Upload
ngokiet
View
226
Download
2
Embed Size (px)
Citation preview
SPEAKERS:
Boris PimentelPi-Consulting, Switzerland
Cristian SampaolesiEuropean Directorate for the Quality of Medicines (EDQM & Health Care), France
Wilhelm SchlumbohmBerlin, Germany
Jan SmeetsDSM Sinochem Pharmaceuticals, The Netherlands
PROGRAMME:
� Dossier Requirements for the Drug Substance
� How to Compile an ASMF
� Requirements for the Certificate of Suitability
� Drug Substance - Setting Specifica-tions
� Stability Data
� Description of the Manufacturing Process and Process Controls
� Impurities and Residual Solvents
� Handling of Variations/Changes in Europe and the US
� Registration Requirements in Emerging Countries
� Comparison of CEP and ASMF Procedure
CTD, CEP and Active Substance Master File
Quality of Drug Substance
1-2 March 2016, Prague, Czech Republic
wa/vers1/24062015 This education course is recognised for the ECA GMP Certification Programme „Certified Regulatory Affairs Manager“. Please find details at www.gmp-certification.eu
Choose 2 out of 4 Parallel Workshops � Stability Studies and Establishing the Retest Date � Description of the Manufacturing Process � How to Compile Data for Impurities and Residual
Solvents � Questions and Answers of the CEP Procedure
Objectives
This education course is intended to provide guidance on the format, content and submission procedures for the pharmaceutical documentation of the quality of the drug substance for different types of dossiers, the CTD, the CEP and the European ASMF and the US-DMF. Fur-thermore, the impact of the variations regulations will be discussed.
Participants will have the opportunity to choose 2 out of 4 parallel workshops:
� Stability studies and establishing a retest date � Description of the manufacturing process � How to compile data for impurities and residual
solvents � Questions and answers of the CEP procedure
Background
In Europe there are several ways to document the quality of the drug substance for the purpose of marketing au-thorisation:
� Certificate of Suitability of the pharmacopoeial monograph (CEP)
� Full details of manufacture (according to CTD Module 3 Quality of Drug Substance)
� European Active Substance Master File (ASMF; former Drug Master File, DMF)
� Other evidence of suitability of the pharmacopoeial monograph
In the US, the quality of the drug substance can be docu-mented as part of the CMC Dossier or in a US-DMF.
Target Group
The education course is designed for all persons in-volved in the compilation of pharmaceutical dossiers for marketing authorisations who want to become familiar with the different ways to document the quality of the drug substance for the purpose of marketing authorisa-tion in Europe. Furthermore, the course will be of interest to personnel from Quality Units of the pharmaceutical and the API industry.
Social Event
On 1 March, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from oth-er companies in a relaxed atmosphere.
Programme
General Part
Dossier Requirements for the Drug Substance – An Introduction
� Chemical pharmaceutical documentation for active substance(s) – Regulatory requirements in EU, USA
� Types of active substances – types of documentation � CTD Module 3, CEP and ASMF (former DMF) � CEP for a substance for TSE risk assessment
How to Compile an ASMF Using the CTD Format � Structure of the ASMF � Compilation of an ASMF; how to start � Compilation steps and technical approaches � ASMF and eCTD � eCTD vs. NEES � DMF systems in the US, Japan and Latin America
Requirements for the Certificate of Suitability � Regulatory basis: Resolution AP-CSP (99)4 of the
Council of Europe � CEP Procedure � Content of the CEP dossier with practical examples � Administrative minor and major changes, 5 year’s
revision
Special Part
Stability Data � CPMP/ICH Guidelines � Stability Summary and Conclusions, stability
commitment � Documentation of Stability Data � Necessity for documentation of raw data?
Description of the Manufacturing Process and Process Controls
� The regulatory framework for manufacturing APIs � Most frequent issues on manufacturing process
description � Format and content of the MP Chapter CTD-3.2.S-2 � The CTD Module 3– Quality: 3.2.S.2 � Critical issues in the process description � CEP specific requirements
Impurities and Residual Solvents � CPMP/ICH Guidelines Impurities and Residual
Solvents � Specifying Impurities � Classifying solvents, setting and proving limits � Justification of Specification
Registration requirements in emerging countries
CTD, CEP and Active Substance Master File
1-2 March 2016, Prague, Czech Republic
Regulatory Compliance
Handling of Variations/Changes in Europe and the US � The EU Variations Regulation and detailed
Guidelines � Types of Changes � Remaining problems of changes for the API Industry � Change system for APIs in EU � Change System for APIs in USA � New FDA initiatives to facilitate changes � Preferred options for Bulk Pharmaceutical Industry to
solve post-approval change problems � How to handle variations in the ASMF and the CEP
procedure
Comparison of CEP and ASMF Procedure � Advantages of the CEP procedure � Handling Changes � In which countries is the CEP being accepted? � Cost Considerations � Practical examples
Parallel Workshops
Please choose two out of four parallel workshops
Stability Studies and Establishing the Retest DateDr Jan Smeets
Description of the Manufacturing ProcessDr Wilhelm Schlumbohm
How to Compile Data for Impurities and Residual SolventsDr Boris Pimentel
Questions and Answers of the CEP ProcedureFiona McLeod
Important: In order to prepare the lectures and the workshops in an optimal way, please send your ques-tions to special topics to Dr Gerhard Becker, email: [email protected]. He will forward your questions to the responsible speaker. Thank you in ad-vance for your cooperation.
