International Conference organised by the
European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe
CERTIFICATION PROCEDURE
1992 - 2012: 20 Years of Experience
22-23 March 2012
Duration: 1.5 days, Location: Palm Beach Hotel, Larnaca, Cyprus
Working language: English
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PROGRAMME
Thursday, 22 March 2012
8:00-9:00 Registration
9:00-9:10 Opening remarks
Dr Susanne Keitel, Director of the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe
Welcome Address
Mr George Antoniou, Ministry of Health, Pharmaceutical Services, Republic of Cyprus
PLENARY SESSION
Moderator: Dr Mike Morris, Chair of the Certification Steering Committee
9:10-9:25 The Evolution of the European Pharmacopoeia and its impact on the Certification procedure
Dr Marianne Ek, Chair of the European Pharmacopoeia Commission
9:25-9:45 New developments in Certification and place of the procedure within the European regulatory framework
Dr Jean-Louis Robert, Chair of the Joint CHMP/CVMP Quality Working Party and Former Chair of the Certification Steering Committee
9:45-10:15 ‘Remember the Pioneers’
Why did we invent the Certification Procedure? - Could not live without it!
Prof. Per Helboe, First Chair of the Technical Advisory Board (TAB) for the Certification Procedure
Where do we stand after 20 years of running the certification procedure? A review
Dr Wilhelm Schlumbohm, Assessor for the Certification Procedure and Former Member of the TAB, BVL, Germany
10:15-10:45 Coffee break
10:45-11:05 Use of CEPs outside Europe: Health Canada’s experience
Dr Amirthini Rajkumar, Health Canada
11:05-11:25 Use of CEPs outside Europe: Therapeutic Goods Administration’s experience
Dr Michael Pass, Therapeutic Goods Administration, Australia
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
Dr Thomas Hecker, Inspector, EDQM, Council of Europe
12:05-12:35 Discussion
12:35 -14:00 Lunch break
WORKSHOP SESSIONS
There will be three parallel workshops (1st Session: 14:00-15:30 and 2nd Session: 16:00-17:30)
You are required to choose two workshops you wish to participate in when registering.
Time / Workshop 1 / Workshop 2 / Workshop 31st Session
14:00-15:30 / Process description and definition of starting materials / The EDQM inspection programme and international collaboration in the area of inspections of API manufacturers / Quality of antibiotics and fermentation products
15:30-16:00 / Coffee Break
2nd Session
16:00-17:30
(Repeated) / Process description and definition of starting materials / The EDQM inspection programme and international collaboration in the area of inspections of API manufacturers / Quality of antibiotics and fermentation products
§ WORKSHOP 1: Process description and definition of starting materials
Moderator: Dr Andrew McMath, Scientific Administrator, EDQM, Council of Europe
o National assessor taking part in Certification
Dr Cornelia Nopitsch Mai, Federal Ministry of Health, Germany
o Industry representative
Mrs Hilde Vanneste, Cefic/APIC
o National Inspector
Mr Lionel Viornery, Afssaps, France
§ WORKSHOP 2: The EDQM inspection programme and international collaboration in the area of inspections of API manufacturers
Moderator: Dr Thomas Hecker, Inspector, EDQM, Council of Europe
o U.S. Food and Drug Administration - FDA
Dr Janice Soreth, Deputy Director, FDA Europe Office, Liaison to EMA
o Therapeutic Goods Administration – TGA – Australian Inspectorate
Mr Bill Turner, Office Head of the Office of Manufacturing Quality
o European Medicines Agency - EMA
Mr Olivier Gross, Scientific Administrator
§ WORKSHOP 3: Quality of antibiotics and fermentation products
Moderator: Mrs Hélène Bruguera, Head of the Certification of Substances Division, EDQM, 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
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
PLENARY SESSION
Moderator: Dr Susanne Keitel, Director, EDQM, Council of Europe
9:00-10:00 9:00-10:00 Feedback from the Workshops
Dr Mike Morris, Chair of the Certification Steering Committee
10:00-11:50 The Interests, Use and Limits of Certificates: Viewpoints from the industry and regulatory authorities
Industry Associations
10:00-10:10 European Federation of the Pharmaceutical Industries and Associations (EFPIA)
Dr Georges France, Vice President Global Quality Strategy & International Affiliate Quality & Compliance (Novartis, Switzerland)
10:10-10:20 European Generic Medicines Association (EGA)
Dr Elli Souli, Regulatory Affairs Supervisor (Medochemie Ltd, Cyprus)
10:20-10:30 Association of the European Self-Medication Industry (AESGP) – Views of the self-care Sector
Dr Christelle Anquez-Traxler, Regulatory and Scientific Affairs Manager (AESGP)
10:30-10:40 European Chemical Industry Council (Cefic) / Active Pharmaceutical Ingredients Committee (APIC)
Mrs Hilde Vanneste, Associate Director Global CMC Regulatory Affairs (Janssen Pharmaceutica NV, Belgium)
10:40-10:50 China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE)
Dr Ming Xu, Vice President (CCCMHPIE)
10:50-11:20 Coffee break
11:20-11:40 Regulatory authorities from Europe
Mr Malcolm Dash, MHRA, United Kingdom
11:40-12:15 Discussion
12:15-12:45 The benefits and cross-functional links between the Certification procedure, the European Pharmacopoeia, the EMA and National Authorities
Dr Jean-Louis Robert, Chair of the Joint CHMP/CVMP Quality Working Party and Former Chair of the Certification Steering Committee
12:50 Close of meeting
13:00 Lunch
For further information, please contact the EDQM Public Relations Division & Documentation:
Mrs F. Baumgarthen, Tel.: +33 (0)3 88 41 28 24 *, Fax: +33 (0)3 88 41 27 71 *,
E-mail:
Postal address: EDQM, 7 allée Kastner, CS 30026, F-67081 Strasbourg, France
* Leave out 0 if calling from outside France