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, McKiernan Ass., Switzerland Gerald Migliaccio, Pfizer, USA Jan Moors, Teva / PCH Pharmachemie, The Netherlands Pieter Rouwette, Solvay Pharmaceuticals, Belgium Jan Smeets, DSM Anti-Infectives, The Netherlands Marten Wiersma, NV Organon, The Netherlands
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9th APIC/CEFIC European Conference on
Active Pharmaceutical 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
This year, the 9th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients will take place in Prague / Czech Republic. “ Maybe there has never been a better moment in time for an API Conference than October 2005!” is what we wrote in our last year’s conference brochure. The liveliness and outcome of the Berlin event and the extensive publicity it received thereafter fully confirmed that this was not an overstatement. But regulatory reality does not change overnight. If you want to be updated fully, then attending the 9 th APIC/CEFIC Conference on APIs is a must. Moreover, we have carefully selected top speakers who are active as decision makers within the complex, ongoing process of regulatory change. A special feature of the joint day will be 8 parallel sessions on GMP and Regulatory Affairs. Participants have the opportunity to choose between different topics. The conference will allow enough time for networking with other colleagues to exchange information about best practices among industry representatives. You will also be able to get into contact with high ranking officials from EU, FDA and inspectors.
GMP Conference
Objective In the EU the new API legislation on GMP and its supporting guidelines and systems are in the process of transformation from being written words only to becoming reality. Audits, inspections, certifications … where will we stand in October 2006? And how do the new requirements impact on a major API producing country such as e.g. India? Meanwhile the developments on regulatory reform are continuing in the USA. But during the past year it has become clear that these developments are getting more and more a global character with e.g. the EU having dropped its initially hesitant attitude towards ICH Q10. So ICH is reinforcing its key role in International Harmonization, now also in the arena of Regulatory Reform. By attending the GMP Conference you will get an update on the latest development from the decision makers in Europe and US. One Year after Implementation of the New EU API Legislation: An Update from EMEA One Year after Implementation of the New EU API Legislation: An Industry View on and Experiences With the Current System and Procedures for API Inspections and -Auditing Jan Moors cGMP Lifecycle Approach for Validation in the 21st Century How to Implement ICH Q9 into an API Plant Barbara Lani ICH Q10 – Status Quo
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Social Event on 9 October
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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 Day
Parallel Sessions I
Session 1: APIC Guide on Quality Management Session 2: Risk-based Approach for Equipment Qualification Pieter Rouwette Session 3: Critical Quality Attributes in a Multi Customer Environment Henri Leblanc Session 4: How to establish a 6 Sigma Concept in an API Plant Jim McKiernan Parallel Sessions 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 Marieke van Dalen Session 8: Biotech Topic
Regulatory Affairs Conference
Objective For API manufacturers, Regulatory Affairs (RA) is often still a problem area. This situation has not improved in the past years and has even become more difficult. The RA topics of the conference will include problems with and possible solutions for the post-approval authorisation of changes / improvements in API manufacture. Of course, ICH Q8, Q9 & Q10 as well as RA aspects of FDA’s 21st Century Initiative are items on the program. The running and new activities of the EMEA Quality Working Party will be highlighted and an update on new developments regarding the CEP procedure will be presented. Also, options for the more transparent development of new regulations and guidance will be discussed.
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FDA’s Latest Quality Assessment Issues Moheb Nasr Impurities Jan Smeets New Developments regarding the CEP Procedure & the EDQM/OMCL Testing Programme for APIs on the European Market Revision of the Variations Regulations Mike J. James Closing Remarks Henri Leblanc
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ICH Q8 – What is Relevant for APIs John Berridge Quality by Design: An Industry View on How ICH Q8 Translates into Industrial API Practice and Increased Regulatory Flexibility Wendy Mavroudakis PAT Impact of European Legislation on Indian/Chinese API Manufacturers
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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
CEFIC, the European Chemical Industry Council, is the Brussels-based organisation representing national chemical federations and chemical companies of Europe. All in all, CEFIC represents, directly or indirectly, more than 29,000 large, medium and small chemical companies in Europe, which employ about 1.7 million people and account for nearly one third of world chemical production.
Date Registration Sunday, 8 October 2006, 19.00 - 20.00 h or Monday, 9 October 2006, 09.00 h - 10.00 h Regulatory Affairs Part: Tuesday, 10 October 2006, 08.00-08.30 h Conference Monday, 9 October 2006, 10.00 h – 17.30 h Tuesday, 10 October 2006, 08.30 h – 18.00 h Wednesday, 11 October 2006, 09.00 h - 14.00 h Venue Hotel Intercontinental Praha Namesti Curieovych 43-5 Prague, 110 00 Czech Republic Phone (Hotel Front Desk) +420 29 66 31 111 Fax +420 29 66 31 216
Speakers
Mr John Berridge, Pfizer, UK Dr Nandkumar Chodankar, Sekhsaria Chemicals Ltd., India Ms Marieke van Dalen, Diosynth B.V., The Netherlands 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
Chairmen
Mr Paul Michielsens, Solvay Pharmaceuticals, Belgium Mr Matt Moran, Pharma Chemical Ireland Dr Chris Oldenhof, DSM Anti-Infectives, The Netherlands
Fees Book the GMP Part (9-10 October) or the Regulatory Affairs Part (11-12 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. Discounts APIC Members 10%, Inspectorates 25%. Early-bird Discount! If you register for this event until 30 March, you receive a 5% earlybird discount on the registration fee. Dicounts cannot be combined! Accommodation CONCEPT has reserved a limited number of rooms in the Intercontinental Praha Hotel. Reservation should be made directly with the hotel not later than 25 September. Be sure to mention CONCEPT to receive the specially negotiated rate for the duration of your stay. Early reservation is recommended. Registration Via the attached reservation form, by e-mail or by fax message. Or you register online at www.api-conference.org Conference language The official conference language will be English. Organisation CONCEPT HEIDELBERG P.O. Box 10 17 64, 69007 Heidelberg, GERMANY 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 Dr Barbara Jentges (phone + 49 (0) 62 21 / +84 44 0, e-mail: jentges@concept-heidelberg.de) the responsible project manager, will help you with any questions as regards content. Mrs Marion Grimm (phone + 49 (0)62 21 / 84 44 18, e-mail: grimm@conceptheidelberg.de), the responsible organisation manager, will help you with any questions concerning reservation, hotel, etc.
Steering Committee
We would like to express our sincere gratitude to the members of the steering committee for developing the conference: Mr Pieter van der Hoeven, CEFIC, Belgium Dr Barbara Jentges, Concept Heidelberg, Germany Dr Henri Leblanc, Rhodia Organique, France Mr Paul Michielsens, Solvay Pharmaceuticals BV, The Netherlands Mr Josep-Lluis Caparros, DSM Mr Matt Moran, Pharma Chemical Ireland Dr Chris Oldenhof, DSM Anti-Infectives, The Netherlands Dr Boris Pimentel, DNP (DSM Nutritional Products), Switzerland Dr Stephan Rosenberger, Siegfried AG, Switzerland Mr Oliver Schmidt, Concept Heidelberg, Germany Mr Anthony Storey, Pfizer, UK
About CONCEPT HEIDELBERG
Founded in 1978, CONCEPT HEIDELBERG is the leading organiser of seminars on pharmaceutical production, quality control, quality assurance and GMP in Germany, 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 to the right, please fill out here::
9h APIC/CEFIC European Conference on Active Pharmaceutical Ingredients
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 Fax +49 - 6221 / 84 44 34 69007 Heidelberg GERMANY
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