Speakers
Dr Boris PimentelPi-Consulting, SwitzerlandDr Pimentel is manager of the consulting company for global regulatory services – Pi-Consulting in Switzerland. Until June 2014 he worked on the Dutch company DSM
Nutritional Products in Switzerland, focusing in Pharma and Food regulations. Since 2010 as a member of the APIC board he was involved in several task forces like ASMFs, Variations and Changes, and participated in the discussions with EMA, WHO and EDQM. He also chaired the task force for Japan regulations, and Emerging Market Regulations.
Cristian SampaolesiCertification Division, European Directorate for the Quality of Medicines (EDQM & Health Care), France
Dr Wilhelm SchlumbohmBerlin, GermanyDr Schlumbohm worked more than 20 years with German drug licensing authorities in the field of assessment of the CMC parts of new drug applications. He is expert for the Certifi-
cation Procedure of the European Pharmacopoeia.
Dr Jan SmeetsDSM Sinochem Pharmaceuticals, The Netherlands 10 years with Gist-brocades, 12 years with DSM and now with DSM Sinochem Pharma-ceuticals with different positions in Research
& Development, Regulatory Affairs and Technical Sales Services for APIs and intermediates. Currently Director Regulatory Affairs & Technical Sales Services. Responsible for worldwide submissions and regulatory approvals. Dutch representative in group 7 (antibiotics) of the European Pharmacopoeia.
Rese
rvat
ion
Form
(Ple
ase
com
ple
te in
full)
CTD
, CEP
an
d A
ctiv
e Su
bst
ance
Mas
ter F
ile,
1-2
Mar
ch 2
016
, Pra
gue,
Cze
ch R
epub
lic
*
Mr.
*M
s. Ti
tle, fi
rst n
ame,
sur
nam
e
Co
mp
any
Dep
artm
ent
Imp
ort
ant:
Ple
ase
ind
icat
e yo
ur c
om
pan
y’s
VA
T ID
Nu
mb
er
Pu
rch
ase
Ord
er N
o, i
f ap
plic
able
Str
eet/
P.O
. Box
City
Z
ip C
od
e C
oun
try
Pho
ne/F
ax
E-M
ail (
ple
ase
fill i
n)
Date
Tuesday, 1 March 2016, 9.00 h– 18.15 h(Registration and coffee 8.30 h – 9.00)Wednesday, 2 March 2016, 8.30 h– 16.00 h
Venue
Corinthia Hotel PragueKongresova 114069 Prague 4, Czech RepublicPhone +420 (261) 191 111Fax +420 (261) 225 011
Fees (per delegate plus VAT)
ECA Members € 1,590APIC Members € 1,690Non-ECA Members € 1,790EU GMP Inspectorates € 895The fee is payable in advance after receipt of invoice and includes conference documentation, social event and dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
Accommodation
CONCEPT has reserved a limited number of rooms in the conference hotel. You will receive a room reserva-tion form when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Conference language
The official conference language will be English.
Organisation and Contact
ECA has entrusted Concept Heidelberg with the organisation of this event.
CONCEPT HEIDELBERGP.O. Box 10 17 64D-69007 Heidelberg, GermanyPhone +49 (0) 62 21/84 44-0Fax +49 (0) 62 21/84 44 [email protected]
For questions regarding content:Dr Gerhard Becker (Operations Director) at +49 (0) 62 21 / 84 44 65, or per e-mail at [email protected].
For questions regarding reservation, hotel, organisation etc.:Ms Susanne Ludwig (Organisation Manager) at +49 (0) 62 21 / 84 44 44, or per e-mail at [email protected].
