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GMP Conference9-10 October 2006
Regulatory Affairs Conference10-11 October 2006
9th APIC/CEFIC European Conference on
Active Pharmaceutical Ingredients9-11 October 2006, Prague, Czech Republic
A Sector Group of
Industry Speakers confirmed:
5 % early-bird discount if
you register until
30 March 2006
Moheb Nasr, CDER, FDA, USA
Authority Speakers confirmed:
John Berridge, Pfizer, UKDr Nandkumar Chodankar,Sekhsaria Chemicals, IndiaMarieke van Dalen, Diosynth, The NetherlandsBarbara Lani, Bracco, ItalyHenri Leblanc, Rhodia Chimie, FranceWendy Mavroudakis, Johnson&Johnson, USAJim McKiernan,McKiernan Ass., SwitzerlandGerald Migliaccio, Pfizer, USAJan Moors, Teva / PCH Pharmachemie, The NetherlandsPieter Rouwette, Solvay Pharmaceuticals, BelgiumJan Smeets, DSM Anti-Infectives, The NetherlandsMarten Wiersma, NV Organon, The Netherlands
9th APIC/CEFIC European Conference on
Active Pharmaceutical Ingredients
Conference Programme
This year, the 9th APIC/CEFIC European Conferenceon Active Pharmaceutical Ingredients will take placein Prague / Czech Republic.
“ Maybe there has never been a better moment in timefor an API Conference than October 2005!” is what wewrote in our last year’s conference brochure.The liveliness and outcome of the Berlin event andthe extensive publicity it received thereafter fullyconfirmed that this was not an overstatement.But regulatory reality does not change overnight.
If you want to be updated fully, then attending the 9th
APIC/CEFIC Conference on APIs is a must.Moreover, we have carefully selected top speakerswho are active as decision makers within thecomplex, ongoing process of regulatory change.
A special feature of the joint day will be 8 parallelsessions on GMP and Regulatory Affairs. Participantshave the opportunity to choose between differenttopics.
The conference will allow enough time fornetworking with other colleagues to exchangeinformation about best practices among industryrepresentatives. You will also be able to get intocontact with high ranking officials from EU, FDA andinspectors.
Social Event on 9 October
The social event has become a tradition and was wellappreciated during the past conferences (in Brussels,Hamburg, Vienna, Barcelona, Budapest, Lisbon and Berlin).We will continue this tradition in Prague and invite allparticipants and speakers to an entertaining eveningoutside the hotel followed by a dinner.
GMP ConferenceObjectiveIn the EU the new API legislation on GMP and itssupporting guidelines and systems are in the processof transformation from being written words only tobecoming reality. Audits, inspections, certifications… where will we stand in October 2006?
And how do the new requirements impact on amajor API producing country such as e.g. India?
Meanwhile the developments on regulatory reformare continuing in the USA. But during the past year ithas become clear that these developments aregetting more and more a global character with e.g.the EU having dropped its initially hesitant attitudetowards ICH Q10.
So ICH is reinforcing its key role in InternationalHarmonization, now also in the arena of RegulatoryReform. By attending the GMP Conference you willget an update on the latest development from thedecision makers in Europe and US.
nn One Year after Implementation of the New EUAPI Legislation: An Update from EMEA
nn One Year after Implementation of the New EUAPI Legislation: An Industry View on andExperiences With the Current System andProcedures for API Inspections and AuditingJan Moors
nn cGMP Lifecycle Approach for Validation in the21st Century
nn How to Implement ICH Q9 into an API PlantBarbara Lani
nn ICH Q10 – Status Quo
Joint GMP andRegulatory Affairs Day
Parallel Sessions I
Session 1:APIC Guide on Quality Management
Session 2:Riskbased Approach for Equipment QualificationPieter Rouwette
Session 3:Critical Quality Attributes in a Multi CustomerEnvironmentHenri Leblanc
Session 4:How to establish a 6 Sigma Concept in an API PlantJim McKiernan
Parallel Sessions II
Session 5:A new API Powder Processing Facility RegulatoryAspects
Session 6:How to define the API Starting Material – Case Studies
Session 7:API Dossier Requirements in JapanMarieke van Dalen
Session 8:Biotech Topic
nn ICH Q8 – What is Relevant for APIsJohn Berridge
nn Quality by Design: An Industry View on How ICHQ8 Translates into Industrial API Practice andIncreased Regulatory FlexibilityWendy Mavroudakis
nn PAT
nn Impact of European Legislation on Indian/ChineseAPI Manufacturers
Regulatory AffairsConferenceObjectiveFor API manufacturers, Regulatory Affairs (RA) is oftenstill a problem area. This situation has not improved inthe past years and has even become more difficult. TheRA topics of the conference will include problems withand possible solutions for the postapprovalauthorisation of changes / improvements in APImanufacture. Of course, ICH Q8, Q9 & Q10 as well asRA aspects of FDA’s 21st Century Initiative are items onthe program. The running and new activities of theEMEA Quality Working Party will be highlighted and anupdate on new developments regarding the CEPprocedure will be presented. Also, options for the moretransparent development of new regulations andguidance will be discussed.
nn FDA’s Latest Quality Assessment IssuesMoheb Nasr
nn ImpuritiesJan Smeets
nn New Developments regarding the CEP Procedure& the EDQM/OMCL Testing Programme for APIson the European Market
nn Revision of the Variations RegulationsMike J. James
nn Closing RemarksHenri Leblanc
Conference Exhibition
Would you also like to present an exhibition stand?And have your company listed in the conferenceprogramme? Please contact Ms Marion Grimm,phone + 4962 21 / 84 44 18,email: grimm@conceptheidelberg.de
About CEFICCEFIC, the European Chemical Industry Council, is theBrusselsbased organisation representing nationalchemical federations and chemical companies of Europe.All in all, CEFIC represents, directly or indirectly, morethan 29,000 large, medium and small chemicalcompanies in Europe, which employ about 1.7 millionpeople and account for nearly one third of worldchemical production.
