PROGRAM

Day Morning Afternoon Evening         Monday Aug 26, 2013 APIs and Stability Preformulation SPECIAL SESSION: Formulation Development Strategies for Poorly Insoluble Drugs - Part 1   Tuesday August 27, 2013 Formulation & Process Dev. Guidelines Part 2     Milling, Mixing and Flow SPECIAL SESSION: EXPERT SYSTEMS AND DATABASES Wednesday August 28, 2013 Granulation   Tabletting/ Compaction   DINNER WITH PARTICIPANTS Thursday August 29, 2013 Film Coating   Technology Transfer     SPECIAL SESSION: Formulation Development Strategies for Poorly Insoluble Drugs - Part 2 Friday August 30, 2013 Overview of Drug Delivery Technologies                  ISSUES & PRESENTERS  DAY 1 Monday, August 26, 2013 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            Module 2 Preformulation Issues:           Physico-chemical & mechanical properties of APIs & excipients Presenters:   Dr. Navnit H. Shah & Dr. Duksoon Choi Special Session: Formulation Development Strategies for Poorly Insoluble Drugs - Part 1 Presenter:     Dr. Navnit H. Shah DAY 2 Tuesday, August 27, 2013 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 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 Special Session Expert Systems and Databases Presenter:   Dr. Metin Çelik DAY 3 Wednesday, August 28 2013 Module 5 Granulation Issues:         Materials, process, scale-up, trouble shooting, SUPAC and PAT related issues Presenters:   Mr. Dilip M. Parikh & Mr. David M. Jones, Module 6 Tableting/Compaction Issues:         Materials, process, scale-up, trouble shooting, SUPAC and PAT related issues Presenters:  Dr. Metin Çelik and Dr. Colleen E. Ruegger A night out with the participants   DAY 4 Thursday, August 29, 2013 Module 7 Film Coating Issues:         Materials, process, scale-up, trouble shooting, SUPAC and PAT related issues Presenters:   Prof. Linda Felton & Dr. Stuart C. Porter Module 8 Technology Transfer Issues:         Materials, process, scale-up, trouble shooting, SUPAC and PAT related issues Presenter:  Dr. Russ Somma Special Session: Formulation Development Strategies for Poorly Insoluble Drugs - Part 2 Presenter:     Dr.David Goldman (TBC) DAY 5 Friday, August 30, 2013 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 C. Porter and Mr. Charlie Cunningham Important Note: Please note that there may be an inevitable change in the program (such as replacement of a speaker, some topics, or hotel location) 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.