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International Conference organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe E
R CERTIFICATION PROCEDURE U
D 1992 - 2012: 20 Years of Experience
E 22-23 March 2012 C
O Duration: 1.5 days, Location: Palm Beach Hotel, Larnaca, Cyprus R
s Working language: English P u
r *** p N
y PROGRAMME O C I
, Thursday, 22 March 2012 T a c A a
C 8:00-9:00 Registration n I r F a I
L 9:00-9:10 Opening remarks
T , l Dr Susanne Keitel, Director of the European Directorate for the Quality of R e t
E Medicines & HealthCare (EDQM), Council of Europe o C H
Welcome Address h E Mr George Antoniou, Ministry of Health, Pharmaceutical Services, Republic of c H a Cyprus e T
B
N m
l PLENARY SESSION O
a Moderator: Dr Mike Morris, Chair of the Certification Steering Committee P E
: C
n 9:10-9:25 The Evolution of the European Pharmacopoeia and its impact on the N o i
E Certification procedure t R
a Dr Marianne Ek, Chair of the European Pharmacopoeia Commission E c F o 9:25-9:45 New developments in Certification and place of the procedure within the L N European regulatory framework – O
C Dr Jean-Louis Robert, Chair of the Joint CHMP/CVMP Quality Working Party
2
L and Former Chair of the Certification Steering Committee 1 A 0 N
2 9:45-10:15 ‘Remember the Pioneers’
O Why did we invent the Certification Procedure? - Could not live without it! I H
T Prof. Per Helboe, First Chair of the Technical Advisory Board (TAB) for the C
A Certification Procedure R N Where do we stand after 20 years of running the certification procedure? A A R review E M
T Dr Wilhelm Schlumbohm, Assessor for the Certification Procedure and Former 3 N
I Member of the TAB, BVL, Germany 2
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E 2 10:15-10:45 Coffee break 2 M
M 10:45-11:05 Use of CEPs outside Europe: Health Canada’s experience
A Dr Amirthini Rajkumar, Health Canada
R
G 11:05-11:25 Use of CEPs outside Europe: Therapeutic Goods Administration’s experience O Dr Michael Pass, Therapeutic Goods Administration, Australia R P 11:25-11:45 Inspections of API manufacturers: What is new? What are the new challenges to face? Opportunities of international collaboration Mr Olivier Gross, Scientific Administrator, EMA
11:45-12:05 Inspections of API manufacturers: Experience of the EDQM E R U D E C O R s P u
r p N y O C I
, T a c A a C n I r F a I L
T , l R e t E o C H
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Dr Thomas Hecker, Inspector, EDQM, Council of Europe
E 12:05-12:35 Discussion R 12:35 -14:00 Lunch break U D
E WORKSHOP SESSIONS C There will be three parallel workshops (1st Session: 14:00-15:30 and 2nd Session: 16:00-17:30) O
R You are required to choose two workshops you wish to participate in when registering. s P u
r p N y
O Time Workshop 1 Workshop 2 Workshop 3 C I
, T
a The EDQM inspection c A
a programme and C
n st Process description I
r 1 Session international Quality of antibiotics and F a and definition of I
L 14:00-15:30 collaboration in the fermentation products
T , starting materials l area of inspections of R e t
E API manufacturers o C H
h 15:30-16:00 Coffee Break E c H a
e The EDQM inspection T
B nd programme and N 2 Session Process description m
l international Quality of antibiotics and O
a 16:00-17:30 and definition of collaboration in the fermentation products P E
(Repeated) starting materials :
C area of inspections of n
N API manufacturers o i E t R a
E . WORKSHOP 1: Process description and definition of starting materials c F o Moderator: Dr Andrew McMath, Scientific Administrator, EDQM, Council of Europe L N
o National assessor taking part in Certification – O
Dr Cornelia Nopitsch Mai, Federal Ministry of Health, Germany C
2 Industry representative