SpeakersMr John Berridge, Pfizer, UKDr Nandkumar Chodankar, Sekhsaria Chemicals Ltd., IndiaMs Marieke van Dalen, Diosynth B.V., The NetherlandsMs Barbara Lani, Bracco, ItalyDr. Henri Leblanc, Rhodia Chimie, FranceMrs Wendy Mavroudakis, Johnson&Johnson, USAMr Jim McKiernan, McKiernan Ass., SwitzerlandDr. Gerald Migliaccio, Pfizer, USMr Jan Moors, Teva / PCH Pharmachemie, The NetherlandsDr Moheb Nasr, CDER, FDA, USAMr Pieter Rouwette, Solvay Pharmaceuticals, BelgiumDr. Jan Smeets, DSM AntiInfectives, The NetherlandsDr Marten Wiersma, NV Organon, The Netherlands
ChairmenMr Paul Michielsens, Solvay Pharmaceuticals, BelgiumMr Matt Moran, Pharma Chemical IrelandDr Chris Oldenhof, DSM AntiInfectives, The Netherlands
Steering CommitteeWe would like to express our sincere gratitude to themembers of the steering committee for developing theconference:Mr Pieter van der Hoeven, CEFIC, BelgiumDr Barbara Jentges, Concept Heidelberg, GermanyDr Henri Leblanc, Rhodia Organique, FranceMr Paul Michielsens, Solvay Pharmaceuticals BV, TheNetherlandsMr JosepLluis Caparros, DSMMr Matt Moran, Pharma Chemical IrelandDr Chris Oldenhof, DSM AntiInfectives, The NetherlandsDr Boris Pimentel, DNP (DSM Nutritional Products),SwitzerlandDr Stephan Rosenberger, Siegfried AG, SwitzerlandMr Oliver Schmidt, Concept Heidelberg, GermanyMr Anthony Storey, Pfizer, UK
About CONCEPT HEIDELBERGFounded in 1978, CONCEPT HEIDELBERG is the leadingorganiser of seminars on pharmaceutical production,quality control, quality assurance and GMP in Germany,Austria and Switzerland. This year more than 240 eventswill be organised by CONCEPT HEIDELBERG.
DateRegistrationSunday, 8 October 2006, 19.00 20.00 h orMonday, 9 October 2006, 09.00 h 10.00 hRegulatory Affairs Part:Tuesday, 10 October 2006, 08.0008.30 h
ConferenceMonday, 9 October 2006, 10.00 h – 17.30 hTuesday, 10 October 2006, 08.30 h – 18.00 hWednesday, 11 October 2006, 09.00 h 14.00 h
VenueHotel Intercontinental PrahaNamesti Curieovych 435Prague, 110 00Czech RepublicPhone (Hotel Front Desk) +420 29 66 31 111Fax +420 29 66 31 216
FeesBook the GMP Part (910 October) or the Regulatory Affairs Part(1112 October) separately for the price of € 1,590.00 each.Or book all three conference days for the special price of € 1,890.00.The registration fee is payable in advance after receipt of invoice.
DiscountsAPIC Members 10%, Inspectorates 25%.
Earlybird Discount!If you register for this event until 30 March, you receive a 5% earlybird discount on the registration fee. Dicounts cannot be combined!
AccommodationCONCEPT has reserved a limited number of rooms in theIntercontinental Praha Hotel. Reservation should be made directlywith the hotel not later than 25 September. Be sure to mentionCONCEPT to receive the specially negotiated rate for the duration ofyour stay. Early reservation is recommended.
RegistrationVia the attached reservation form, by email or by fax message. Oryou register online at www.apiconference.org
Conference languageThe official conference language will be English.
OrganisationCONCEPT HEIDELBERGP.O. Box 10 17 64, 69007 Heidelberg, GERMANYPhone +49 (0) 62 21/84 440, Fax +49 (0) 62 21/84 44 34Email: info@conceptheidelberg.dewww.conceptheidelberg.de
Dr Barbara Jentges (phone + 49 (0) 62 21 / +84 44 0, email:jentges@conceptheidelberg.de) the responsible project manager,will help you with any questions as regards content. Mrs MarionGrimm (phone + 49 (0)62 21 / 84 44 18, email: grimm@conceptheidelberg.de), the responsible organisation manager, will help youwith any questions concerning reservation, hotel, etc.
If the billtoaddress deviates from the specificationto the right, please fill out here::
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CONCEPT HEIDELBERGP.O. Box 10 17 64Fax +49 6221 / 84 44 3469007 HeidelbergGERMANY
Registration Form (Please complete in full)
9h APIC/CEFIC European Conference on Active Pharmaceutical Ingredients9 11 October 2006, Prague, Czech Republic
I want to take part in£ GMP Part (9 10 October 2006)£ Regulatory Affairs Part (10 11 October 2006)£ All three conference days (9 11 October 2006)Choose 2 out of 8 parallel sessions (one choice in Session I and one in Session II)First choice Second choice (in case your first choice is fully booked) Parallel Session I£ £ Session 1: APIC Guide on Quality Management£ £ Session 2: Riskbased Approach for Equipment Qualification£ £ Session 3: Critical Quality Attributes in a Multi Customer Environment£ £ S ession 4: How to establish a 6 Sigma Concept in an API Plant Parallel Session II£ £ Session 5: A new API Powder Processing Facility Regulatory Aspects£ £ Session 6: How to define the API Starting Material – Case Studies£ £ Session 7: API Dossier Requirements in Japan£ £ Session 8: Biotech Topic
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