Workshop “Harmonizing Clinical Trial GMP and Quality Requirements across the EU and beyond”Creating a shared vision for industry and regulators

March 2 - 4, 2005Hotels van Oranje, Noordwijk aan Zee, and Amsterdam (social event)the Netherlands

CALL FOR QUESTIONS / PROGRAMME / REGISTRATION

Organised by the Industrial Pharmacy Section and the Special Interest Group Quality of the International Pharmaceutical Federation (FIP)

in co-operation with the International Association for Pharmaceutical Technology (APV) and the Netherlands Association for Industrial Pharmacists (NIA)

www.qualityworkshop.nl

INTRODUCTION

WHY YOU SHOULD REGISTER! This Workshop will serve as a perfect platform to share experiences with the new EU process for clinical trials. The December 2004 draft CHMP Guideline on the requirements to the quality part of a request for authorisation of a clinical trial will be presented and discussed extensively in one of the Break-Out sessions. The GMP Annex 13 and its implications will be discussed in detail in the second Break-Out session. In a third Break-Out session we will discuss specification development. Participation of both industry representatives and regulators in break-out sessions will provide an opportunity for in-depth analysis of the problems perceived from both sides. A compilation of the relevant comments will be submitted to EMEA as part of the public consultation process.

HARMONIZING CLINICAL TRIAL QUALITY REQUIREMENTS ACROSS THE EU!In April 2004, EMEA published a paper that discussed the quality part of a request for authorisation of a clinical trial. The paper clearly pointed out the differences between the CMC requirements to a request for authorisa-tion of a clinical trial and those for a marketing authorisation application. Currently a harmonised guideline on the quality part is under development. Harmonised requirements should increase transparency and predictability and should facilitate sponsors to perform multi-centre studies in the EU.

The guideline not only harmonises the requirements presently established in the individual EU member states, but moreover also specifies the require-ments for investigational medicinal products to be tested in clinical phases I, II and III. The draft guideline is planned to be released for 6 months consul-tation in December 2004.

UNDERSTANDING GMP REQUIREMENTS AND THE ROLE OF THE QUALIFIED PERSON!In May 2004 the Annex 13 to the GMP guideline came into force. The Product Specification File was introduced as well as a Qualified Person dedicated for Investigational Medicinal Products. It required pharmaceutical industry to reconsider the documentation and the flow around the clinical trial medication and its manufacturing. The new GMP guideline also raised a substantial amount of inspection issues.

SUBMIT YOUR QUESTIONS TODAY ! Questions concerning IMPDs, Product Specification Files, GMP and inspec-tions for investigational medication production, and specification setting during development can be posted upfront through www.qualityworkshop.nl

AMSTERDAMFinally we offer you a sparkling night with a wonderful dinner in Amsterdam. Enjoy the canals, the bridges, and the fantastic atmosphere. We kindly invite you to register for this quality workshop, to share experiences with colleagues, to participate in the break-out sessions and to discuss the new EU guideline directly with the decision-makers. This is your unique opportunity to influence the decision-making process!

The Organizing Committee,• Tom Sam, President Industrial Pharmacy Section, FIP (chair)• Susanne Keitel, Federal Institute for Drugs and Medical Devices (BfArM) (co-chair)• Charles Crevoisier, Vice-president APV• Mathijs Steegstra, NIA• Annemarie Möritz, EFPIA• Menno van der Waart, EUFEPS

Advisory Committee:Vinod Shah, FDABorislav Borissov, Bulgarian Drug AgencyAjaz Hussain, FDAAtilla Hinçal, Hacettepe University Henk de Jong, IPECEmer Cooke, EMAMary M. Lyda, KMI ConsultingKen Leiper, RPSGBLembit Rägo, WHO Joyce Ramsbotham, EFPIAAnna-Maria Tivert, EUFEPSTony Cartwright

LanguageThe language of the workshop is English.

