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ASMF-AR – database ad-hoc group on ASMF assessment

ASMF-AR – database ad-hoc group on ASMF assessment. Christa Wirthumer-Hoche Vienna, AT. 28 April 2011 HMA-h. Current ASMF assessment. The same ASMF same AS same manufacturing site same route of synthesis

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ASMF-AR – database ad-hoc group on ASMF assessment

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  1. ASMF-AR – databasead-hoc group on ASMF assessment Christa Wirthumer-Hoche Vienna, AT 28 April 2011 HMA-h

  2. Current ASMF assessment • The same ASMF • same AS • same manufacturing site • same route of synthesis often used in different dossiers for multiple procedures assessed by different assessors. • MRP/DCP • CP • Human/veterinary • Currently there is no Worksharing • Currently there is no common platform for information on ASMFs in Europe • No ASMF-AR database

  3. Ad-hoc group on ASMF assessment • Scope: • Procedural aspects of ASMF assessment • Goal: • To investigate the feasibility - practical and legal aspects of, and consider proposals for: • one central assessment for ASMF going through CP and DCP • a centralised database for all AR of ASMFs • an EU numbering system for ASMFs • To start with a pilot project • Composition of the group: • CMD-h (&v) • Experts from NCAs • CHMP/CVMP (Chair of the QWP) • EMA • EDQM

  4. Ad-hoc group on ASMF assessment • Several issue have been discussed & clarified already, • & • Discussions about a common repository for ASMF-ARs A common ASMF-AR repository may contribute to the reduction of overall workload by • Referring to or • Re-using assessments that already have been made in the EU regulatory network.

  5. Requirements for a common platform • The platform should be designed in such a way that it allows all concerned parties to participate without problems. • The platform should be designed in such a way that it allows data-exchange with other systems. • As far as possible agreed EU-IT interoperability measures as e.g. RDM and EUTCT have to be used. • The platform has to be implemented in a secure way, ensuring that only authorized persons/agencies have access to the system.

  6. AR-submission • In addition to the AR-file(s) the relevant meta-data for the ASMF should be entered • The system should allow for a connection to CTSfor procedural data • Searching: • The system should allow a Google-like search • documents content or • within the attached meta-data.

  7. Hosting the ASMF-AR platform • 2 „friendly volunteers“ are prepared to host the database for ASMF-ARs: • BfArM/DIMDI (within CTS) • EDQM (within the existing EDQM DB) HMA to decide which option to be chosen

  8. Pros & Cons of CTS vs EDQM

  9. HMA decision HMA to decide which option to be chosen for further development • BfArM/DIMDI (within CTS)? • EDQM (within the existing EDQM DB)?

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