The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: April 16, 2019 at 9am to April 17, 2019 at 6pm
Location: DoubleTree by Hilton Philadelphia Airport, 4509 Island Avenue, Philadelphia, PA 19153
Street: Philadelphia, PA
City/Town: Philadelphia, PA
Website or Map: https://www.globalcompliancep…
Event Type: seminar, on, phase, i, gmps
Organized By: John Robinson
Latest Activity: Feb 14, 2019
Course "Seminar on Phase I GMPs" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs.
This workshop will review the current regulations, guidance documents for early stage manufacturing and GMPs in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.
Why Should you Attend:
Attend this conference so that you may understand differences between GMP requirements for early and later stage clinical development. Explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.
Location: Philadelphia, PA Date: April 16th & 17th, 2019 and Time 9:00 AM to 6:00 PM
Venue: DoubleTree by Hilton Philadelphia Airport, 4509 Island Avenue, Philadelphia, PA 19153
1 ATTENDEE $2,000, Regular Price: $2000, Register for 1 attendee
5 ATTENDEES $10,000, Regular Price: $10,000, Register for 5 attendees
10 ATTENDEES $20,000, Regular Price: $20,000, Register for 10 attendees
Until March 10, Early Bird Price: $2,000. From March 11 to April 12, Regular Price: $2,200.
Use this promo code GCP50 to get 50% off.
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NetZealous LLC DBA GlobalCompliancePanel
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