Download Webinar Question Doc_FS_AM_SR

IDMP Webinar 19 January 2017-01-19
Questions answered by Andrew Marr, Frits Stulp and Sergio Rotstein
Q1
Is there a way to extract data from G-SRS (not only few fields but an extended list
of fields)? - Note I used the export feature but I did not get all the fields I wanted...
R1
Andrew: The version of G-SRS available at the moment does not have the full intended
functionality. I’m not aware of the intended capability upon public release, either by FDA
or EMA.
Q2
Is eagle an in-house developed system?
R2
Frits: EAGLE is based on off the shelf software tooling
Q3
What is the requirement for Excipients for IDMP reporting - are these Specified
Substances? What information will need to be reported for these?
R3
Andrew: Excipients are Substances. The data for defining substances does not
differentiate between actives and inactives. A substance is a substance. The grade of a
substance would be defined as a Specified Substance Group 3. The manufacturer of a
substance would be defined as a Specified Substance Group 2. In EU it is anticipated that
the grade of actives and excipients will need to be defined for a Medicinal Product. The
expected position is that the manufacturer of excipients will not need to be required but
this is still to be confirmed.
Q4
What is the requirement for Placebos used in clinical trials?
R4
Andrew: The Medicinal Product standard (ISO11615) supports the definition of placebos
and comparators but the requirements for implementation have not yet been defined.
This may be on a regional basis
Q5
Will the EMA's G-SRS system contain both UNII codes and xEVMPD codes for a
particular substance, and will there be a new identifier generated as part of the
R5
new G-SRS system?
Andrew: The requirements are not yet defined but during the transition period when
both XEVMPD and IDMP are operational, the XEVMPD code will be mapped to the new
IDMP code. There is still need to agree whether the global IDMP code will be the UNII or
a new, additional code.
Q6
For investigational products, at what point would substances be required to be
registered into G-SRS? Is this anticipated to be in line with Patent protection or
R6
Q7
can G-SRS ensure confidentiality?
Andrew: It is anticipated that new substances will need to be registered before First Time
in Man, namely at (or before) the time of CTA/IND. Investigational substances will be
confidential. It is expected that they would only be considered non-confidential if the
structure and company code are put into the public domain within the same publication,
or when a Medicinal Product containing the substance becomes authorised.
Will Regulators or standards organisations be providing more information about
how to link standards like IDMP and eCTD content?
R7
Andrew: From a European perspective there is already a project on-going to look at how
data for IDMP, eAF, CESSP (new common European portal) and eCTD v4 should be
managed as a single data load. EMA will communicate on this at some point in the future,
when plans are more mature
Q8
How do you manage using the same system globally when Controlled
Vocabularies are not standard globally?
R8
Frits: Most of the global systems in Astellas have the required governance in place to
ensure intra-system consistency. The introduction of the new Controlled Vocabulary
Management system and process will now focus on inter-system consistency. Naturally,
where critical processes are concerned now (e.g. between RA and PV) procedural
arrangements are already in place.
Q9
"Mapped where necessary" Can you tell more about this?
R9
Andrew: The ideal is, in the long-term, to have global vocabularies where possible.
However, some vocabularies may not be able to be adopted by all jurisdictions due to
local legislation or current practices. For example, the vocabulary for Pharmaceutical
Dosage Forms as defined by EDQM will be considered to be the ‘global CV’ but FDA, at the
moment is constrained in having to use USP terms. These are being mapped to EDQM
terms so that there is global interoperability.
Q10
Why SRS? Regulators choice?
R10
Andrew: Not sure I understand the question. G-SRS has been a collaboration between
several regulators (US, EU, Canada, Switzerland). It has always been the intent that the
system is to be used in support of IDMP. This does not mean that companies have to
manage their data in a local instance G-SRS, but it is a possibility.
Q11
Where can users gain access to the controlled vocabularies for IDMP?
R11
Andrew: From a European perspective CVs will be made available via the Referential
Management System (RMS) when this goes live (currently expected May 2017). Apart
from being available internally in G-SRS it has not yet been decided how/when CVs for
substances will be made available
Q12
How many votes were included in the first poll?