09.15 Welcome and Introduction Dr Tom Sam, Organizing Committee

09.30 KEYNOTE PRESENTATION The newly established EU system on clinical trials - does it address the need for European harmonisation? Dr Birka Lehmann, Pharmaceuticals, Regulatory Frameworks and Market Authorisation Unit, Directorate-General Enterprise, European Commission

SESSION 1THE CLINICAL TRIAL APPLICATION PROCESS - EU/USA Chairperson: Dr Birka Lehmann 10.00 Is the European Clinical Trial Directive flexible enough to accommodate industry’s needs? Dr Yves Juillet, Senior Advisor, Les Entreprises du Médicament (LEEM), France (ICH Global Cooperation Group Co-Chair)

10.30 The US IND system Dr David Lin, FDA (invited)

11.00 Coffee

WEDNESDAY MARCH 2, 2005

SESSION 2EXPERIENCES WITH IMPD SUBMISSIONSChairperson: Dr Susanne Keitel, BfArM 11.20 UK Competent Authorities Dr Elaine Godfrey, MHRA

11.50 Problems encountered in the pre-harmonized IMPD Drs Jan-Jaap Scherpbier, Director Regulatory Affairs, Organon

12.20 IMPDs for biotech products Dr Valerie Colin, Senior Regulatory Affairs Officer, Quintiles

12.50 Innovative/global industry Dr Rodney Horder, Vice President of R&D Quality Assurance, Abbott, USA

Group Photo

13.15 Lunch

SESSION 3GOOD MANUFACTURING PRACTICES FOR INVESTIGATIONAL MEDICINAL PRODUCTSChairperson: Dr Annemarie Möritz, Novartis

14:30 Differences between Investigational Medicinal Products compared to Marketed Products - Industry view Dr Andy Tudor, Pfizer

15.00 The missed chance of harmonisation and streamlining - an industry view demonstrated on the example of the labelling issue Dr Rango Dietrich, Altana

15.30 Production of investigational medicinal products under GMP Prof Erik Frijlink, Solvay/RUG

16.00 Experiences with implementation of Annex 13: the Product Specification File - Inspector’s point of view Dr Giampiero Lorenti, Italy (invited)

16.30 Tea

SESSION 4THE CLINICAL TRIAL APPLICATION PROCESS - TOWARDS A HARMONIZED QUALITY DOCUMENT Chairperson: Dr Jean-Claude Arnold, Sanofi-Aventis

17.00 The new harmonized EU IMPD guideline Dr Susanne Keitel, BfArM

17.30 US-requirements - a regulator’s point of view Dr David Lin, FDA, CDER (invited)

Objectives and logistics for day 2

20.00 Dinner

Chairperson: Dr Susanne Keitel

08:30 Viewpoint of the generic industry Dr Karin Klokker, Hexal

09.00 BREAKOUT SESSIONS The three breakout sessions each last 90 minutes (15 minute introduction by moderators, 60-65 minutes discussion followed by a 5-10 minute summary).

Session A: New EU guidance on the IMPD quality dossier - discussion of critical points

Moderators: Dr Susanne Keitel, BfArm Dr Mike James, GlaxoSmithKline

Session B: Setting specs during development

Dr Chi-Wan Chen, FDA (invited) Dr Volker Eck, Nerviano Medical Science

Session C: Implementing Annex 13 to the GMP guideline

Moderators: Dr Eric Ligtenberg, QP Solvay Drs Hans Smallenbroek, Dutch Inspectorate, PIC/S

Sessions will be repeated throughout the day:

09.30 - 11.00 Session 11.00 Coffee11.30 - 13.00 Session 13.00 Lunch14.30 - 16.00 Session

There will be a splendid evening programme in Amsterdam; buses leave at 16.00 h. For more details of the programme see “Social Programme”.

