D699BC00001(FALCON) Drug Supply. D699BC00001 Trial Design Packaging Labelling Supply Strategy...

D699BC00001(FALCON)Drug Supply

D699BC00001

Trial Design

Packaging

Labelling

Supply Strategy

Distribution

Temperature Excursions

Expiry Management

Returns & Destruction

Contacts

Contents

D699BC00001Trial DesignRandomised, 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

• 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 )

• 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

D699BC00001 - PackagingFaslodex 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 BookletCountries that can not accept the safety glide needles include Japan and India

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

Countries included in the booklet

• Argentina

• Brazil

• China

• Czech

• France

• Italy

• Mexico

• Poland

• 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 packsAll 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

Low recruiting sites

• 10 Faslodex kits

• 6 Arimidex kits

Medium recruiting sites


• 10 Arimidex kits

High recruiting sites


• 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

All sites initially set to low recruitment strategy unless otherwise specified

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 - DistributionOne 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 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

Countries where ALMAC ship direct to site

• Czech

• Italy

• Poland

• Romania

• Slovakia

• Spain

• South Africa

• UK

D699BC00001Standard 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




Peru




D699BC00001Timelines for other markets using a local depot

India




Russia




Turkey




D699BC00001Timelines for other markets using a local depot

Ukraine




Mexico




Taiwan ( via Singapore depot)



• Initial Depot to site shipments 49 days. Resupply site shipments 9 days

D699BC00001Timelines for other markets

US

• Initial and resupply shipments into the depot 16 days

• Receipt into depot 3 days


Canada – supplied from US depot

• Initial and resupply shipments into the depot 16 days

• Receipt into depot 3 days


Markets supplied direct to site from UK (ALMAC) depot include Italy, Poland, Slovakia, Spain, South Africa and the UK


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

• .

mailto:[email protected]


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

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

Returns and Destruction

D699BC00001Contacts 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


D699BC00001(FALCON) Drug Supply. D699BC00001 Trial Design Packaging Labelling Supply Strategy...

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