Transcript D699BC00001

D699BC00001(FALCON)
Drug Supply
D699BC00001
Contents

Trial Design

Packaging

Labelling

Supply Strategy

Distribution

Temperature Excursions

Expiry Management

Returns & Destruction

Contacts
D699BC00001
Trial Design
Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study.
Drug Supply will be managed using IVRS/IWRS
Each patient will be randomised to receive one of the following treatment arms
• Faslodex (Fulvestrant) 500 mg given as two 5
ml intramuscular injections, one in each
buttock, on days 0, 14, 28 and every 28 days
thereafter ( +/- 3 days )
• PLUS
• Placebo Arimidex (Anastrozole) Tablets 1 mg
once daily, dispensed every 3 months +/- 3
days
• Anastrozole Tablets 1 mg once daily,
dispensed every 3 months (+/- 3 days)
• PLUS
• Faslodex (Fulvestrant) 500 mg given as two 5
ml intramuscular injections, one in each
buttock, on days 0, 14, 28 and every 28 days
thereafter ( +/- 3 days )
D699BC00001 - Packaging
Faslodex kit
• Faslodex ( Fulvestrant) 250mg/5ml solution
for intramuscular injection OR Placebo to
Match
• Castor oil based solution in clear neutral
glass pre-filled syringe
• Dose: 2 x 5ml pre-filled syringes
• 2 Labelled syringes supplied in a labelled
dose carton forming a KIT
• Safety glide needles and instruction leaflet
included in the kit carton where applicable
• Storage conditions “ Store between 2-8°C”
D699BC00001 – Safety Glide Needle Booklet
Countries that can not accept the safety glide needles include Japan and India
Countries included in the booklet
• China
Countries that can accept the safety glide
needles but do not have a specific country
page in the booklet - these countries
could use other country pages with the
same language
• Czech
• Ukraine
• France
• Canada
• Italy
• Peru
• Mexico
• South Africa
• Poland
• Taiwan
• Argentina
• Brazil
• Russia
• Slovakia
• Turkey
• GB
• US
D699BC00001 – Packaging
Arimidex Kit containing 112 Arimidex tablets 1mg or
Placebo
• Arimidex ( Anastrozole)tablets 1mg OR
Placebo Arimidex tablets
• White, round film coated tablet
• Dose: 1 tablet at the same time each day
• Unit of dispensing is a single standard white
HDPE bottle with child resistant closure
• Each bottle contains 112 tablets (12 weeks
supply) forming a KIT
• Storage conditions “ Store below 30°C”
D699BC00001
Labels for randomised packs
All 22 countries will be included in Multi Language Booklet label (MLBL), no tear off
In most cases the local contact details will NOT appear on the individual country pages as this
information will be included in the patient handout
Over printed on front cover:
•
A = Kit ID
•
B = P Lot ID
•
C = Expires End
•
Variable text fields will appear on country specific pages and will vary dependent on
country requirements. These fields should be completed before dispensing to the
patient.
•
Labels displayed below include the Faslodex prefilled syringe, Faslodex carton and
Arimidex bottle
D699BC00001 - Initial site shipments
All sites initially set to low recruitment strategy unless otherwise
specified
Low recruiting sites
•
10 Faslodex kits
•
6 Arimidex kits
Medium recruiting sites
•
12 Faslodex kits
•
10 Arimidex kits
High recruiting sites
•
16 Faslodex kits
•
14 Arimidex kits
Recruitment strategy can be adjusted to medium and high if required
Site resupplies will be generated based on the site stock levels and expected site
recruitment
D699BC00001 - Distribution
Regulatory approval
After Regulatory approval is received and GEL/Slim is updated the following
timelines apply
3 days QA/QP approval
1 day IVRS/IWRS release of packs
1 day IVRS/IWRS consignment generated
Total 5 working days before a consignment will be raised after which kits will be
picked and packed and shipping organised – see shipping timelines
These timelines will increase if the relevant approvals can not be located in
GEL/Slim
Sites will be able to activate at any time but will be unable to enrol any patients
until stock is released and available at the relevant depot.
D699BC00001
Deliveries
Faslodex – shipped as cold shipment at 2 – 8 °C and
Dangerous goods
This will be cold packed and will contain a temperature
monitor which should be stopped and read immediately
after opening the container and transferring the product to
a suitable storage facility
Arimidex shipped as ambient shipment below 30°C and
not temperature monitored unless specifically required for
a country
D699BC00001 - Distribution
One Central Depot – UK ALMAC which will supply the local depots plus the direct to site
shipments
A Blinded Shipment request form will accompany all site deliveries
Countries where ALMAC ship direct to
site
• Countries where we are using Fisher
Local Depots to supply the sites
• Czech
• Argentina
• Italy
• Brazil
• Poland
• China
• Romania
• India
• Slovakia
• Japan
• Spain
• Mexico
• South Africa
• Peru
• UK
• Russia
• Singapore – to supply Taiwan
• Turkey
• Ukraine
• US – also to supply Canada
D699BC00001
