About
The Good Distribution Practice (GDP) event is suitable for all wholesalers, including those operating from registered pharmacies. The event would benefit the pharmaceutical wholesaling industry and associated companies in this field, including key staff members involved in procuring, supplying, exporting, and storing medicines as well as Responsible Persons and Quality personnel.
The Good Manufacturing Practice (GMP) event is ideal for pharmaceutical industry professionals in quality control, quality assurance, supply chain and production management, as well as regulatory and compliance specialists involved in the manufacturing of medicines. The GMP event is complemented by the Good Distribution Practice (GDP) event which covers distribution aspects.
These events will provide latest information and guidance on changing legislation and increasing complexity in the manufacturing and distribution chain. The symposium will offer a virtual or in-person learning experience addressing key topics and compliance trends observed by MHRA inspectors since the 2020 symposium, and also allowing for networking between delegates and submission of questions to the inspectors.
Participants of the GMDP Symposia will learn:
- Updates on the MHRA GMP and GDP inspection teams and risk-based Inspection programmes.
- MHRA Inspection positioning in our new regulatory world.
- Emerging trends in GDP including inspection compliance and in the areas of security, environmental changes and Responsible Person (importation), and a retrospective on 10 years of the Good Distribution Practice Guidelines
- Emerging trends in GMP including inspection compliance and in the areas of innovation, effective decision making and quality system robustness
CPD Accreditation
GDP: 5.50 for full attendance - Individual participants can only record the number of hours they attend
GMP: 5.50 for full attendance - Individual participants can only record the number of hours they attend
Agenda
Please note agenda timings are subject to change.
GDP Agenda — full schedule
February 21st, 09:30 - 17:00
Welcome And Introduction
Chris Gray — Head of Compliance Team 2, MHRA
GDP Inspectorate Updates
Tanya Giles — Head of GDP Team 1 and GDP Inspector, MHRA
An update on the MHRA GDP team and the new RBI Programme
Regulatory positioning
Peter Brown — Lead Senior GDP Inspector, MHRA
Cheryl Blake — Lead Senior GDP Inspector, MHRA
An update on the position in our new regulatory world, supply chains and current routes for NI supply, OS sites post EU exit, FMD and Compliance monitors.
Refreshments / Networking Break
Inspectors Surgery (In-person audience only)
Tanya Giles — Head of GDP Team 1 and GDP Inspector, MHRA
Cheryl Blake — Lead Senior GDP Inspector, MHRA
MHRA Enforcement Update
Andy Morling — Deputy Director Enforcement, MHRA
Security, new emerging trends
Peter Brown — Lead Senior GDP Inspector, MHRA
Terry Madigan — Senior GDP Inspector, MHRA
Lunch
Enforcement Q&A (In-person audience only)
Andy Morling — Deputy Director Enforcement, MHRA
Lunch
Inspectorate Surgery (In-person audience only)
Peter Brown — Lead Senior GDP Inspector, MHRA
Terry Madigan — Senior GDP Inspector, MHRA
GDP Compliance Data
Cheryl Blake — Lead Senior GDP Inspector, MHRA
Top 5 trends, IAG and CMT trends, case study
Environmental Changes and Impacts on GDP
Chris Watson — GDP Inspector, MHRA
Storing of medicines in extreme temperatures, interactive session
Refreshments / Networking Break
Inspectors Surgery (In-person audience only)
Cheryl Blake — Lead Senior GDP Inspector, MHRA
Chris Watson — GDP Inspector, MHRA
RPI Update
John McNulty — Head of GDP Team 2 and GDP Inspector, MHRA
Eligibility and suitability, what does good look like?
10 Years of the Good Distribution Practice Guidelines
Emanuela Krasteva — Senior GDP Inspector, MHRA
Review and forward look at changes and expectations
The Symposium Quiz
Claire Downes — GDP Inspector, MHRA
Lia Zelou — GDP Inspector, MHRA
Closing Remarks
Chris Gray — Head of Compliance Team 2, MHRA
After Hours Inspectors' Surgery (In-person audience only)
All MHRA GDP Inspectors
GMP Agenda — full schedule
February 22nd, 09:30 - 17:00
Welcome and Introduction
Chris Gray — Head of Compliance Team 2, MHRA
Keynote Address
James Pound — Deputy Director, MHRA
GMP Inspectorate Updates
Graham Carroll — Head of GMP Team 3 and Senior GMDP Inspector, MHRA
Regulatory Positioning
Ian Jackson — Expert GMP Inspector, MHRA
Refreshments / Networking Break
Inspectorate Surgery (In-person audience only)
Enabling Innovation
Ian Rees — Assessor, Innovation Accelerator, MHRA
Martine Powell — Lead Senior GMDP Inspector, MHRA
Discussion on the Inspection Action Group (IAG) and Compliance Monitoring (CM) processes
Jo Parkin — GMDP Inspector, MHRA
Chris Jones — Head of Regulatory Governance, MHRA
Ewan Norton — Lead Senior GMDP Inspector, MHRA
Lunch and video pop-ups
Inspectorate Surgery (In-person audience only)
HBB and BE: Callum McLoughlin – GMDP Inspector, MHRA
Annex 1: Alan Moon, Lead Senior GMDP Inspector, MHRA
PLPI: Fiona Murray and Ghazal Rehman – GMDP Inspectors, MHRA
DMRC Update: Himal Makwana, Head of Defective Medicines Reporting, MHRA
CBPMs: Ewan Norton, Lead Senior GMDP Inspector, MHRA
BP: Peter Crowley – BP Specialist, MHRA
Root cause analysis – Bias and effective decision making
Chris Gray — Head of Compliance Team 2, MHRA
Jo Parkin — GMDP Inspector, MHRA
Panel Q&A
Refreshments / Networking Break
Inspectorate Surgery (In-person audience only)
Quality system robustness
Shirley Stagg — Head of GMP Team 2, MHRA
Julio Benitez — GMDP Inspector, MHRA
Panel Q&A
Closing Remarks
Graham Carroll — Head of GMP Team 3 and Senior GMDP Inspector, MHRA
Chris Gray — Head of Compliance Team 2, MHRA
After Hours Inspectors' Surgery (In-person audience only)
All MHRA GMP Inspectors
Speakers
Venue
Accommodation
One Shortlands, Hammersmith, London, W6 8DR
Tel: 020 8741 1555
Register
Please check back for registration information.
Photo by Allie on Unsplash