Age related activities underway or planned

at MHRA
Nasir Hussain
Specials Population Group, MHRA
Inaugural meeting APS Age Related Medicines Focus Group
London, 30th September 0!3
MHRA Divisional Structure:
VRMM - Special Populations
" ! #i$isions
Licensing
#e$ices e%g% assisti$e technologies, telehealth
&RMM '&igilance and Ris( Management o) Medicines*
" Special Populations '00+*
Director
Dr une Raine
Special
Populations
Dr ulia Dunne
Alternate !HMP Delegate
Strategy " #usiness Manager
Access "
$n%or&ation %or
Medicines "
Standards
Vigilance
$ntelligence "
Researc'
#ene%it(Ris)
Manage&ent
Deputy Director
Dr Sara' #ranc'
Special Populations *
Paediatric +nit ,-.//0
" Implementation o) the Paediatric
Regulation , in )orce since -anuar.
00/
" Rapporteur or Peer Re$ie0er )or
appro$al o) Paediatric In$estigation
Plans submitted to the 1uropean
Medicines Agenc. 'Articles / and 2*
" Re$ie0 o) certain line e3tensions or
$ariations to e3isting mar(eting
authorisations $ia 4M#h51MA
Paediatric sub,group 'Articles 67
and 6+*
!urrent and proposed age-related
&edicines activities
" Paediatric +nit since -.//
"
8omen9s :nit
Pubert.
Pregnanc.
Post,menopausal
" Geriatric Medicines :nit
Face ph.sical and cogniti$e
impairment
4ollation o) material across the
Product Li)e,4.cle Assessment
;eams
" PLA; '1<;*
" PLA; 3 '4<S*
" PLA; + 'Musculos(eletal*
!ontri1ution to t'e 2MA
"
Paediatric Medicines 13pert Ad$isor. Group
"
Geriatric )ormulations concept paper '30
th
-une 0!3*
" 4all )or e3perts )or dra)ting o) the =Re)lection paper on >ualit. aspects o)
medicines )or older people?
"
4ontribution to 0ider net0or(
!% 4@IM1SA 4ross,agenc. group on 4hildren9s Medicines Strateg.
" Responsible )or bringing together rene0ed paediatric strateg. in the
conte3t o) 1: paediatric legislation
" Working sub-group on formulationsA PLA; !,+, Biologics unit, 4;:
!% 4hildren and Coung People9s @ealth Strateg. '#o@*
% Inno$ation D))ice
" Promoting earl. dialogue bet0een inno$ati$e organisations E
companies
" Facilitating understanding o) the regulator. considerations applicable to
their inno$ation