Good Manufacturing and Distribution Practice Symposia 2023

21 February - 22 February 2023

Novotel London West / Virtual

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

Novotel London West

Event Venue

International Centre, 1 Shortlands, London, W6 8DR

Tel: (+44) 20 8741 1555

Website

Accommodation

Register

Please check back for registration information.


Photo by Allie on Unsplash

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