Standard Fisher delivery timelines for South American markets
using a depot
Argentina
•
Initial shipment into the depot 92 days
•
Re supply depot shipment 27 days
•
Depot to site shipments 5 days
Brazil
•
Initial shipment into the depot 60 days
•
Re supply depot shipment 35 days
•
Depot to site shipments 5 days
Peru
•
Initial shipment into the depot 39 days
•
Re supply depot shipment 19 days
•
Depot to site shipments 5 days
D699BC00001
Timelines for other markets using a local depot
India
•
Initial shipment into the depot 20 days
•
Re supply depot shipment 15 days
•
Depot to site shipments 5 days
Russia
•
Initial shipment into the depot 39 days
•
Re supply depot shipment 17 days
•
Depot to site shipments 5 days
Turkey
•
Initial shipment into the depot 33 days
•
Re supply depot shipment 14 days
•
Depot to site shipments 4 days
D699BC00001
Timelines for other markets using a local depot
Ukraine
•
Initial shipment into the depot 46 days
•
Re supply depot shipment 22 days
•
Depot to site shipments 4 days
Mexico
•
Initial shipment into the depot 47 days
•
Re supply depot shipment 22 days
•
Depot to site shipments 5 days
Taiwan ( via Singapore depot)
•
Initial shipment into the depot 14 days
•
Re supply depot shipment 19 days
•
Initial Depot to site shipments 49 days. Resupply site shipments 9 days
D699BC00001
Timelines for other markets
US
• Initial and resupply shipments into the depot 16 days
• Receipt into depot 3 days
• Depot to site shipments 4 days
Canada – supplied from US depot
• Initial and resupply shipments into the depot 16 days
• Receipt into depot 3 days
• Depot to site shipments 5 days
Markets supplied direct to site from UK (ALMAC) depot include Italy, Poland,
Slovakia, Spain, South Africa and the UK
• Depot to site shipments 6 days
D699BC00001
Reporting of temperature excursions occurring during Transit
Monitors must be stopped as soon a possible upon receipt and the material unpacked and
placed in the fridge.
Temperature excursion during transit
•
Unpack the consignment as soon as possible after arrival and check the temperature recorder device
has not alarmed.
•
If a temperature excursion has occurred during transit (cross "X" appeared in the top right hand
corner of the display) on confirming the shipment in the IVRS/IWRS answer ‘NO’ to the question ‘was
the shipment received in a usable condition’ .
•
The kits should be quarantined in the correct specified storage conditions for the product e.g. 2 –
8°C for Faslodex/Placebo
•
E-mail pdf to [email protected] and
[email protected] for suitability decision.
•
Title of e-mail should read “D699BC00001-Temperature excursion", site and consignment number
should also be displayed in the e-mail header
See following slide for details of the instructions that may accompany the consignments
D699BC00001
Reporting of temperature excursions occurring at site
•
Change the status of the kits in IVRS to quarantined – See IVRS/IWRS User Manual for details
•
Email sent to [email protected]
•
Title of e-mail should read “D699BC00001-Temperature excursion", site number should also
be displayed in the e-mail header
In order to facilitate a timely response to temperature excursions it is important that the following
information is provided in the email
PLEASE NOTE: A Compliance Issue Notification form is only required when requested to be completed
by AZ.
•
Batch number ( If applicable)
•
Length of excursion
•
Temperatures
•
Kit numbers
All study drug temperature excursions, no matter how small, need to be referred back
immediately for a decision on whether the product is acceptable to use. Normal response is
less then 24 hours unless there is a particularly complicated excursion that needs input from
the AstraZeneca Analysts or GMPQA team
D699BC00001
Expiry Management
• No extension to shelf life is expected during the life of the
trial as Arimidex and Faslodex are both established
commercial products
• Expiry of kits will be managed by the IVRS/IWRS system
D699BC00001
Returns and Destruction

Patients must bring their Arimidex bottles back to the centre at each visit


Drug accountability / compliance checks.
Used / unused pre-filled syringes and bottles, should be destroyed locally at site, after
drug accountability is complete and authorisation by AstraZeneca
D699BC00001
Contacts delivery queries
 Global Logistics Helpdesk details will be provided by Fisher for delivery
queries. This consists of a list of toll free telephone numbers where you will
have a choice of 3 options
 Option 1 – Europe and Africa
 Option 2 – North and South America
 Option 3 – Asia and Australia
 This will divert your call to the relevant helpdesk. A translation service is
available.
 The helpdesk is currently only available 6am to 6pm (GMT) Monday to Friday.
Any queries outside of these hours please send an email to the address below
[email protected]
D699BC00001 Contacts
Supply Chain Study Manager
Janette Downs
[email protected]
+44(0)1625 51 3249