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Event Details
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SAPA-GP Workshop: Non-Clinical Drug Safety Evaluation (Sino American Pharmaceutical Professionals Association - Greater Philadelphia chapter). Expected Attendance: 225 scientists.
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The obstacles to successful drug development are numerous and well appreciated. Despite huge outlays by the worldwide pharmaceutical research enterprise, the number of new chemical entities brought to market has actually declined in recent years, even as the cost of developing them has increased significantly. Safety is one of the two major factors of the lower success rate from preclinical development to lunch first-in-man studies, eventually to support marketing.
- This program will include the fields of DMPK and non-clinical safety assessment.
- Presentations will be given by experienced industry scientists/leaders to address the science, process and regulatory expectations.
- The DMPK talk is to provide participants an appreciation of the role metabolism in the drug safety evaluation (e.g., toxicokinetics and toxic metabolites).
- Non-clinical safety development program, focused on toxicology and safety pharmacology, is designed to support the safe clinical use of biopharmaceuticals.
- The ICH M3 R2 guidance continues to drive the program. A strategic/predictive non-clinical safety program describing the purpose, scope, and timing of a series of non-preclinical studies supports clinical plan and marketing approval of new products.
- The non-clinical safety program enables to provide high quality information/available earlier used to make quick/informative decisions about safety in normal humans and application to specific patient populations.
- The attendee will learn key concepts in the considerations for designing a non-clinical safety development program for a biopharmaceutical product to advance a compound or “kill” a compound efficiently.
Please bring this program highlight to the attention of your friends, colleagues and business associates. We look forward to welcoming you to the member conference/workshop of non-clinical safety assessment program.
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Where
PineCrest Country Club
101 Country Club Drive
Lansdale,
PA 19446
Other Maps:
Hosted By
PCI Pharma
A Division of PlanetConnect
With over a 15 Years of experience in Fast-Track Symposia events and over 2000 exhibitor/partners, Fast-Track events have become an accepted
standard mechanism for taking the work out of research meetings. From
internal corporate R&D meetings of 30 to 2000 to public research events of 50 to 500 scientists, we have helped educate and network the Life Science research community.
