http://pistoiaalliance.org @PistoiaAlliance

Pistoia AllianceCSCS Expert Community meetingControlled Substances Compliance Service

GotoMeetingWednesday, 30th July 2014

Slide 2

Agenda

Time Activity

15:00 - 15:10 Update

15:10 - 15:40 Communications

15:40 – 15:55 Support new legislation geographies and legislation types

15:55 – 16:20 Review /Prioritise the list of legislation for review

16:20 - 16:25 Expert Community Website

16:25 - 16:30 AOB

Slide 3

Update

• Pistoia PM change• Press Release about Expert

Community

Slide 4

Communications

• Expert Community name• Miptec Conference• CSCS project article for Drug

Discovery Today • Legislation watch

– providing a reader-friendly context for any new legislation but it would also provide an opportunity to comment on what we perceive to be the scope of the particular piece of legislation.

–

Slide 5

Support new legislation geographies and legislation types

• Approach• Chinese legilsation details from GSK

Slide 6

Goals + PrioritiesCSCS Expert Community Goal Priority

(MoSCoW)

Communications and Marketing– Raise awareness of the issues surrounding interpretation of legislation – Encourage standard terminology usage by regulators, pharma and suppliers

Must

Ambiguous legislation interpretation– Identify and prioritise legislation which requires clarification– Establish and maintain a common communication channel to regulatory

agencies• Seek, document and share clarification of ambiguous legislation• If there is no clarification from a regulatory agency then the Expert

Community will agree a standard working definition for the ambiguous legislation

– Share expertise on interpretation of legislation across different regions

Must

Identify and define new standards – e.g. shipping volume de minimus standards

Should

Define and promulgate a standardised controlled substance terminology

– Work with relevant bodies to define a standard list of chemical terms

Should

Support new legislation geographies and legislation types

This will require detailed expertise covering the geographies/legislation under consideration, if sufficient funds are raised a RFP process will be undertaken.

– Scope work and raise funding – Build test datasets

• Build independent test datasets, this would allow customers to check a vendor’s system and data.

– Translation of legislation

Could

Develop compound annotation standards CouldGenerate novel ideas for possible new Pistoia Projects in the Controlled Substance management area.

Want

Slide 7

Legislation Review Process

• maintain a list on the website but detailed decisions will be held in Pistoia Project area which will only be available to the Expert Community members.

• Ambiguous legislation review method– Experience legislators more likely to give feedback

on specific structures e.g. UK home Office on Parahexyl

– We do have some feedback from UK Home office which can be shared with the Expert Community

• How do we manage contact with the Regulators ?

Slide 8

Review /Prioritise the list of legislation for review

Priority

Region Area

  USA barbituric acid derivatives

UK Proposed new tryptamine definition  USA Guidance on use of the ARCOS listing  France Harmaline, Hydrochloride (1:1) / Harmalol, Hydrochloride (1:1)

Salts not mentioned in legislation but salts included for other compounds nearby

  Switzerland only ethers or esters of List A or B are considered as narcotics or psychotropic substances, i.e. not those of List E

  Switzerland List e (raw materials): 3-(naphthoyl)pyrrole derivative (N-substitution) (general question: should derivatives of raw materials also be controlled?)

  USA/UK SILANDRONE should silyl ethers to be included In the definition of ‘ether’, using the logic that the ether links can normally be cleaved

  INCB ? Ether Derivatives

  INCB ? Ester Derivatives

  USA Naltrindole  INCB Minimum shipping volumes

Slide 9

Expert Community Website

• http://www.cscs-experts.org• Would like feedback on style and

content

Slide 10

Next Steps/AOB …

• Finalise Charter• Update the website• Setup new “project” area