L o 1 A
0 Mrs Hilde Vanneste, Cefic/APIC N 2 o National Inspector
O I
H Mr Lionel Viornery, Afssaps, France T C A
R .WORKSHOP 2: The EDQM inspection programme and international collaboration in N A
R the area of inspections of API manufacturers E M Moderator: Dr Thomas Hecker, Inspector, EDQM, Council of Europe
T
3 o U.S. Food and Drug Administration - FDA N I 2 Dr Janice Soreth, Deputy Director, FDA Europe Office, Liaison to EMA - :
E 2 o Therapeutic Goods Administration – TGA – Australian Inspectorate 2 M Mr Bill Turner, Office Head of the Office of Manufacturing Quality
M o European Medicines Agency - EMA A Mr Olivier Gross, Scientific Administrator R
G
O . WORKSHOP 3: Quality of antibiotics and fermentation products
R Moderator: Mrs Hélène Bruguera, Head of the Certification of Substances Division, EDQM, P Council of Europe o Quality of fermentation products Prof. Jos Hoogmartens, Chair of the EDQM Group of Experts on Antibiotics o New EU Guideline on antibiotics Dr Tone Agasoster, Norwegian Medicines Agency E R U D E C O R s P u
r p N y O C I
, T a c A a C n I r F a I L
T , l R e t E o C H
h E c H a e T
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N m l O
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: C n N o i E t R a E c F o N L
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o European Pharmacopoeia (Ph. Eur.) monographs for fermentation products Dr Jan W. H. Smeets, Expert of the EDQM Group of Experts on Antibiotics Friday, 23 March 2012 E
R PLENARY SESSION
U Moderator: Dr Susanne Keitel, Director, EDQM, Council of Europe D E
9:00-10:00C 9:00-10:00 Feedback from the Workshops
O Dr Mike Morris, Chair of the Certification Steering Committee R s P u
r 10:00-11:50 The Interests, Use and Limits of Certificates: Viewpoints from the p N
y industry and regulatory authorities O C I
, T a Industry Associations c A a
C 10:00-10:10 European Federation of the Pharmaceutical Industries and Associations (EFPIA) n I r , Vice President Global Quality Strategy & International
F Dr Georges France a I L
Affiliate Quality & Compliance (Novartis, Switzerland) T , l R e 10:10-10:20 European Generic Medicines Association (EGA) t E
o Dr Elli Souli, Regulatory Affairs Supervisor (Medochemie Ltd, Cyprus) C H
10:20-10:30 Association of the European Self-Medication Industry (AESGP) – Views of the h E
c self-care Sector H a
e Dr Christelle Anquez-Traxler, Regulatory and Scientific Affairs Manager T
B
(AESGP) N m
l 10:30-10:40 European Chemical Industry Council (Cefic) / Active Pharmaceutical Ingredients O
a Committee (APIC) P E
:
C Mrs Hilde Vanneste, Associate Director Global CMC Regulatory Affairs (Janssen n
N Pharmaceutica NV, Belgium) o i E
t 10:40-10:50 China Chamber of Commerce for Import & Export of Medicines & Health R a Products (CCCMHPIE) E c F
o Dr Ming Xu, Vice President (CCCMHPIE) L N
– O
10:50-11:20 Coffee break C
2 L 1 11:20-11:40 Regulatory authorities from Europe A 0 N
2 Mr Malcolm Dash, MHRA, United Kingdom
O I H
T 11:40-12:15 Discussion C A R N 12:15-12:45 The benefits and cross-functional links between the Certification procedure, A R the European Pharmacopoeia, the EMA and National Authorities E M
T Dr Jean-Louis Robert, Chair of the Joint CHMP/CVMP Quality Working Party 3 N
I and Former Chair of the Certification Steering Committee 2
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E 2
2 12:50 Close of meeting M M 13:00 Lunch A
R
G For further information, please contact the EDQM Public Relations Division & Documentation: O Mrs F. Baumgarthen, Tel.: +33 (0)3 88 41 28 24 *, Fax: +33 (0)3 88 41 27 71 *, R E-mail: [email protected] P Postal address: EDQM, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France
* Leave out 0 if calling from outside France