QbD for Generics ISPE 2012 CONFERENCE SERIES. Building a Successful Business Case Through Practical Case Studies June 2012

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1 ISPE 2012 CONFERENCE SERIES QbD for Generics Building a Successful Business Case Through Practical Case Studies June 2012 Thon Hotel Brussels City Centre Brussels, Belgium Jointly organised with EGA

2 CONFERENCE OVERVIEW The programme will include keynote speeches from the CHMP/CVMP Quality Working Party as well as experts from regulatory authorities and the generic medicines industry. The US FDA Office of Generic Drugs will attend and share their views. The Workshops will take the form of interactive sessions between participants. There will be at least two leaders for each Workshop. Each participant will receive case study or background material in advance of the conference. The leaders will give a brief introduction to the topic, case study and tasks, and facilitate discussion amongst participants using questions given on the agenda. The goal is for participants to produce their own suggestions of answers. Workshop leaders will collate responses from each Workshop and present feedback to the plenary group. Participants will have the opportunity to attend two out of the three Workshops since the Workshop sessions will be held twice. For full agenda visit SPONSORSHIP AND EXHIBITION Event Sponsorships Provide Valuable Exposure ISPE hosts several high-profile events each calendar year, providing you with multiple opportunities to gain excellent exposure for your company. Choose from a variety of sponsorship packages to enjoy value-added benefits that will give you an edge on your competition. Build brand awareness and engage with decision-makers and buyers of production-related equipment and services as an ISPE Event Sponsor or Exhibitor. Introduce your products and services to an audience actively seeking solutions to GMP challenges. ISPE Conferences attendees include senior level executives and management from top pharmaceutical companies, around the world in search of solutions that will help them lower production costs, improve process efficiencies, increase production quality and meet regulatory compliance. Two Days Table Top Package (+ VAT) Access to two Coffee Breaks, two Standing Lunches and a Networking Reception in the Exhibition Hall Your company description and information in the Delegates Welcome Pack One-day Exhibition Guest Pass 15% discount for Table Top Personnel to attend a Seminar session One banquet table (180cm x 80cm) to display your literature, products and services Onsite, personnel assistance from ISPE exhibition staff Two Days Table Top Package plus Technology Session (+VAT) This includes: Take your brand centre stage with a 30 commercial presentation Presentation advertised in all event marketing communication Invitation in the Delegates Welcome Pack Premium Table Top (+VAT) This includes: All items listed for Table Top Package Priority choice of Table Top allocation (subject to availability) Enhanced listing in Exhibitor Directory featuring: Company logo 30-word company description

3 ConferenCe AgendA Wednesday, 27 June Keynote Presentations: Demystifying Quality by Design from an EU Regulator s Perspective Jean-Louis robert, ema US Regulatory Perspective on the Implementation of QbD for Generic Drugs Keith webber, fda Implementation of ICH Q9 and Q10 in the EU Jacques Morenas, AnSM (formerly Afssaps) Networking Break Keynote Presentations: The Quality by Design Paradigm and the Generics Industry Pito roslansky, Sandoz International gmbh Case Study One: QbD in Generic Drug Development françois A. Menard, watson Case Study Two: QbD Applied to API Spray Drying José Ascensão, Hovione Case Study Three: QbD Applied to API Chemical Process Development Jan ramza, Polpharma Introduction to Breakout Groups Session Adjourns Exhibition Networking Reception

4 Thursday, 28 June Workshop A: Why Consider QbD? Workshop B: How do you Effectively Develop Products and Processes Using QbD? Workshop C: What are the Regulatory Expectations Associated with a QbD Submission and How to Integrate them into Real-Life? Networking Break Repeat of Workshops A, B & C for Second Attendance Lunch Feedback from Workshop A Feedback from Workshop B Feedback from Workshop C Panel Discussion: Impediments and Incentives - Using the Workshop Feedback to Identify What are the Next Steps Workshop Closes

5 ISPE 2012 CONFERENCE SERIES This event will be the first in Europe to focus on the practical applications of the concept of Quality by Design (QbD) to the pharmaceutical development and manufacturing of generic medicines. The PQLI Practice Guide and the NEW ISPE PQLI Guides from Concept to Continual Improvement (Part 1 and 2) will be integrated into the content of the various workshop sessions and complimentary electronic copies of both publications will be given to registrants. It will offer a unique discussion platform for the generic medicines industry and regulators to gain essential updates and clarification on technical and business elements of QbD, as well as QbD s regulatory implications. ISPE PINNACLE PROGRAMME 2012 Global Sponsor Sponsorship Opportunities Available Sponsoring an ISPE educational seminar or training programme is a cost-effective way to gain competitive advantage, increase name recognition, and create top-of-mind awareness in today s pharmaceutical science and biotechnology manufacturing industry. Sponsorships include pre-event exposure on the ISPE website as well as the delegate mailing list, onsite exposure with exhibit opportunities, company logo on signage, and mentions in print and electronic communication. For more information or to secure your sponsorships, contact Murat Dogru at murat.dogru@associationhq.com

6 REGISTRATION FORM Please return to: ISPE Registration Services Avenue de Tervueren, 300 B-1150 Brussels, Belgium Tel: Fax: europeregistrations@ispe.org SAVE TIME REGISTER ONLINE: I. Delegate Information Prefix: First Name: Last Name: Job Title: Company: Address: City: Postal Code: Country: Telephone: Fax: Company VAT number (mandatory): Mobile: q I wish to keep my data confidential (only for use by ISPE and its local Affiliates and Chapters) q I do not wish for my details to be printed in ISPE s Membership Directory or on Conference Attendance Listings II. Conference Registration Prices below do not include VAT 21% Belgian VAT is applicable on registration fees only. Are you an ISPE Member? q Yes, membership number: q No If you wish to become a Member of ISPE and benefit from lower registration fees, please select New Member registration fees. 210 (VAT exempt) for your one-year membership is included in the New Member fees indicated below. If you do not wish to become a Member of ISPE, please select the Nonmember fees. q Tick here if you are a first time attendee REGISTRATION FEES (discounts cannot be combined) QBD FOR GENERICS Building a Successful Business Case Through Practical Case Studies Wednesday 30 May Friday 1 June, 2012 ON OR BEFORE 1 June 2012 AFTER 1 June 2012 q EGA Members q ISPE Members q ISPE New Members q Non EGA Members q Non ISPE Members q EGA Board & Committees q ISPE Board & Committees q Academic - NGO - Government III. Method of Payment (21% Belgian VAT should be included in the total payment, Conference Fees excluding 210 membership fee on New Member registrations) 21% VAT Total Due: q Credit Card q AMEX q Visa q Mastercard Credit Card Number: Expiry Date: / Cardholder s Name: Signature: IV. Special Needs (dietary or other): V. Hotel Information Thon Hotel Brussels City Centre Avenue du Boulevard 17 B-1210 Brussels, Belgium Main Phone: Reservations: Room rates: Single room: 155 (Breakfast included) Double room: 175 (Breakfast included) (Rates include 6% VAT, service charge and buffet breakfast and exclude city taxes of 6.40/room/night) ISPE has secured a number of bedrooms at a fixed group rate for your convenience. All accommodation bookings must be made directly with the hotel and are subject to availability. To benefit from the ISPE group rate, reservations must be received before 15 May 2012 and the official booking form must be used. The Booking Form is available online at The completed form must be returned directly to the Thon Hotel Brussels City Centre by to reservations@thonhotels.be or by fax to VI. Signature By signing I agree with the ISPE Registration and Cancellation Policies (see Date: Signature:

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