THURSDAY MARCH 3, 2005

FRIDAY MARCH 4, 2005SESSION 5 Clinical Trial Applications outside the ICH regionsChair: Dr Charles Crevoisier

09:00 Experiences with a harmonized IMPD/IND quality document around the globe (Brazil, Chili, Filippines, India, Malaysia, Russia, Rumenia, South-Korea, Turkey, etc.) Dr Cheenu Murti, Organon

09:30 Experiences with clinical trial applications in developing countries Dr Lembit Rägo, Quality Assurance and Safety of Medicines Essential Drugs and Medicines Policy, WHO

10:00 Coffee

REPORTS FROM THE BREAK-OUT SESSION

10:30 Report from Session A: New EU guidance on the IMPD quality dossier Moderators: Dr Susanne Keitel, BfArM Dr Mike James, GlaxoSmithKline

11:10 Report from Session B: Setting specs during development Dr Chi-Wan Chen, FDA (invited) Dr Volker Eck, Nerviano Medical Science Report from Session C: Implementing Annex 13 to the GMP guideline Moderators: Dr Eric Ligtenberg, QP Solvay Drs Hans Smallenbroek, Dutch Inspectorate, PIC/S

Summary and Conclusions: Towards Harmonization12:00 Dr Tom Sam / Dr Susanne Keitel12:30 Closure12:45 Farewell Lunch

before February 1, 2005 starting February 1, 2005

Fee Eur 995,00 Eur 1195,00

Please note that the fee is excluding 6% VAT

FEES

HOTEL

LocationThe Workshop will take place in the Hotels van Oranje. The Hotels van Oranje are situated directly on the splendid promenade and the wide sandy beaches of Noordwijk aan Zee. Grandeur of days gone combined with the luxurious facilities of present-day comfort form the ideal basis for delightful relaxation in the most fashionable seaside resort in the Netherlands.

Hotels van Oranje, Koningin Wilhelminaboulevard 20-312202 GV, Noordwijk aan ZeeThe NetherlandsTel +31 - (0)71 367 6869Fax +31 - (0)71 367 6800E-mail: info@hotelsvanoranje.nl

Hotel ReservationA number of rooms has been reserved at specially reduced rates. For hotelpackages and rates, see following page. Complete the reservation form and send it to ATP Congresses & Meetings as soon as possible.

3-days package March 2-4, two nights of March 2 & 3, 2005

HO1-HOTEL ORANJEPackage incl. room for single use for 2 nights in Hotel Oranje, 1 dinner on 2nd of March 2005. à EUR 440,00

HO2-HOTEL ORANJEPackage incl. room for double use for 2 nights in Hotel Oranje, 1 dinner on 2nd of March 2005. à EUR 308,00

BE1-BEACH HOTELPackage incl. room for single use for 2 nights in the Beach Hotel, 1 dinner on 2nd of March 2005. à EUR 365,75

BE2-BEACH HOTELPackage incl. room for double use for 2 nights in the Beach Hotel, 1 dinner on 2nd of March 2005. à EUR 255,75

3-days package March 2-4, three nights of March 1 & 2 & 3, 2005

VHO1-HOTEL ORANJEPackage incl. room for single use for 3 nights in Hotel Oranje, 2 dinners on 1st and 2nd of March 2005. à EUR 657,25

VHO2-HOTEL ORANJEPackage incl. room for double use for 3 nights in Hotel Oranje, 2 dinners on 1st and 2nd of March 2005. à EUR 462,00

VBE1-BEACH HOTELPackage incl. room for single use for 3 nights in the Beach Hotel, 2 dinners on 1st and 2nd of March 2005. à EUR 528,00

VBE2-BEACH HOTELPackage incl. room for double use for 3 nights in the Beach Hotel, 2 dinners on 1st and 2nd of March 2005. à EUR 393,25

* All mentioned packages and rates are PER PERSON excluding city tax

HOTEL PACKAGES

INDUSTRIALPHARMACY

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ORGANISERS

IPS / FIPFIP’s Industrial Pharmacy Section unites all industrial pharmacists world-wide including those active in marketing, regulatory, management, research, development, production, pharmacovigilance, and health economics.

