 GMT

Day 2 Welcome

Opening remarks and keynote address

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

Break

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

Session 3 - Updates from each Agency

Panel discussion

Wrap up and closing remarks

GCP Day 3 - 9 March 2022 - 12:30-16:45 GMT

Day 3 Welcome

Opening remarks and keynote address

Session 1 - Issues and challenges identified within the clinic

Session 2 - Issues and challenges within the Bioanalytical Laboratory

Break

Session 3 - Regulatory updates

Panel discussion

Wrap-up and Closing Remarks

Register

Registration

GCP Commercial ticket

£ 450 +VAT

Registration

GCP Non-Commercial ticket

£ 350 +VAT

Registration

BE Commercial ticket

£ 250 +VAT

Registration

BE Non-Commercial ticket

£ 150 +VAT

Registration

GPS Week
7-11 March 2022

£ 695 +VAT