Challenges in Global Product Development: Developing Rugged and Robust Products, Processes and Specifications
March 31st, April 1-2nd, 2009
Bar Ilan University
Tel Aviv, Israel
Bar Ilan University
Tel Aviv, Israel
Organized by Bar ilan University, KPA Ltd and Perrigo in collaboration with the Extension Services in Pharmacy, School of Pharmacy, University of Wisconsin-Madison
Brochure in Hebrew
Organized by Bar ilan University, KPA Ltd and Perrigo in collaboration with the Extension Services in Pharmacy, School of Pharmacy, University of Wisconsin-Madison
Registration
Your registration options are as follows:
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Register Online. Step 1. Login in using your user account. If you don't have a user account creating one is free & easy. Step 2. Click the appropriate links below to register for the program(s) you want to attend. Challenges in Global Product Development: Developing Rugged and Robust Products, Processes and Specifications
Please note: Proof of student/academia status will be required at conference check-in. If you do not have proof you will be billed/charged at the full rate. |
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Download the registration form, complete & mail to: Israel Conference Payment via credit card or check. |
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By phone at 608.262.3130 or toll-free at 877-947-4255. |
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Download the registration form, complete & fax to 608.262.2431. |
March 31st - April 2nd, 2009 Conference Target Audience
This conference is directed toward pharmaceutical scientists involved in industry and academia. Individuals attending will benefit from an outstanding and experienced faculty from many different areas of the phamaceutical arena. The mix of international and Israeli faculty has been brought together to give the participants a broad exposure to the concerns facing pharmacy. The faculty will address current practices as well as future opportunities in a worldwide market. Current regulatory concerns and an update on ICH vision on quality leading to new opportunities for forward looking companies and start-ups will be presented. Quality by Design (QbD) will be discussed to aid in the understanding and implementation of a systemic science and risk based approach to product realization. The approach to applying QbD to analytical methods will be described with implications of adopting this to the method transfer process. Throughout the conference the relationships between setting meaningful specifications and current and future regulatory expectations will be emphasized. Topics will be covered with a balance of theory and practical applications and there will be ample opportunities for the audience to participate in meaningful dialogue throughout the program.
Challenges in Global Product Development: Developing Rugged and Robust Products, Processes and Specifications Agenda
March 31st - April 2nd, 2009
Tuesday, March 31st |
8:30am-5:00pm |
| Check in and Registration |
| Opening Remarks: The QbD Challenge
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Session I | Quality Systems Based Thinking in a New Regulatory Environment
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| The ICH Quality Vision: Q8, Q9, Q10
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| Specifications Development, Maintenance and Supporting Stability Programs for Drug Products
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Session II | Quality by Design (QbD) and Its Clinical Relevance and Opportunities
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| Use of Design Of Experiments (DOE) for the Optimization of Nanomaterial Processing
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| Panel Discussion
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Wednesday, April 1 | 8:30am-5:00pm |
Session III | Risk Based CMC Decision Methodology in the Analytical & QC Lab
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| In Process Testing for the Manufacturing of Drug Products
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| QbD in Analytical Method Development
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Session IV | Transfer of Analytical Procedures
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| Minimizing Process-related Impurities in API synthesis: A Quality By Design Approach
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| Panel Discussion
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Thursday, April 2nd | 8:30am-1:30pm |
Session V | Product Development Considerations on the Use of Nanoparticles in Drug Formulation
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| A Successful Case of Biotechnology Transfer from University to a Start Up: The Story of Novagali Pharma
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Scale Up Processes on Simulation Platforms
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| Quality by Design Approach in Biopharmaceutical Products
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| Concluding Remarks
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Registration Fees
The per person registration fee for the Conferences (exclusive of accommodations) is:
Challenges in Global Product Development: Developing Rugged and Robust Products, Processes and Specifications
Student rate: $350 (US dollars), $450 after February 16
Academia rate: $450 (US dollars), $550 after February 16
Industry/others rate: $600 (US dollars), $700 after February 16Pre Conference Special Course - Advances in Nanoparticle Technologies for Pharmaceutical Development: Principles and Case Studies
Student rate: $170 (US dollars), $270 after February 16
Industry/Academia/Others: $380 (US dollars), $480 after February 16Please note: Proof of student/academia status will be required at conference check-in. If you do not have proof you will be billed/charged at the full rate.
Registration fee includes:
- Conference presentations
- Breaks and Buffet Luncheon
- Presentation materials from faculty
Cancellations: Written notification of the intent to cancel received by February 16, 2009 will result in a refund of the registration fee minus a $100 (USD) non-refundable deposit. After February 16, 2009, no refunds will be issued.
This conference will adjourn on April 2nd at 1:30pm.
For More Information
For Registration Information:
Extension Services in Pharmacy
777 Highland Avenue
Madison, WI 53705-2222 USA
PHONE: + (608) 262-3130
FAX: + (608) 262-2431
Send Email
For Program/Location Arrangements
Prof Ron Kenett
ron@kpa.co.il
Israel
Melvin Weinswig
Dean Emeritus & Professor Emeritus
University of Wisconsin-Madison
USA
Email Mel
Planning Committees
Local Organizing Committee:
Jean Paul Lellouche, Shlomo Margel - Bar Ilan University
Ron Kenett, Michael Dalith - KPA
Alex Weisman, Esther Urkin - Perrigo
Scientific Committee:
Melvin Weinswig - University of Wisconsin
Alan Hanson - University of Wisconsin
Louis Yu - Perrigo
Galen Radebaugh - Wyeth
Rafi Hofstein - Hadassit
Yafit Stark - Teva
Amira Zeevi - Perrigo
David Steinberg - Tel Aviv University
Sponsor Information
Companies/Institutions providing sponsor support for this program:
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University of Wisconsin-Madison |
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Bar-Ilan University |
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Perrigo |
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Teva |
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KPA Ltd. |
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VisiMix |
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Enbis |
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Sol-Gel Technologies |
Sponsors: Payments should be made to the University of Wisconsin-Madison.
Check or money orders maybe mailed to:
Extension Services in Pharmacy
777 Highland Avenue
Madison, WI 53705 USA
To pay by credit card, please call 608-262-3132 with Master, American Express, or VISA.
For electronic transfer please contact Kay to request necessary information.
