PROGRAM

Day Morning Afternoon Evening Sunday, Aug 29, 2010      Registration & Welcoming Reception Monday, Aug 30, 2010 APIs and Stability Preformulation SPECIAL TOPIC: “Brand Versus Generic:  A Hypothetical Lifecycle of a Molecule”.  Tuesday, Aug 31, 2010 General Formulation & Process Development Guidelines Milling, Mixing and Flow SPECIAL TOPIC: “Use of Artificial Intelligence Tools in  Pharmaceutical Applications - Expert Systems” Wednesday, Sep 1, 2010 Granulation Tabletting/ Compaction DINNER WITH PARTICIPANTS Thursday, Sep 2, 2010 Film Coating Technology Transfer SPECIAL TOPIC: War Stories- Failures and Solutions: The Issues which will keep you up at night! Friday, Sep 3, 2010 Overview of Drug Delivery Technologies        ISSUES & PRESENTERS    Sunday, August 29, 2010    Registration & Welcoming Reception DAY 1 Monday, August 30, 2010 Morning Session (Module 1) APIs and Stability Issues:         Solubility; polymorphism; processibility; establishing an appropriate stability program; Identifying stability issues; designing formulations to maximize stability; dealing with stability problems Presenter:   Dr. Harry G. Brittain            Afternoon Session (Module 2) Preformulation Issues:           Physico-chemical & mechanical properties of APIs & excipients Presenters:   Dr. Navnit H. Shah & Dr. Duksoon Choi Evening Session (Special Topic) Title:           “Brand Versus Generic:  A Hypothetical Lifecycle of a Molecule”.  Presenter:   William D. Hare DAY 2 Tuesday, August 31, 2010 Morning Session (Module 3) General Formulation & Process Development Guidelines Issues:     Formulation development strategies; selection of excipients (functionality considerations); importance of multi-functionality of excipients; Impact of excipients on stability and bioavailability; defining potential processing steps; potential SUPAC & and PAT related issues Presenters:    Dr. A. Waseem Malick & Dr. Metin Çelik Afternoon Session (Module 4) Milling, Mixing and Flow Issues:     Materials, process, scale-up, trouble shooting, SUPAC and PAT related issues Presenters:   Mr. Benjamin Murugesu & Mr. James K. Prescott Evening Session (Special Topic) Title:           “Expert Systems and their pharmaceutical applications”.  Presenter:   Dr. Metin Çelik DAY 3 Wednesday, September 1, 2010 Morning Session (Module 5) Granulation Issues:         Materials, process, scale-up, trouble shooting, SUPAC and PAT related issues Presenters:   Mr. Dilip M. Parikh & Mr. David M. Jones, Afternoon Session (Module 6) Tabletting/Compaction Issues:         Materials, process, scale-up, trouble shooting, SUPAC and PAT related issues Presenters: Dr. Metin Çelik Evening Session  A Night Out - Dinner with participants DAY 4 Thursday, September 2, 2010 Morning Session (Module 7) Film Coating Issues:         Materials, process, scale-up, trouble shooting, SUPAC and PAT related issues Presenters:   Prof. Linda Felton & Dr. Stuart C. Porter Afternoon Session (Module 8) Technology Transfer Issues:         Materials, process, scale-up, trouble shooting, SUPAC and PAT related issues Presenters:   Dr. Russ Somma and Dr. Hashim Ahmed Evening Session Special Topic)     Title:            "War Stories- Failures and Solutions: The Issues which will keep you up at night! Presenter:   Dr. Russ Somma DAY 5 Friday, September 3, 2010 Morning Session (Module 9)   Overview of Drug Delivery Technologies Issues:          An overview of and advances in Orally Disintegrating Tablets and Modified Release Dosage Forms Presenters:   Dr. Stuart Porter and Charlie Cunningham Important Note: Please note that there may be an inevitable change in the program (such as replacement of a speaker) due to any reason.  In such a situation, we will spend every effort to keep the high standard of this program, however PTI Inc will not be hold liable for any consequences of such a matter.   Please also bear in mind that one of the important features of this training program is that we intend to have a very fruitful, comprehensive, and interactive sessions in which, all participants will have ample opportunity to seek answers for the questions that they might have about the modular sessions of the day.  In order to maximize the quality and utilizations of these sessions, we encourage every attendees to provide us in well advance with the questions that they seek answers about the sessions that they will attend.  We will then pass these questions to the speakers prior to the event.