【ACSS】2009-11-21CABS- Preclinical Development and IND Filing: the nuts, bolts,

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> 加州大学论坛 & ACSS UCSF 公告 / UCBBS.ORG & ACSS UCSF Announcement 【ACSS】2009-11-21CABS- Preclinical Development and IND Filing: the nuts, bolts,

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【ACSS】2009-11-21CABS- Preclinical Development and IND Filing: the nuts, bolts,
摘自加州大学论坛旧版 (Universities in California Bulletin Board System) doctliu 2009-11-16 19:08

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Hi，All

ACSS and CABS will hold a Scientific Workshop on Nov-21,2009. UCSF students/postdocs can sign up as CABS members; $1 online; $5 on site. See enclosed.

Preclinical Development and IND Filing: the nuts, bolts, and best practices

Date/Time: Sat., Nov 21, 2009; 1:00 – 5:00 PM (Check-in time: 12:30 – 1:00 pm)
Venue: UCSF Mission Bay, Genentech Hall Auditorium, 600 16th Street, San Francisco, CA, 94158
Fees: Online $1 for members, $10 for non-members;
On-site: $5 for members, $15 for non-members
Slide Handout: $10 (online only).
Register at www.cabsweb.org

Workshop Outline:

Investigational new drug (IND) application is an important milestone that marks the entry of a molecule into clinical development. Knowing the objectives, expectations, and processes of assembling and filing an IND is the key to not only a successful filing but also a promising clinical development path forward. Therefore, keeping up to date on the regulatory requirements and the industry’s best practices in different aspects including non-clinical safety, PK, CMC, and clinical plan is paramount. In this workshop, our speakers highly experienced with IND filings will discuss systemically the preclinical studies required for small molecule IND filings and the nuts, bolts, and best practices for putting together a high-quality IND package, as well as how to interact with various regulatory agencies. Below are the topics to be covered:

- Overview of preclinical development and IND filing
- Various preclinical studies required (Safety, DMPK & CMC)
- Clinical Development plans
- Interfacing with regulatory agencies including FDA

摘自加州大学论坛旧版 (Universities in California Bulletin Board System) doctliu 2009-11-16 19:08