R12
approx. 80
Q13
How much of the substance data do you see as being exclusively found in
"unstructured" sources, e.g. documents like SmPC.
R13
I think the poll just answered my question!
Q14
Was the CV Management tool at Astellas an off-the-shelf product or home grown?
R14
That slide just answered my question - home grown. Frits: correct; an internal URS
was developed and based on Oracle APEX technology a basic CVM system was
developed, that is likely to be replaced in due course by off the shelf software,
integrating with MDM processes.
Q15
Structured authoring question: is Astellas creating new content in a structured way
or are they using Word documents in i4i and essentially 'tagging' specific content
R15
Q16
to enable extraction and/or consistency?
Frits: At this time the focus is on tagging of relevant components in existing documents so
these can be used for both IDMP submission purposes as well as other business process
objectives (like consistency reporting). For new documents, we intend to introduce the
concepts of structured authoring as much as we can, within the boundaries of the
functionality of our EAGLE system.
Linguamatics have good experience with pharma customers using text mining to
extract IDMP data elements from e.g. SmPCs, eCTDs. How do the panel see this
R16
approach working alongside structured content authoring?
Andrew, Frits
Frits: I have seen interesting examples of this, but overall the required quality control on
the total outcome has never convinced me to fully rely on this so far. I do see great value
in a balanced combination of text mining and structured authoring tools.
Andrew: I’m yet to be convinced that the effort and cost in establishing text mining will be
worthwhile, particularly from documents beyond the SmPC. IDMP increases the need for
closer integration of procedures for managing document and related data content. For a
document such as the SmPC which is data-rich then there can be a role of structured
content authoring, if the size of the company and hence number of SmPCs merits it. The
business case is different for developing documents for new products going forward
versus retro-fitting already authorised products.
Q17
I work in a CMC Product Development analytical lab where we do release and
stability testing of drug substance and tablets used to establish shelf life and
storage conditions for clinical studies. Can you comment on how IDMP will impact
R17
Q18
my work and when the standards relevant to my work will be ratified?
Andrew: I don’t think that they will affect your work. The formulation of product used in
clinical trials will need to be submitted, and perhaps the shelf-life but no data. In the very
long term, the adoption of Specified Substance Group 4, which covers the information
regarding Drug Substance at the level of detail of the CTD would cover analytical methods
and specifications. This is a long way off and, in my opinion, would only be worthwhile
implementing for authorised and not investigational substances.
Are software companies (LIMS, ELN, CDS, MES, etc.) embedding IDMP
standards into their software?
R18
Frits: So far, I have seen very little evidence of that at this time, although it would make so
much sense. Right now the more obvious software suppliers (e.g. RIMS, XEVMPD tooling)
are preparing IDMP readiness in their tools, and some ERP vendors is investigating
combining these requirements with existing traceability functionalities. When timelines
are more firm and the contributions from CMO organizations and internal supply chain
departments become essential, I expect an acceleration in this development. This is my
opinion.
Q19
Would IDMP consider certifying commercial software applications as IDMPcompliant? Then we could buy software off the shelf instead of each of us
R19
spending time and money to create custom solutions.
Andrew, Frits
Frits: I am not clear what is meant with “IDMP” here as this is not an organization. There
have been discussions in seeking a certification from an independent body to describe
coverage of the ISO IDMP requirements in software.
Andrew: It would not be ISO that does any certification. And of course there will be
flavours of IDMP. For example, the scope, processes, some vocabularies etc will vary
between regulators implementing IDMP.
Q20
Will a recording of the webinar be made available?
R20
Yes, it will be uploaded tomorrow
Q21
I would like to know if we could get the slides after the end of the meeting
R21
They'll be posted on our website tomorrow.
Q22
Is there way of representing mutant proteins that may be therapeutic.
R22
Sergio: From a HELM perspective the answer is yes. Any kind of protein can be
represented, including any that may have any kind of unnatural component (e.g.
Unnatural amino acids, chemical attachments, etc)