The role of the pharmacy - Universitair Ziekenhuis Gent zorgaanbod... · 2016-09-23 ·...

© 2016 Universitair Ziekenhuis Gent

Clinical trials The role of the pharmacy

Els Kestens Responsible Pharmacist Clinical Trials 16 Sept 2016

2 © 2016 Universitair Ziekenhuis Gent

Organization

Activities

GMP-Licence

Quality system

Facility


Organization Chart Pharmacy

IMPLANTATEN MEDISCH

MATERIAAL

CSA

MEDICATIE

BELEID

TRANSMURALE

ZORG

KLINISCHE

FARMACIE

(BACK OFFICE)

CENTRAAL

DECENTRAAL

AUTOMATISATIE

MAGISTRAAL STERIEL

COMPOUN-

DING UNIT

ADMINI-

STRATIE DISTRIBUTIE

PRODUCTIE VALIDATIE

& VRIJGAVE

FARMACEUTISCHE ZORG

MEDISCH MATERIAAL

ASSISTENTEN

ASSISTENTEN

SECRETARIAAT

CEL

FINANCIEEL &

ADMINISTRATIEF BEHEER

CEL

KWALITEIT

FARMACEUTISCHE LOGISTIEK

ASSISTENTEN

PRODUCTIE

ASSISTENTEN

KLINISCHE STUDIES

ASSISTENTEN

DEPARTEMENTSHOOFD

APOTHEEK

O

_

O

_

O

O

_

O

_

O

O

_

O

_

O

O

_

O

_

O

O

_

O

_

O

ATMP

KLINISCHE

FARMACIE

(FRONT OFFICE)


Clinical trials department Responsible Pharmacist Teamleader

Els Kestens

Pharmacists

Evelien Haegeman

Charline Paepens

Pieter Ramaut

Pharmacy Assistants

Jasmin Bultinck

Sophie Caestecker

Ilse D’Haeyere

Brenda Grootaert

Charlotte Van Zaelen

Management Assistant

Karla Colaes


• Better span of control • Transparent separation of responsibilities • Deal with increasingly stringent requirements of

sponsors and agency • Enhanced training and continuous communication • Pharmacy activities with IMP only by qualified staff • Increased flexibility

Dedicated team


SCOPE

Phase 1 to Phase 4 trials with IMP

IMP-management confer GCP

GMP-activities

Sponsored and academic clinical research

Internal and external partners


Activities – IMP Management

Reception Storage

Distribution • Individual

delivery without preparation

• Individual delivery with preparation

•Reconstitution of cytotoxics,MABS, immunotherapies, vaccins, GMO’s,… and sterile

•Repackaging, randomisation, relabeling

•Single- en multiple dispensings

• GMP – activities •Relabeling, randomisation, production

Return/ destruction

Archiving

DRUG ACCOUNTABILITY RECORDING

0

50

100

150

200

250

300

350

400

450

500

20122013

20142015

24 24

29 54

456 458

432 465

Gesponsord

Academisch


0

5

10

15

20

25

30

35

40

45

20122013

20142015

%

Gesponsorde studies

Transit

Individuele aflevering

Reconstitutiesteriel/cyto

GMP activiteiten

Drug dispensings


0

5

10

15

20

25

30

35

40

45

20122013

20142015

%

Academische studies

Transit

Individuele aflevering

Reconstitutiesteriel/cyto

Labeling

GMP activiteit


Circular letter 596 25/02/2013 : IMP Production and distribution activities

Federal Agency Legislation

Storage Reconstitution and dispensing

Repackaging Other production activities

Phase 1 Units GDP - licence - GMP-licence GMP-licence

Hospital Pharmacies

- *

-*

-*

GMP-licence

Other GDP - licence

NA GMP-licence

GMP-licence

*Condition : operations in pharmacy – patients of the hospital


GMP-Licence 1763 IMP

• Non-sterile Products • Hard Capsules • Liquids for internal use • Liquids for external use • Batch certification

• Sterile Products • Batch certification

Production

• Batch certification for sterile en non-sterile products

Import


Cell therapie • Aseptic production of ATMP for clinical trials

• Since july 2016

UZ Gent : reference centre for GMP-

activities in the hospital setting

Organization Chart GMP-UNIT


Strenghts of GMP in the UZ Gent Pharmacy

Expertise

Small batches

Location

Flexibility

QP’s on site for release


GMP: a challenge in the hospital setting

Discrepancy between GMP-requirements and hospital Legislation for IMP

Stringent Quality system

Documentation of every deviation, change, event

Validation of process, infrastructure , equipments, personnel

Site Master File

Infrastructure

Release by QP

Extra costs


Supporting academic research

• Draw up IMPD • Drafting of preparation protocol • Randomisation, blinding and labeling

• Consultfunction • Perform specific training in reconstitution

• Auditfunction • Management of IMP at investigators site

• Storage, drug accountability, temperature monitoring

Supporting investigators

• Bimetra Clinics, DRUG, Cell Therapy, Phase-1 oncology steering group, EC, investigators site,…

Internal multidisciplinary collaborations


Quality system

Procedures

Studyspecific protocols • Chemopro • Validated protocols

New software package

GCP-qualification

Continuous training

Monitoring

Audits and inspections


Quality system

• Reporting and handling of complaints and deviations • Change control management • Recall procedures • Training of staff • Attending of audits • Managing of temperature monitoring • Maintenance, calibration and validation of infrastructure/

equipment • Managing of maintenance contracts

Cooperation with QUALITY CELL


Facility

• Dedicated rooms for storage and activities with IMPS • Closed unit • Temperature monitoring system

Legal Framework (GCP-GMP)

Centralisation towards more efficient operation

Optimalisation of good and activity flows

St

Entrance

Office

St

Entrance

Storage Room

Cytotoxic IMP reconstitution Room

Biosafety reconstitution room

IMP GMP Room


Contact Details

General [email protected] [email protected] 09/332.29.73 QP [email protected] [email protected] 09/332.44.56

mailto:[email protected]












The role of the pharmacy - Universitair Ziekenhuis Gent zorgaanbod... · 2016-09-23 ·...

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