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					                                              A Sector Group of




Authority Speakers
confirmed:
Moheb Nasr,
CDER, FDA, USA

Industry Speakers confirmed:
John Berridge,
Pfizer, UK
Dr Nandkumar Chodankar,
Sekhsaria Chemicals, India
Marieke van Dalen,
Diosynth, The Netherlands
Barbara Lani,
Bracco, Italy
Henri Leblanc,
Rhodia Chimie, France
Wendy Mavroudakis,
Johnson&Johnson, USA
Jim McKiernan,
                                                                                           if
                                                                                     count
McKiernan Ass., Switzerland
Gerald Migliaccio,
                                                                         rly-bird dis til
Pfizer, USA                                                       5 % ea register un
Jan Moors,                                                             y ou        2006
Teva / PCH Pharmachemie,
                                                                         30 March
The Netherlands
Pieter Rouwette,
Solvay Pharmaceuticals,        9th APIC/CEFIC European Conference on

                               Active
Belgium
Jan Smeets,
DSM Anti-Infectives,
The Netherlands




                               Pharmaceutical
Marten Wiersma,
NV Organon, The Netherlands




                               Ingredients
                               9-11 October 2006, Prague, Czech Republic


                                       GMP Conference
                                       9-10 October 2006


                                       Regulatory Affairs
                                       Conference
                                       10-11 October 2006
9th APIC/CEFIC European Conference on
Active Pharmaceutical Ingredients
Conference Programme                                        GMP Conference
                                                            Objective
This year, the 9th APIC/CEFIC European Conference
                                                            In the EU the new API legislation on GMP and its
on Active Pharmaceutical Ingredients will take place
                                                            supporting guidelines and systems are in the process
in Prague / Czech Republic.
                                                            of transformation from being written words only to
                                                            becoming reality. Audits, inspections, certifications
“ Maybe there has never been a better moment in time
                                                            … where will we stand in October 2006?
for an API Conference than October 2005!” is what we
wrote in our last year’s conference brochure.
                                                            And how do the new requirements impact on a
The liveliness and outcome of the Berlin event and
                                                            major API producing country such as e.g. India?
the extensive publicity it received thereafter fully
confirmed that this was not an overstatement.
                                                            Meanwhile the developments on regulatory reform
But regulatory reality does not change overnight.
                                                            are continuing in the USA. But during the past year it
                                                            has become clear that these developments are
If you want to be updated fully, then attending the 9 th
                                                            getting more and more a global character with e.g.
APIC/CEFIC Conference on APIs is a must.
                                                            the EU having dropped its initially hesitant attitude
Moreover, we have carefully selected top speakers
                                                            towards ICH Q10.
who are active as decision makers within the
complex, ongoing process of regulatory change.
                                                            So ICH is reinforcing its key role in International
                                                            Harmonization, now also in the arena of Regulatory
A special feature of the joint day will be 8 parallel
                                                            Reform. By attending the GMP Conference you will
sessions on GMP and Regulatory Affairs. Participants
                                                            get an update on the latest development from the
have the opportunity to choose between different
                                                            decision makers in Europe and US.
topics.

The conference will allow enough time for
                                                            n   One Year after Implementation of the New EU
networking with other colleagues to exchange
                                                                API Legislation: An Update from EMEA
information about best practices among industry
representatives. You will also be able to get into
                                                            n   One Year after Implementation of the New EU
contact with high ranking officials from EU, FDA and
                                                                API Legislation: An Industry View on and
inspectors.
                                                                Experiences With the Current System and
                                                                Procedures for API Inspections and -Auditing
                                                                Jan Moors

Social Event on 9 October                                   n   cGMP Lifecycle Approach for Validation in the
                                                                21st Century

                                                            n   How to Implement ICH Q9 into an API Plant
                                                                Barbara Lani