If th
e b
ill-t
o-a
dd
ress
dev
iate
s fr
om
the
spec
ifica
tions
on
the
right
, p
leas
e fil
l out
her
e:
C
ON
CEP
T H
EID
ELBE
RG
P.O
. Box
1017
64
Fax
+49
(0) 6
2 21
/84
44 3
4
D
-690
07
Hei
del
ber
g
GER
MA
NY
+
49
6221
84
44 3
4 Easy Registration
Reservation Form:CONCEPT HEIDELBERGP.O. Box 10 17 6469007 HeidelbergGermany
Reservation Form:+ 49 6221 84 44 34 @ e-mail:
[email protected] Internet:www.gmp-compliance.org
wa/vers1/24062015Gen
eral
term
s an
d c
ond
itio
nsIf
you
cann
ot a
ttend
the
conf
eren
ce y
ou h
ave
two
optio
ns:
1. W
e ar
e ha
ppy
to w
elco
me
a su
bst
itute
col
leag
ue a
t any
tim
e.2.
If y
ou h
ave
to c
ance
l ent
irely
we
mus
t cha
rge
the
follo
win
g p
roce
ssin
g fe
es: C
ance
llatio
n -
until
2 w
eeks
prio
r to
the
conf
eren
ce 10
%,
- un
til 1
wee
ks p
rior t
o th
e co
nfer
ence
50
%-
with
in 1
wee
k pr
ior t
o th
e co
nfer
ence
100
%.
CO
NC
EPT
HEI
DEL
BERG
rese
rves
the
right
to c
hang
e th
e m
ater
ials
, in-
stru
ctor
s, o
r spe
aker
s w
ithou
t not
ice
or to
can
cel a
n ev
ent.
If th
e ev
ent
mus
t be
canc
elle
d, r
egis
tran
ts w
ill b
e no
tified
as
soon
as
poss
ible
and
w
ill re
ceiv
e a
full
refu
nd o
f fee
s pa
id. C
ON
CEP
T H
EID
ELBE
RG w
ill n
ot
be
resp
onsi
ble
for d
isco
unt a
irfar
e p
enal
ties
or o
ther
cos
ts in
curr
ed
due
to a
can
cella
tion.
Te
rms
of p
aym
ent:
Pay
able
with
out d
educ
-tio
ns w
ithin
10 d
ays
afte
r rec
eipt
of i
nvoi
ce.
Imp
ort
ant:
Thi
s is
a b
ind
ing
regi
stra
tion
and
ab
ove
fees
are
due
in
case
of c
ance
llatio
n or
non
-app
eara
nce.
If y
ou c
anno
t tak
e pa
rt,
you
have
to in
form
us
in w
ritin
g. T
he c
ance
llatio
n fe
e w
ill th
en b
e ca
lcul
ated
acc
ord
ing
to th
e po
int o
f tim
e at
whi
ch w
e re
ceiv
e yo
ur
mes
sage
. In
case
you
do
not a
ppea
r at t
he e
vent
with
out h
avin
g in
form
ed u
s, y
ou w
ill h
ave
to p
ay th
e fu
ll re
gist
ratio
n fe
e, e
ven
if yo
u ha
ve n
ot m
ade
the
paym
ent y
et. O
nly
afte
r we
have
rece
ived
yo
ur p
aym
ent,
you
are
entit
led
to p
artic
ipat
e in
the
conf
eren
ce
(rec
eipt
of p
aym
ent w
ill n
ot b
e co
nfirm
ed)!
(As
of Ja
nuar
y 20
12)
Priv
acy
Polic
y: B
y re
gist
erin
g fo
r thi
s ev
ent,
I acc
ept t
he p
roce
ssin
g of
my
Pers
onal
Dat
a. C
once
pt H
eid
elb
erg
will
use
my
dat
a fo
r the
pr
oces
sing
of t
his
ord
er, f
or w
hich
I he
reb
y d
ecla
re to
agr
ee th
at m
y pe
rson
al d
ata
is s
tore
d a
nd p
roce
ssed
. Con
cept
Hei
del
ber
g w
ill o
nly
send
me
info
rmat
ion
in re
latio
n w
ith th
is o
rder
or s
imila
r one
s. M
y pe
rson
al d
ata
will
not
be
dis
clos
ed to
third
par
ties
(see
als
o th
e pr
i-va
cy p
olic
y at
http
://w
ww
.gm
p-co
mpl
ianc
e.or
g/ec
a_pr
ivac
y.ht
ml).
I n
ote
that
I ca
n as
k fo
r the
mod
ifica
tion,
cor
rect
ion
or d
elet
ion
of m
y d
ata
at a
ny ti
me
via
the
cont
act f
orm
on
this
web
site
.
#
Plea
se c
hoo
se T
WO
wo
rksh
op
s:
�St
abili
ty s
tud
ies
and
est
ablis
hing
the
rete
st d
ate
�
Des
crip
tion
of t
he m
anuf
actu
ring
pro
cess
�
Ho
w to
co
mp
ile d
ata
for i
mp
uriti
es a
nd re
sid
ual s
olv
ents
�
Que
stio
ns a
nd a
nsw
ers
of t
he C
EP p
roce
dur
e