Victoria Pharmaceuticals Clinical Trial Manufacturing Service

Fiona Taylor Clinical Trials Production

Pharmacist

Victoria Pharmaceuticals Clinical Trial Manufacturing

Service

Victoria Pharmaceuticals At Victoria Pharmaceuticals we pride ourselves on our product quality and a high level of customer service.

Victoria Pharmaceuticals Victoria Pharmaceuticals is a ‘Specials’

manufacturing unit within Belfast Health and Social Care Trust. Based on the Royal Hospital site.

Manufacture a range of sterile and non sterile specials.

Manufacture Investigational Medicinal Products

We hold a specials licence and an IMP licence granted by the MHRA.

Our Facility Our production unit was commissioned for use In 2010

State of the art facility. Sterile and non-sterile capability.

The IMP Production Process

Proposal / Idea Feasibility Options & Quotations

Project Plan Prepare

Documentation for regulatory submission

Sourcing of Raw Materials

Plan Production of Batches

Manufacture IMP Distribution

Stage 1

Proposal – Information from Investigator

Feasibility – Capacity planning

Quotation – Options provided

Stage 2

Project Plan – Timelines – Plan manufacturing / assembly process – Train staff to carry out processes – Distribution logistics – Temperature monitoring – Problem solving

Stage 3

Preparation of Documentation for Regulatory Submission – Technical agreement – IMPD – Placebo Dossier – Product Specification File – SmPC – Summary of product characteristics – TSE information

Stage 4

Sourcing of raw materials – Licensed product – Placebo components

Plan production of batches – Projected recruitment – Expiry of IMP – Number of sites

Stage 5

Manufacture of IMP – Planning production – Training staff – Preparation of documentation

Distribution – Multi-centre / single centre study – Is temperature monitoring required? – Cold chain distribution?

Previous, Current and On-going Projects

Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction (HARP2)

A Randomised Controlled Trial of Calcium Channel Blockade with Amlodipine For the Treatment oF Subcortical IschaEmic VasCular DemenTia (AFFECT)

A Randomised Double Blind Placebo-Controlled Clinical Trial of a Single Oral Cholecalciferol Treatment Against Surrogate End Point Biomarkers (SEBs) in Colorectal Cancer (CRC) Patients

A randomised placebo-controlled pilot trial of omeprazole in idiopathic pulmonary fibrosis (IPF)

Effect of vitamin D3 supplementation on insulin resistance and cardiovascular risk factors in people at high risk of type 2 diabetes and cardiovascular disease.

Problem Solving Change in active capsule colour Change in size of active tablet Active product discontinued Change in active tablet appearance

What can we do for you? Innovative product design Cost advice and analysis Bespoke labelling Manufacturing of clinical trial medication Blinding QP release Preparation of documentation for regulatory

submission Distribution throughout UK and Ireland Advice and support

Questions