Pistoia Alliance
CSCS Expert Community
meeting
Controlled Substances Compliance Service
GotoMeeting
Wednesday, 30th July 2014
http://pistoiaalliance.org
@PistoiaAlliance
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 2
Update
• Pistoia PM change
• Press Release about Expert Community
Slide 3
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 4
Support new legislation geographies and
legislation types
• Approach
• Chinese legilsation details from GSK
Slide 5
Priority
(MoSCoW)
CSCS Expert Community Goal
Goals + Priorities
Communications and Marketing
–
–
Must
Raise awareness of the issues surrounding interpretation of legislation
Encourage standard terminology usage by regulators, pharma and suppliers
Ambiguous legislation interpretation
–
–
–
Must
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
Identify and define new standards
–
Should
e.g. shipping volume de minimus standards
Define and promulgate a standardised controlled substance terminology
–
Should
Work with relevant bodies to define a standard list of chemical terms
Support new legislation geographies and legislation types
Could
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
Develop compound annotation standards
Generate novel ideas for possible new Pistoia Projects in the
Controlled Substance management area.
Could
Want
Slide 6
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 7
Review /Prioritise the list of legislation for review
Priority Region
Area
USA
barbituric acid derivatives
UK
Proposed new tryptamine definition
USA
France
Guidance on use of the ARCOS listing
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
INCB
Naltrindole
Minimum shipping volumes
Slide 8
Expert Community Website
• http://www.cscs-experts.org
• Would like feedback on style and content
Slide 9
Next Steps/AOB …
• Finalise Charter
• Update the website
• Setup new “project” area
Slide 10