1. D699BC00001(FALCON)
Drug Supply

2. D699BC00001 Contents Trial Design Packaging Labelling Supply Strategy
Distribution
Temperature Excursions
Expiry Management
Returns & Destruction
Contacts

3. 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 )

4. 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”

5. D699BC00001 – Safety Glide Needle Booklet
Countries that can not accept the safety glide needles include Japan and India
Countries included in the booklet
Argentina
Brazil
China
Czech
France
Italy
Mexico
Poland
Russia
Slovakia
Turkey GB US
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
Ukraine
Canada
Peru
South Africa
Taiwan

6. 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”

7. Labels for randomised packs
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

8. 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

9. 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.

10. 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

11. D699BC00001 - Distribution Countries where ALMAC ship direct to site
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
Czech
Italy
Poland
Romania
Slovakia
Spain
South Africa UK
Countries where we are using Fisher Local Depots to supply the sites
Argentina
Brazil
China
India
Japan
Mexico
Peru
Russia
Singapore – to supply Taiwan
Turkey
Ukraine
US – also to supply Canada

12. 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
Peru
Initial shipment into the depot 39 days
Re supply depot shipment 19 days

13. 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
Turkey
Initial shipment into the depot 33 days
Re supply depot shipment 14 days
Depot to site shipments 4 days

14. 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
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

15. D699BC00001 Timelines for other marketsUS
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
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

16. D699BC 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
pdf to and for suitability decision.
Title of should read “D699BC00001-Temperature excursion", site and consignment number should also be displayed in the header
See following slide for details of the instructions that may accompany the consignments
.  

18. 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
sent to
Title of should read “D699BC00001-Temperature excursion", site number should also be displayed in the header
In order to facilitate a timely response to temperature excursions it is important that the following information is provided in the
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

19. D699BC 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

20. Returns and Destruction
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

21. 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 to the address below

22. D699BC00001 Contacts Supply Chain Study Manager Janette Downs
+44(0)