IPS / FIP activities for your 2005 agenda• Workshop “GMPs for the 21st Century”, Cairo, sept 2-3• Symposia “Access to Medicines”; “The Price of Medicines”; “Selection, Supply and Distribution of Medicines”; “The World Wide Problem of Counterfeit Medicines”, FIP congress, sept 4 - 8 (www.fip.org)• Symposium “Dissolution testing – A pivotal tool for development and quality control of drugs”, Cairo, FIP Congress, sept 7• Symposium “Good Chemistry, Manufacturing and Controls Practice”, Cairo FIP Congress, sept 8• Symposium “Development of Pharmaceutical Industry in Africa and the Middle East”, Cairo FIP Congress, sept 8• Quality International conference “Managing quality throughout the product life cycle” together with RPSGB, London, November 21-22

More information will be available at www.ips50years.org or contact our IPS secretariat at: henriette.jansen@organon.com

Becoming IPS / FIP member Use the FIP website procedure (1. membership apply at www.fip.org and indicate 2. Industrial Pharmacy as your complimentary section). In addition to your FIP-membership, you will benefit from a free subscrip-tion worth € 75 to “Industrial Pharmacy”, the quarterly magazine publis-hed by Euromed for pharmaceutical scientists and executives (for a typical example see www.industrialpharmacy.com). Also join IPS in celebrating its 50th anniversary in Cairo and London (www.ips50years.org)

APVThe APV (International Association for Pharmaceutical Technology) is an association for pharmaceutical scientists, with headquarters located in Mainz, Germany. Every year the APV conducts about 100 programmes of various types, ranging from international conferences through expert meetings and workshops for practising pharmaceutical scientists and pharmacists to bota-nical expeditions (for an overview see www.apv-mainz.de).

NIAThe NIA (www.nia-web.nl) is the Dutch Association of Industrial Pharmacists. Its goal is to further the interests of the Dutch Industrial Pharmacists and as such to enhance all aspects of industrial pharmacy in The Netherlands. The NIA has about 500 members and one of the major activi-ties is to organise business events including opportunities for networking. Next to that the NIA strives to maintain and/or improve the quality of the pharmaceutical education in order to ensure the future quality of industrial pharmacists.

ATPThis Quality Workshop is organised for FIP by ATP Congresses & Meetings, a Professional Congress Organiser (www.atp.nl).

Press contact and Public RelationsDidier Mouliom, 1QOL-DNM, 9 Villa Pierre Ginier, 75018 Paris-France, tel: + 33 1 53 04 23 47, fax : + 33 1 53 04 23 64, mobile : + 33 6 19 85 55 12, Email: didier.mouliom@ips50years.org

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Preferably register online (www.qualityworkshop.nl) or send the registration form to:

Congress Bureau Tel: +31 70 376 6733 ATP CONGRESSES & MEETINGS Fax: +31 70 427 2770 PO Box 11632 2502 AP The Hague E-mail: fip@atp.nl The Netherlands

Please provide information as you wish it to appear on your badge and in the list of participants. One copy of this registration form should be completed for each active participant. Please complete in block letters. Do not forget to take a copy for your own records.

Payment Payment must be made in Euro. Please state your name and address clearly on money orders.

Booking and cancellation conditions of registration and special dinner 1. Registration can only be made through this registration form.2. Hotel registration will be handled by Hotels van Oranje3. Cancellation conditions: * Cancellation and/or changes should be made in writing to ATP Congresses & Meetings. * Cancellation charges: - in case of a cancellation before January 15, 2005: 25% of the total reservation value will be charged. - in case of a cancellation from January 15 until February 1, 2005: 50% of the total reservation value will be charged. - in case of a cancellation from February 1 until March 4, 2005 and/or in case of a no show: 100% of the total reservation value will be charged. Substitutions can be made at any time. 3a. In case a credit card guarantee has been given, the credit card will be charged by ATP Congresses & Meetings accordingly. 3b. In case the reservation value has been paid by bank, the cancellation charges will be settled after the congress.4. We do not accept cheques for payment.5. Any refunds will be processed after the congress.6. On all bank payments we will add Euro 25,00 bankcosts7. On all credit card charges we will add 5% costs of the total amount.8. The costs for the congres registration excludes 6% VAT.

Booking and cancellation conditions of Hotel1. Cancellation conditions: * Cancellation and/or changes should be made in writing to Hotels van Oranje * Cancellation chages: - in case of a cancellation before January 15, 2005: 25% of the total reservation value will be charged. - in case of a cancellation from January 15 until February 1, 2005: 50% of the total reservation value will be charged. - in case of a cancellation from February 1 until March 4, 2005 and/or in case of a no show: 100% of the total reservation value will be charged. Substitutions can be made at any time.

