Preliminary Program - American Association of Pharmaceutical ...
Preliminary Program - American Association of Pharmaceutical ...
Preliminary Program - American Association of Pharmaceutical ...
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18<br />
2009 AAPS Annual Meeting and Exposition<br />
Meeting at a Glance<br />
TUESDAY MORNING ROUNDTABLES<br />
9:00 am – 11:00 am<br />
How to Face and Successfully Defend FDA and Other<br />
Regulatory Audits (APQ & RS)<br />
Latest Developments <strong>of</strong> Drug Targeting to Cancer<br />
Stem Cells (BIOTEC)<br />
Critical Role <strong>of</strong> CMC Project Management in the Drug<br />
Development Process (MSE)<br />
To Test or Not to Test? Risk Assessment Approaches<br />
for Human Metabolites (PPDM)<br />
Impact <strong>of</strong> Changing Regulations on Post-approval<br />
CMC Changes: U.S. and E.U. Perspectives (RS)<br />
AAPS EXPOSITION<br />
9:30 am – 6:15 pm<br />
TUESDAY AFTERNOON PROFESSIONAL<br />
DEVELOPMENT<br />
11:00 am – 12:00 pm<br />
Transitioning between Academia and Industry<br />
12:00 pm – 1:00 pm<br />
Transitioning between Small and Large Pharma<br />
AAPS FOCUS GROUP MEMBERSHIP MEETINGS<br />
12:00 pm – 1:00 pm<br />
AAPS HOT TOPIC<br />
12:00 pm – 1:15 pm<br />
STUDENT/POSTDOC OUTREACH AND<br />
DEVELOPMENT (SPOD) ROUNDTABLE<br />
12:00 pm – 1:15 pm<br />
Paths Less Traveled: Opportunities for<br />
<strong>Pharmaceutical</strong> Scientists beyond Industry<br />
and Academia<br />
TUESDAY AFTERNOON ROUNDTABLES<br />
Funded by a Grant from<br />
TUESDAY AFTERNOON PROFESSIONAL<br />
DEVELOPMENT<br />
2:00 pm – 4:00 pm<br />
Facilitation Skills<br />
TUESDAY AFTERNOON SYMPOSIA<br />
2:00 pm – 4:30 pm<br />
New Frontiers in Biologics: Advances & Challenges<br />
in PEGylation and Alternatives to PEGylation<br />
(BIOTEC)<br />
State-<strong>of</strong>-the-Art Approaches to Drug Design: Case<br />
Studies <strong>of</strong> Successful Applications <strong>of</strong> Drug Design<br />
Techniques to Identify Clinical Candidates (DDD)<br />
Challenges and Application <strong>of</strong> Dissolution for<br />
Testing Nutraceuticals, Natural Products, and<br />
Traditional Medicines (APQ)<br />
Reactive Metabolites in Drug Discovery and<br />
Development: How Can We Handle the Risk?<br />
(PPDM)<br />
Pros and Cons <strong>of</strong> Emerging Methods in Population<br />
PK and Exposure/Response Analysis (PPDM)<br />
Leveraging Prior Quantitative Knowledge in Guiding<br />
Pediatric Drug Development (CPTR & PPDM)<br />
AAPS EXPOSITION COCKTAIL RECEPTION<br />
4:45 pm – 6:15 pm<br />
Funded by Grants from AAPS Exhibitors<br />
AAPS SECTION MEMBERSHIP MEETING AND<br />
RECEPTION<br />
5:45 pm – 7:30 pm<br />
AAPS Pharmacokinetics, Pharmacodynamics and<br />
Drug Metabolism (PPDM) Section<br />
AAPS CLINICAL PHARMACOLOGY AND<br />
TRANSLATIONAL RESEARCH (CPTR) SECTION<br />
OPEN FORUM<br />
funded by grants from<br />
2:00 pm – 4:00 pm<br />
Bioequivalence Requirements: Challenges in Global<br />
Drug Development and Harmonization (RS)<br />
Inclusion <strong>of</strong> Women in Clinical Trials and Drug<br />
Development — How Far Have We Gone<br />
(CPTR & PPDM)<br />
The Pros and Cons <strong>of</strong> Development Approaches to<br />
Poorly Soluble Compounds (In-house Development<br />
and Manufacture vs. Outsourcing) (MSE)<br />
Stability Evaluations Using Alternate<br />
Accelerated Conditions (RS & APQ)<br />
Characterization <strong>of</strong> Amorphous <strong>Pharmaceutical</strong><br />
Solids and Solid Dispersions (PPB)<br />
7:00 pm – 9:30 pm<br />
An additional fee is required to attend<br />
Adequacy <strong>of</strong> PK/PD Model Validation and Simulation