                                                            n   ICH Q10 – Status Quo




The social event has become a tradition and was well
appreciated during the past conferences (in Brussels,
Hamburg, Vienna, Barcelona, Budapest, Lisbon and Berlin).
We will continue this tradition in Prague and invite all
participants and speakers to an entertaining evening
outside the hotel followed by a dinner.
Joint GMP and                                            Regulatory Affairs
Regulatory Affairs Day                                   Conference
Parallel Sessions I                                      Objective
                                                         For API manufacturers, Regulatory Affairs (RA) is often
Session 1:                                               still a problem area. This situation has not improved in
APIC Guide on Quality Management                         the past years and has even become more difficult. The
                                                         RA topics of the conference will include problems with
Session 2:                                               and possible solutions for the post-approval
Risk-based Approach for Equipment Qualification          authorisation of changes / improvements in API
Pieter Rouwette                                          manufacture. Of course, ICH Q8, Q9 & Q10 as well as
                                                         RA aspects of FDA’s 21st Century Initiative are items on
Session 3:                                               the program. The running and new activities of the
Critical Quality Attributes in a Multi Customer          EMEA Quality Working Party will be highlighted and an
Environment                                              update on new developments regarding the CEP
Henri Leblanc                                            procedure will be presented. Also, options for the more
                                                         transparent development of new regulations and
Session 4:                                               guidance will be discussed.
How to establish a 6 Sigma Concept in an API Plant
Jim McKiernan                                            n   FDA’s Latest Quality Assessment Issues
                                                             Moheb Nasr
Parallel Sessions II
                                                         n   Impurities
Session 5:                                                   Jan Smeets
A new API Powder Processing Facility - Regulatory
Aspects                                                  n   New Developments regarding the CEP Procedure
                                                             & the EDQM/OMCL Testing Programme for APIs
Session 6:                                                   on the European Market
How to define the API Starting Material – Case Studies
                                                         n   Revision of the Variations Regulations
Session 7:                                                   Mike J. James
API Dossier Requirements in Japan
Marieke van Dalen                                        n   Closing Remarks
                                                             Henri Leblanc
Session 8:
Biotech Topic



n   ICH Q8 – What is Relevant for APIs
    John Berridge

n   Quality by Design: An Industry View on How ICH
    Q8 Translates into Industrial API Practice and
    Increased Regulatory Flexibility
    Wendy Mavroudakis

n   PAT

n   Impact of European Legislation on Indian/Chinese
    API Manufacturers
                                                         Conference Exhibition
                                                         Would you also like to present an exhibition stand?
                                                         And have your company listed in the conference
                                                         programme? Please contact Ms Marion Grimm,
                                                         phone + 49-62 21 / 84 44 18,
                                                         e-mail: grimm@concept-heidelberg.de
About CEFIC                                                  Date
                                                             Registration
CEFIC, the European Chemical Industry Council, is the        Sunday, 8 October 2006, 19.00 - 20.00 h or
Brussels-based organisation representing national            Monday, 9 October 2006, 09.00 h - 10.00 h
chemical federations and chemical companies of Europe.       Regulatory Affairs Part:
All in all, CEFIC represents, directly or indirectly, more   Tuesday, 10 October 2006, 08.00-08.30 h
than 29,000 large, medium and small chemical
                                                             Conference
companies in Europe, which employ about 1.7 million          Monday, 9 October 2006, 10.00 h – 17.30 h
people and account for nearly one third of world             Tuesday, 10 October 2006, 08.30 h – 18.00 h
chemical production.                                         Wednesday, 11 October 2006, 09.00 h - 14.00 h

                                                             Venue
Speakers                                                     Hotel Intercontinental Praha
                                                             Namesti Curieovych 43-5
                                                             Prague, 110 00
Mr John Berridge, Pfizer, UK                                 Czech Republic
Dr Nandkumar Chodankar, Sekhsaria Chemicals Ltd., India      Phone (Hotel Front Desk) +420 29 66 31 111
Ms Marieke van Dalen, Diosynth B.V., The Netherlands         Fax +420 29 66 31 216
Ms Barbara Lani, Bracco, Italy
Dr. Henri Leblanc, Rhodia Chimie, France
Mrs Wendy Mavroudakis, Johnson&Johnson, USA
Mr Jim McKiernan, McKiernan Ass., Switzerland
Dr. Gerald Migliaccio, Pfizer, US
Mr Jan Moors, Teva / PCH Pharmachemie, The Netherlands
Dr Moheb Nasr, CDER, FDA, USA
Mr Pieter Rouwette, Solvay Pharmaceuticals, Belgium
Dr. Jan Smeets, DSM Anti-Infectives, The Netherlands
Dr Marten Wiersma, NV Organon, The Netherlands