1a. In case a credit card guarantee has been given, the credit card will be charged by Hotels van Oranje. 1b. In case the reservation value has been paid by bank, the cancellation charges will be settled after the congress.2. Any refunds will be processed after the congress.3. The registration fee for the hotel is € 3 per reservation.

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Amsterdam Adventure Tour with Special dinner on Thursday March 3rd, 2005I want to join the special dinner with person(s).Costs of the Amsterdam Adventure tour including transport, dinner and drinks are €140,00 per person (excl. tax). You are advised to pay upfront, since the capacity of the venue is limited. The costs will be added to your conference fee.

Registration fees Fee before February 1st, 2005 ❑ € 995,00 Fee starting February 1st, 2005 ❑€ 1195,00

You will be able to attend at least two of the three Break-out sessions. Please indicate which two sessions have your preference.

Preference 1 ❑ Session A ❑ Session B ❑ Session CPreference 2 ❑ Session A ❑ Session B ❑ Session C

❑I prefer to pay my conference fee by credit card Underneath you will find my credit card details (amount incl.credit card costs will be charged) Type of Card: ❑Amex ❑Visa ❑Euro/Mastercard ❑Diners Card Number

Expiration date (mm/yy)

CVC code* (*CVC Code: The final 3 digits on back of the credit card. Please note that with Amex the CVC Code are the final 4 digits on the front of the card)

Card holder’s name

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Signature card holder (essential)

❑I prefer to pay my conference fee by bank I will receive an invoice which has to be paid within two weeks. Hotel❑HO1 ❑VHO1 ❑HO2 ❑VHO2 ❑BE1 ❑VBE1 ❑BE2 ❑VBE2 ❑NO HOTEL Share with:

I herewith declare that I have read and agreed with all booking and cancellation conditions as stated in the previous page.

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SOCIAL PROGRAMME

1. WELCOME RECEPTION ON TUESDAY MARCH 2, 2005 (19:00 - 20:00 h) All our guests are welcomed with a free drink in the Bentley bar with a marvellous view over the Northsea.

2. LUNCHES The Workshop has been designed to optimise interactions between participants. Lunches will be used together during all three days.

3. AMSTERDAM ADVENTURE TOUR WITH SPECIAL DINNER ON THURSDAY MARCH 3, 2005 (16.00 - 23.00 h)The organizing committee invites you to join the special dinner, which will be held at the famous ‘West Indies House’ in the heart of Amsterdam ‘s characteristic centre. The rich history of this building starts in 1617 and forms a truly unique setting for this special event. All participants will be taken by bus from the Hotels van Oranje to Amsterdam. There the Dutch Adventure begins. We will start with a walking tour through the darkest alleys to the oldest buildings in town. Your guide will be a 17th century city soldier armed with a halberd. These soldiers used to guard the city as immortalised in Rembrandts ‘Nightwatch’. The tour is a mixture of past and present. You will disco-ver a monastry and one of the last wooden houses and will be guided to the Jordaan quarter, famous for its courtyards and ‘popular’ singers.The walking tour ends at the West Indies House. Until 1623 the ground-floor was used as a meat-market, with rooms above for De Schutterij, the city militia that had to watch over the safety of Amsterdam.

The House owes its name to the period between 1623 and 1647, when the Lords of Nineteen wielded the sceptre over the Dutch West-India Trading Company (West-Indische Compagnie) from here. The historic West Indies House is entered via a picturesque courtyard which is surrounded by four elegant and spacious rooms. The magnificent setting combines stylish accommodation with a unique historic atmosp-here. In the Compagnies room the decision was made to build the fort Nieuw Amsterdam on the island of Manhattan. In this particular room, a wonderful dinner will be served. After this special dinner the bus will bring you back to the hotel. Of course there is always the opportunity to “dive” into the nightlife of Amsterdam.

REGISTER NOW!!!