                                                             Fees
Chairmen                                                     Book the GMP Part (9-10 October) or the Regulatory Affairs Part
                                                             (11-12 October) separately for the price of € 1,590.00 each.
Mr Paul Michielsens, Solvay Pharmaceuticals, Belgium         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.
Mr Matt Moran, Pharma Chemical Ireland
Dr Chris Oldenhof, DSM Anti-Infectives, The Netherlands      Discounts
                                                             APIC Members 10%, Inspectorates 25%.

                                                             Early-bird Discount!
Steering Committee                                           If you register for this event until 30 March, you receive a 5% early-
                                                             bird discount on the registration fee. Dicounts cannot be combined!
We would like to express our sincere gratitude to the
members of the steering committee for developing the         Accommodation
conference:                                                  CONCEPT has reserved a limited number of rooms in the
                                                             Intercontinental Praha Hotel. Reservation should be made directly
Mr Pieter van der Hoeven, CEFIC, Belgium
                                                             with the hotel not later than 25 September. Be sure to mention
Dr Barbara Jentges, Concept Heidelberg, Germany              CONCEPT to receive the specially negotiated rate for the duration of
Dr Henri Leblanc, Rhodia Organique, France                   your stay. Early reservation is recommended.
Mr Paul Michielsens, Solvay Pharmaceuticals BV, The
Netherlands                                                  Registration
Mr Josep-Lluis Caparros, DSM                                 Via the attached reservation form, by e-mail or by fax message. Or
                                                             you register online at www.api-conference.org
Mr Matt Moran, Pharma Chemical Ireland
Dr Chris Oldenhof, DSM Anti-Infectives, The Netherlands      Conference language
Dr Boris Pimentel, DNP (DSM Nutritional Products),           The official conference language will be English.
Switzerland
Dr Stephan Rosenberger, Siegfried AG, Switzerland            Organisation
                                                             CONCEPT HEIDELBERG
Mr Oliver Schmidt, Concept Heidelberg, Germany
                                                             P.O. Box 10 17 64, 69007 Heidelberg, GERMANY
Mr Anthony Storey, Pfizer, UK                                Phone +49 (0) 62 21/84 44-0, Fax +49 (0) 62 21/84 44 34
                                                             E-mail: info@concept-heidelberg.de
                                                             www.concept-heidelberg.de

About CONCEPT HEIDELBERG                                     Dr Barbara Jentges (phone + 49 (0) 62 21 / +84 44 0, e-mail:
                                                             jentges@concept-heidelberg.de) the responsible project manager,
Founded in 1978, CONCEPT HEIDELBERG is the leading           will help you with any questions as regards content. Mrs Marion
organiser of seminars on pharmaceutical production,          Grimm (phone + 49 (0)62 21 / 84 44 18, e-mail: grimm@concept-
quality control, quality assurance and GMP in Germany,       heidelberg.de), the responsible organisation manager, will help you
                                                             with any questions concerning reservation, hotel, etc.
Austria and Switzerland. This year more than 240 events
will be organised by CONCEPT HEIDELBERG.
                                                         Registration Form (Please complete in full)

If the bill-to-address deviates from the specification   9h APIC/CEFIC European Conference on Active Pharmaceutical Ingredients
to the right, please fill out here::                     9 - 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: Risk-based 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
            CONCEPT HEIDELBERG
            P.O. Box 10 17 64                               Mr                          Ms                         Title _______________________
            Fax +49 - 6221 / 84 44 34
            69007 Heidelberg                             ___________________________________________________________________________________________________
            GERMANY                                      First name, surname

                                                         ___________________________________________________________________________________________________
                                                         Company                                                   APIC Member     Inspectorate

                                                         ___________________________________________________________________________________________________
                                                         Department

                                                         ________________________________________________________________________________________
                                                         Important: Please indicate your company’s VAT ID Number

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                                                         Street / P.O. Box

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